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Case Report from the EHR4CR Project—A European Survey on Electronic Health Records Systems for Clinical Research

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Case Report from the EHR4CR Project—A European Survey on Electronic Health Records Systems for Clinical Research

Abstract

Objective: The Electronic Health Records for Clinical Research (EHR4CR) project aims to deliver a new technological platform and business model to enable the re-use of patient information from electronic health records (EHRs) for clinical research in Europe. An EU electronic survey (e-survey) was conducted to identify opportunities and issues pertaining to the development and implementation of cost-effective EHR4CR clinical services. Methods: The EU e-survey was conducted in two waves: with participating stakeholders from the public and private sectors involved in the EHR4CR consortium, and with non-participating informed stakeholders. Results: The results confirm a high interest in re-using EHR data for clinical research with the objective of optimizing drug development efficiency and access to innovative medicines in Europe. Key challenges include privacy protection, systems interoperability, patient acceptance, and ethical considerations. Conclusions: The re-use of EHR data for clinical research represents a unique opportunity. This survey highlights the importance for the EHR4CR platform and business model to address the respective needs and incentives of relevant stakeholders to provide sustainable EHR4CR solutions in Europe.
108 © TOUCH BRIEFINGS 2011
Business Strategy
Case Report from the EHR4CR Project—A European Survey on Electronic
Health Records Systems for Clinical Research
Dipak Kalra,1Andreas Schmidt,2HWW Potts,1Danielle Dupont,3M Sundgren4and Georges De Moor,5on behalf of the
EHR4CR Research Consortium
1. Centre for Health Informatics and Multiprofessional Education, University College London; 2. F Hoffman-La Roche, Basel; 3. Data Mining International, Geneva;
4. AstraZeneca, Mölndal; 5. University of Gent
Dipak Kalra is Director of the Centre for Health Informatics and Multiprofessional Education at University College London, and a former
general practitioner. He plays a leading international role in the research and development of electronic health record (EHR) architectures
and systems, covering requirements, information models, representation of clinical meaning, and protection of privacy. He has led the
development of the international standards on EHR interoperability, personal health records, EHR architecture requirements, and several
standards on EHR security and confidentiality. Dr Kalra is a Director of the openEHR foundation, Vice President for Research at the
EuroRec Institute, and an advisor to the European Commission on semantic interoperability.
Andreas Schmidt has been an eHealth systems leader since 2009. He is involved in projects evaluating opportunities around electronic
health record patient level data for F Hoffmann La Roche Pharma Product Development. He has held various roles in clinical development
including cardiac safety, business development, and information management at Novartis Pharma AG and Ciba-Geigy AG in the past
20 years. With more than 10 years of working in public healthcare, Andreas has extensive experience in medical diagnostics and treatment,
scientific research, and patient care.
Danielle Dupont holds a BA in pharmacy, an MSc in sciences (University of Montreal, Canada), and a PhD in health economics (University Claude Bernard Lyon I,
France). She cumulates more than 20 years of international experience, gained in North America and Europe, within leading pharmaceutical companies. She has had
senior leadership roles in the areas of market access, health economics and outcomes research strategy, pricing and reimbursement, value demonstration, and
business model innovation, to optimize access to health technologies across disease areas and life cycles at the global, regional, and local levels. A health economic
expert and opinion leader, she is currently Head of Data Mining America Corporation and Chief Scientific Officer at Data Mining International SA, where she advises
and leads EU and other international projects in collaboration with vast research consortiums across geographies.
Disclosure: Danielle Dupont received direct financial contributions from Data Mining International SA,designated sub-contractor to the EHR4CR
consortium (European Federation of Pharmaceutical Industries and Associations participants). The remaining authors have no conflicts of interest to declare.
Correspondence: d.kalra@ucl.ac.uk Citation: iHealth Connections, 2011;1(2):108–13
Acknowledgments: EHR4CR (www.ehr4cr.eu) is sponsored by the Innovative Medicines Initiative, a public-private partnership program of the
European Commission and the European Federation of Pharmaceutical Industries and Associations (www.imi.europa.eu).
Objective: The Electronic Health Records for Clinical Research (EHR4CR) project aims to deliver a new technological
platform and business model to enable the re-use of patient information from electronic health records (EHRs)
for clinical research in Europe. An EU electronic survey (e-survey) was conducted to identify opportunities
and issues pertaining to the development and implementation of cost-effective EHR4CR clinical services.
Methods: The EU e-survey was conducted in two waves: with participating stakeholders from the public and
private sectors involved in the EHR4CR consortium, and with non-participating informed stakeholders.
Results: The results confirm a high interest in re-using EHR data for clinical research with the objective of
optimizing drug development efficiency and access to innovative medicines in Europe. Key challenges include
privacy protection, systems interoperability, patient acceptance, and ethical considerations.
Conclusions: The re-use of EHR data for clinical research represents a unique opportunity. This survey highlights
the importance for the EHR4CR platform and business model to address the respective needs and incentives of
relevant stakeholders to provide sustainable EHR4CR solutions in Europe.
Schmidt_v1_iHC US 13/12/2011 09:28 Page 108
Case Report from the EHR4CR Project
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Electronic Health Records for Clinical Research (EHR4CR) is a four-year
project sponsored by European public funds through the Innovative
Medicines Initiative under the 7th Framework Program of the
EU Commission and by in-kind contributions from the European
pharmaceutical industry. This public–private research initiative involves
EU experts from academia and from the European Federation of
Pharmaceutical Industries and Associations.
The EHR4CR project will deliver an innovative platform and a sustainable
business model to enable the re-use of data from electronic health
records (EHRs) for clinical research purposes in Europe. More
specifically, the EHR4CR project will develop a state-of-the-art
interoperable platform to enable heterogeneous EHR systems to re-use
patient data for clinical research, in full compliance with applicable
legislative, regulatory, ethical, and privacy protection requirements
and policies across Europe. For the first time, the EHR4CR platform and
business model will provide a systematic, structured, and scalable
approach to the re-use of EHRs data for clinical research. Ultimately, the
EHR4CR platform is intended to streamline existing clinical research
processes, attract further research and development investments, and
optimize access to innovative medicines in Europe. As a result, the
re-use of EHR data will benefit healthcare professionals, clinical
researchers, regulators, patients, and society.
However, these solutions will need to address specific needs and
challenges and secure acceptance from patients, the public, and the health
service community. As part of a larger environmental scan initiative, this
article presents the results of an EU electronic survey (e-survey) recently
conducted among EU stakeholders from the public and private sectors to
address the key opportunities and challenges pertaining to the optimal
development and implementation of EHR4CR services in Europe.
Background
The development of new medicines is critical to maintain and advance
improvements in healthcare. However, the discovery of new medicines
has become increasingly challenging. Current unmet medical needs,
ageing populations, long-term management of chronic diseases, and
personalized medicines contribute to an increasing healthcare
demand. The concurrent escalation in healthcare expenditures also
contributes to building unprecedented pressure on healthcare systems
in Europe and around the world.
In parallel, the average cost of conducting clinical trials has increased
three-fold over the last 12 years.1In 2006, the cost of researching,
developing, and achieving regulatory approval for a new chemical or
biological entity was estimated at €1.1 billion.2The total research
and development (R&D) cost across the industry was estimated at
€710–790 billion in 2007, with an annual growth rate of 10.2–13.6 % since
2003.3Clinical research accounts for around 75 % of these R&D costs.
The lengthy clinical development processes (average eight to 10 years)
combined with the ever more challenging market access conditions for
new compounds also negatively impact the pharmaceutical sector.
Furthermore, between 1990 and 2008, R&D investments in the US grew
by 5.6-fold, while in Europe it only grew by 3.5-fold. This confirms
Europe’s relative lack of attractiveness for pharmaceutical R&D
investment. Today, there is rapid growth in the research environment in
emerging economies such as China and India, resulting in closure of
R&D sites in Europe and opening of new sites on the Asian continent.2
Clinical research is also growing in complexity and labor intensity. This
is, in part, attributable to the need to conduct large clinical trials that
provide definitive evidence of clinical efficacy and safety. There is also a
rising demand to assess comparative effectiveness in routine medical
practice, which may require conducting extended non-interventional
studies. Further issues include the difficulty of targeting the right patient
populations, optimizing study protocol designs, identifying suitable
patients for clinical trials, re-entering redundant clinical data manually,
and detecting and reporting infrequent adverse events in a timely
manner. All these factors explain the motivation from developers to
transform current clinical research models to bring innovative medicines
to market faster and at lower cost.
Recent developments in EHRs now increasingly provide opportunities to
re-use the data they contain for clinical research purposes. The
considerable progress made in seamlessly integrating EHRs within
existing healthcare networks offers new possibilities for private- and
academic-sector researchers to conduct clinical trials more efficiently.
However, issues remain. Access to EHRs for research is often limited,
and those that are available are not always representative of the whole
population from which patients may be recruited. It is currently very
difficult to perform research queries across multiple EHRs and
turnaround times are lengthy; this makes rapid, dynamic ‘what-if’
analysis almost impossible.
This is why state-of-the-art, data-driven protocol feasibility has been only
slowly adopted across wide portfolios or entire research organizations.
The consequences of not optimizing protocols are: increased protocol
amendments, slower than expected enrolment, costly changes to add
new sites and countries, and, sometimes, even failed trials. Almost half
of all trial delays are caused by participant recruitment problems4and
the percentage of studies that complete enrolment on time is extremely
low across all clinical trial markets: 18 % in Europe, 17 % in Asia-Pacific,
15 % in Latin America, and 7 % in the US.5
Today, clinical trial data are entered into dedicated electronic clinical
trial systems and the same information is often also entered into the
institution’s EHR system. Connecting healthcare and clinical trial systems
for data exchange could reduce or even avoid the redundant data entry
occurring today. Various studies have established that over 40 % of
clinical trial data are entered into the patient’s health record, the clinical
trial EDC system, and, possibly, a third paper copy.6,7 Investigational sites
estimate that over 70 % of data are duplicated between EHR and clinical
trial systems.8
There is now a growing realization that the ability to effectively integrate
and interoperate advanced EHR systems within healthcare networks
represents a unique opportunity to enhance academic research, to
speed up existing processes, and to build greater efficiency. These
advances promise to address significant unmet medical needs more
expediently, to improve patient safety, and to optimize access to
innovative medicines for better health outcomes.
Schmidt_v1_iHC US 08/12/2011 16:49 Page 109
To that end, the EHR4CR platform will be tested in pre-defined disease
areas for relevant applications of interest which include clinical trial
feasibility, patient recruitment, clinical trial execution, and adverse event
reporting. This will be achieved by combining areas of previously
isolated medical informatics progress (e.g. semantic interoperability,
privacy-enhancing techniques and standards) in an entirely new
integrated approach with the aim of enabling the re-use of EHRs for
clinical research through optimal data extraction and aggregation,
de-identification, linkage, and security. To ensure the delivery of
high-quality and cost-effective solutions, the EHR4CR platform will also
be supported by specific governance (including advanced accreditation
and certification programs) and by a sustainable business model.
There are other projects investigating better approaches to re-using
EHR data for clinical research. TRANSFoRm is an EU project developing
computational services to enable the re-use of general practice EHR
data for clinical research. PONTE (Efficient Patient Recruitment for
Innovative Clinical Trials of Existing Drugs to other Indications) is a
three-year EU research project (2010–2013) developing a platform for
automatic identification of patients eligible to participate within
specified clinical trials. PACeR (Partnership to Advance Clinical
electronic Research) is a new US-sponsored project aiming to design
processes to help to more quickly and easily match patients to clinical
trials. All of these projects expect to undertake some business modeling
investigations, but none has as yet been published.
Among the multiple ongoing environmental scan initiatives and
evidence-based approaches being deployed, this article presents the
methods and results of an EU e-survey conducted with informed
European stakeholders to address key opportunities and challenges in
developing and implementing a sustainable pan-EU EHR4CR capability.
Methods
An EU e-survey was conducted with informed stakeholders to scan the
environment relevant to the EHR4CR project, with the objectives being to:
collect further insights on the advantages and value of EHR4CR
clinical services;
uncover potential key issues to address and opportunities to explore;
identify key drivers and challenges for delivering/implementing/
using EHR4CR services;
detect early signals to guide the development of innovative
customized services; and
inform the design of a sustainable business model for EHR4CR
services in Europe.
This survey consisted of a self-administered electronic questionnaire
which was developed, piloted, and validated by a designated task force
within the EHR4CR consortium. The questionnaire included a brief
description of the EHR4CR project (background, rationale, and research
environment), and comprised 30 multiple-choice questions covering
three themes, namely:
about you and your organization;
about the EHR4CR platform and services; and
factors affecting the EHR4CR platform and services.
The survey was conducted in two successive waves. Using an ‘internal’
perspective, the first wave was conducted from June 22, 2011 to July 4,
2011 with participating EU EHR4CR partners already involved in
the EHR4CR project. Two electronic reminders were sent to the
participants prior to the survey deadline and 78 respondents
completed the survey. Using an ‘external’ perspective, the second
wave was conducted from July 5, 2011 to September 16, 2011 with
informed external stakeholders and collaborators not participating in
the EHR4CR project. Two electronic reminders were sent to the
participants prior to the survey deadline and 125 respondents
completed the survey.
The results from both waves were analysed separately and then
compared to identify main areas for improvement in clinical research,
key opportunities and challenges, and expected benefits from
EHR4CR services.
Results
Respondents to this survey comprised stakeholders from academic
centers (n=42), the pharmaceutical industry (n=), information technology
(IT) providers and EHR and electronic data capture (EDC) system
vendors (n=38), clinical research organizations and research sites (n=28),
patient advocacy groups (n=4), health agencies (n=4), and other relevant
sectors (n=20). One-third of the academic centers and almost all of the
pharma respondents were members of the EHR4CR consortium (i.e.
internal stakeholders), whereas most of the other respondent categories
were external. Most respondents had been involved in their respective
field for over 15 years, and so these survey results reflect substantial
experience from these sectors.
Overall, 23 EU countries were represented in this survey. The majority of
respondents came from the UK (n=39), Germany (n=36), Belgium (n=24),
Sweden (n=21), Switzerland (n=15), and France (n=14).
Importantly, the results from both waves of respondents showed a high
degree of consistency across most aspects surveyed.
Main Areas for Improvement in Conducting
Clinical Research
For internal and external respondents, the greatest aspects of current
clinical trials practice needing improvement are identifying patients for
participation in clinical trials (70 %), optimizing the time currently
required to conduct clinical trials (59 %), reducing the costs (54 %) and
workload of conducting clinical trials (54 %), and evaluating clinical trial
protocol feasibility (50 %).
Most respondents proposed the highest priority for EHR4CR platform
services to be evaluating patient populations and identifying patients for
clinical trials. Exchanging data between EHRs and clinical trials was also
considered a priority. The detection and reporting of adverse events
was considered a lower priority by pharma but the highest priority by the
small number of patient advocacy representatives who participated in
this survey. These results are not surprising: safety is often viewed as a
secondary end-point, while targeting the right patient population and
recruiting patients is a prerequisite to demonstrating efficacy (the
primary end-point).
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Case Report from the EHR4CR Project
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Key Opportunities
A large proportion (44 %) of the respondents had noted a strong or
increasing societal or cultural trend towards the re-use of EHR data for
clinical research. This trend largely being perceived as new and not yet
wide-scale is one of the key motivations behind the Innovative
Medicines Initiative call topic that EHR4CR is addressing.
Nearly all the respondents (95 %) were personally in favor of re-using EHR
data for research. However, a small sub-group of external stakeholders
(eight of 125, 6 % of the external survey respondents) were not at all in
favor of this. This sub-group was not significantly associated with any
specific industry sector or country. Further understanding about the
reservations perceived by certain stakeholder types may emerge through
the in-depth interviews planned in the next phase of this project.
Regarding the opportunity of new technological developments, the
majority of academic (74 %), clinical research (82 %), and vendor
respondents (92 %) classified themselves as innovators or early adopters
of new information technology, whereas only 57 % of pharma
respondents did so. These classifications did not differ significantly by
country. This late adoption by pharma may be explained by large size
organizations (which likely require more time and resources for
implementation), by other organizational priorities or movements, or by
the need to be extra cautious for risk management purposes.
Most respondents (67 %) indicated that they find it challenging to attract
the human or financial resources needed for new clinical research
applications within their organizations. Most considered that their
organization was in a position to implement and use EHR4CR services
(44 % ‘good’ and ‘excellent’; or 81 % ‘fair’, ‘good’, or ‘excellent’);
however, a significant difference was observed between IT providers and
clinical research sites, which considered themselves to be in a good
position on average (median), and academic centers and pharma, which
only considered themselves in a fair position. This suggests that training
may be needed in some sectors to support the implementation of
EHR4CR services.
The research domains perceived by respondents as areas that could
benefit the most from EHR4CR services are listed in Figure 1. Regarding
the opportunity to develop partnerships with specific stakeholders,
respondents considered the groups shown in Figure 2 to be essential to
achieve the full potential of the EHR4CR platform. Fifty-seven percent
of respondents were keen to see the creation of an EU network of
excellence for the use of EHRs for clinical research. Customized training
for end users of the EHR4CR services, with ready access to experts who
could guide on its use for specific application domains, was also
considered important, as was a helpdesk. Assigning EHR4CR champions
at each research facility was also perceived as potentially helpful.
When considering who should fund EHR4CR services, by far the most
nominated candidate was governments (90 %), indicating that the
majority see this service as a public resource even if used by pharma.
Pharma was itself the second most proposed candidate (68 %) to fund
EHR4CR services, and public health agencies the third (50 %). There was
a high degree of consistency between the two groups surveyed. Moving
forward, different funding schemes will nonetheless have to be
prototyped to identify the most relevant and sustainable EHR4CR
business model.
Figure 3 illustrates the groups identified by respondents as being
the expected contributors of data, resources, and services for the
EHR4CR platform.
Figure 1: Research Domains of Interest for EHR4CR Services
Health economics and outcomes research
Public health research
Epidemiological research
Comparative effectiveness research
Translational research
Non-interventional (observational) research
Medical informatics research
Clinical research
0706050403010 20
Figure 2: Groups/Organizations with Whom It Was
Perceived Essential for EHR4CR to Build Partnerships
General and specialized medias
Trusted third parties
Public health agencies
Clinical investigators
Hospitals
Governments
Clinical research sites
Pharmaceutical industry
0706050403010 20
EHR/EDC vendors
Patients advocacy groups
Academic centers
Figure 3: Groups Expected to Be Contributors (of Data,
Resources, and Services) to EHR4CR Services
Governments
EHR/EDC vendors
Academic centers
Public health agencies
Trusted third parties
Pharmaceutical industry
Patient advocacy groups
Clinical investigators
0706050403010 20
Clinical research sites
Hospitals
Schmidt_v1_iHC US 13/12/2011 09:29 Page 111
Key Challenges
Respondents from all sectors and countries, both internal and external
to the project, all rated complying with legislative, regulatory, ethical,
and privacy protection requirements as the strongest driving force for
successfully implementing, delivering, and using EHR4CR services (95 %
rating it highest or highest equal). This may be because respondents
clearly recognized that significant ethical and confidentiality concerns
have to be overcome if EHR data are to be re-used for research,
especially across countries. Tackling these issues is a key component of
the EHR4CR work plan. Systems interoperability and demonstrating
value for money were the next two high-priority drivers for all
respondent categories.
Responses to the next question highlighted similar concerns, also across
all respondent types. Among the main challenges, gaining acceptance
from patients and all stakeholders was considered to be EHR4CR’s
greatest hurdle (93 % rating this highest or highest equal). Delivering
services to a high quality in real-life settings, having a platform that is
generic and comprehensive enough to address multiple clinical research
scenarios, and flexibility of services were the other challenges
considered most important to address.
Expected Benefits
Twenty-two percent of respondents considered improved efficiency to
be the most important gain to clinical research from EHR4CR solutions.
Standardization was also ranked highly (18 %), but a higher proportion of
respondents (34 %) indicated that improved efficiency, standardization,
quality, time optimization, and faster access to innovative medicines
were all equally essential benefits.
When asked about the most distinctive advantages of the EHR4CR
platform to their organization, the majority response across both internal
and external stakeholders (68 %) was unequivocally the delivery of
reliable, high-quality, and cost-effective services for the re-use of EHR
data for clinical research. Other frequently chosen advantages were the
optimization of clinical research processes for the public and private
sectors (42 %) and the elimination of non-value-added tasks, such as
re-entry of data and trial-specific paperwork (42 %). Improved patient
safety from early detection and reporting of adverse events (30 %) was
also considered important.
When asked to indicate the same advantages of the platform, but this
time to clinical researchers, the same three factors were ranked most
highly, with elimination of non-value-added tasks coming top (56 %).
Improved patient safety from early detection and reporting of adverse
events (31 %) and clarification of the source of data used for clinical
research (30 %) were also nominated as important.
When asked about the same advantages, this time to patients, faster
access to safe and effective medicines (75 %) and improved patient
safety from early detection and reporting of adverse events (75 %) were
overwhelmingly the most popular advantages, with similar high rankings
across all respondents.
When asked finally about advantages to society, most responded
similarly to the advantages to patients. However, the optimization of
clinical research processes for the public and private sectors (38%),
the establishment of EU best practices in e-clinical research (34%),
and the opening of new opportunities for the public sector from
innovative clinical services (32 %) were also highlighted as an
important advantage.
Discussion
Science today offers greater promise for finding better treatments than
ever before, thanks to new knowledge, innovative medicines, and
technologies.2However, the increasing healthcare demand, the
emerging personalized medicine era, and the escalating healthcare
costs require better integration of three main drivers: biological
sciences, information management, and healthcare collaboration. The
main opportunity consists of optimizing information exploitation to
enable scientific knowledge discovery and efficiency of new drug
development platforms. The corresponding challenge resides in how to
best access, connect, manage, and exploit the relevant health
information available within and beyond clinical trials, including clinical
research legacy data, external research databases, biomedical literature,
and EHRs. All these environments contribute to defining a vast
information landscape.9This addresses the need to realize a substantial
transformation of existing platforms and systems to enable their
evolution, in compliance with relevant legal, ethical, privacy protection,
and regulatory considerations and frameworks.
In its ideal form, the EHR is a longitudinal electronic record of patient
health information generated by one or more encounters in any care
delivery setting. The adoption of EHRs in hospitals, community
centers, and private practices has been steadily increasing and offers
new possibilities to improve the delivery, quality, and continuity of
clinical care.10–13 However, there are obvious obstacles to using EHRs in
clinical research, including EHR fragmentation, diverse and
independent systems that to not adhere to standards, and substantial
technological and implementation challenges. In particular, such
ambition requires enabling interoperability (encompassing technical,
functional, legal, and organizational aspects) to ensure seamless
cross-border connectivity for optimal electronic data collection and
exchange between systems.
Importantly, it is worth mentioning that the findings of this EHR4CR
e-survey are strongly consistent between internal and external
stakeholders. Both confirm a high level of interest in re-using EHR
patient-level data for clinical research purposes. The results also
highlight the real challenge for the pharmaceutical industry and
research organizations to recruit patients in sufficient numbers for
clinical trials, as well as the well-recognized significant duplication of
efforts in collecting patient data. The clinical scenarios identified by
the EHR4CR project (clinical trial feasibility, patient recruitment, clinical
trial execution, and adverse event reporting) were rated as key
priorities by all stakeholders surveyed.
Ethical considerations, privacy protection issues, and acceptance of the
EHR4CR solution by patients were ranked by the stakeholders as being
the most critical challenges that the project will have to address. Other
challenges identified include the interoperability of EHR data between
diverse hospital systems and the quality and granularity of routinely
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collected clinical data, which may limit the suitability of the data for use
in clinical trials.
Notably, the results of this e-survey clearly reveal the expectation for the
EHR4CR platform to be value-driven rather than cost-driven. This means
that its services need to be demonstrably of a high quality and deliver
added benefits, improved efficiency, and value for money to its customers
and end users. In particular, the most significant benefits for research
organizations, patients, and society of re-using EHR data for clinical
research were identified by the respondents as the delivery of high-quality
and cost-effective solutions, optimization of clinical research processes,
and elimination of non-value-added tasks (redundant data entry). The
results also revealed that such improvements were expected to lead to
greater drug development efficiency, faster access to safe and effective
medicines, enhanced patient safety, and best practices in e-clinical
research through the proposed accreditation and certification programs.
While the results of this EU e-survey provide useful information, they are
nonetheless limited in scope. They will be complemented by
supplemental environmental scan initiatives undertaken by the EHR4CR
consortium, including semi-structured interviews with EU academic
experts, as well as an ongoing consultative process with public and
private EU stakeholders over the duration of the project.
Conclusions
There is increasing societal acceptance of the need for clinical
research and of the potential value of re-using EHR patient-level data
to optimize research efforts. In parallel, society in general, healthcare
systems and the pharmaceutical industry are critically concerned
about managing costs more efficiently and providing timely access to
safe and effective innovative medicines.
The rapid advancement of health information technologies (including
EHRs) now offers remarkable opportunities to optimize clinical research
potential, to streamline existing processes, and to enhance overall drug
development efficiency and access to innovative medicines in Europe.
In this context, the EHR4CR project intends to meet the ambitious
objective of establishing a scalable pan-European platform to enable
the re-use of EHR data to support the design and execution of clinical
trials and the monitoring of the safety of medicines.
This survey confirms the high interest and relevance of the EHR4CR
project with regard to EU stakeholders’ respective needs and incentives
for delivering sustainable and cost-effective solutions in Europe. These
promising possibilities and the complexity inherent to the EHR4CR
platform also require carefully addressing current opportunities and
challenges with continuous support and input from all relevant
stakeholders to enable the successful implementation of a pan-EU
EHR4CR capability and sustainable business model at project completion.
Considering that the EHR4CR platform will need to be deployed and
interface with a wide range of systems and services to support an
end-to-end user experience, this EU e-survey provides valuable
information towards achieving the development and implementation
of EHR4CR services and of a sustainable and scalable business model.
The results of this e-survey also address the many opportunities and
significant challenges ahead, including ensuring interoperability in
compliance with privacy protection, regulatory, legal, and ethical
requirements, and policies across Europe. Another challenge is the
near-universal downscaling of many national e-health programs, which
may limit the opportunity to extend the richness and interoperability of
EHR systems and of the infrastructure to enable them to communicate
at a regional or national level.
1. Webster P, The cost of clinical trials, Drug Discovery &
Development, 2005, May 18. Available at:
www.dddmag.com/biomarkers-save-clinical-trial.aspx
(accessed December 2, 2011).
2. EFPIA, The Pharmaceutical Industry in Figures. Key Data
2009. Update. 1–27.
3. Parexel Bio/Pharmaceutical Statistical Sourcebook
2008/2009.
4. Study Participant Recruitment and Retention in Clinical
Trials: Emerging strategies in Europe, the US and Asia,
Business Insights
, June 2007.
5. State of the Clinical Trials Industry: A Sourcebook of
Charts and Statistics,
Center Watch
, 2008.
6. Integrating Electronic Health Records and Clinical Trials:
An Examination of Pragmatic Issues, Michael Kahn,
University of Colorado.
7. EHR and EDC Integration in Reality, Applied Clinical
Trials, November 2009.
8. EDC Site Survey: Investigational Site Perspectives on
Clinical Trial Information Systems, eClinical
Forum 2009. Available at: www.eclinicalforum.org
(accessed December 1, 2011).
9. Sundgren M, Connection Power. The New Information
Landscape,
European Pharmaceutical Contractor Quarterly
,
2011;June:71–3.
10. Turisco F, et al., Current status of integrating
information technologies into the clinical research
enterprise within US academic health centers: strategic
value and opportunities for investment,
J Investig Med
,
2005;53:425–33.
11. West SL, Reflections on the use of electronic health
record data for clinical research,
Health Informatics Journal
,
2009;15:108–21.
12. EU: The added value of electronic health records
(EHRs): Linking patient care, clinical research and
public health, 2008. Available at: www.eurorec.org/
files/filesPublic/High_Level_Statement_EHR%20in%
20EU__FINAL%20_July%2014.pdf
(accessed December 1, 2011).
13. HIMSS Analytics Database 2001. Available at:
www.himssanalytics.org/stagesGraph.asp
(accessed December 1, 2011).
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... market [1]. The main obstacles to conducting clinical trials today include high cost, lengthy time frames, administrative barriers and delays in study execution [1,2]. Specific challenges include assessing the feasibility of study protocols, targeting the right patient populations, identifying suitable patients for recruitment in clinical trials, and enhancing clinical data exchange. ...
... Specific challenges include assessing the feasibility of study protocols, targeting the right patient populations, identifying suitable patients for recruitment in clinical trials, and enhancing clinical data exchange. These factors explain the interest of transforming existing clinical research models so to bring innovative medicines to healthcare faster, and at lower cost [2,3]. In addition, achieving success in today's economy not only demands clever innovation and highly performing technology, but agile and incentive-based business models [4]. ...
... Considering that the EHR4CR platform has considerably evolved since its inception, and given its conclusive pilot testing, it has now reached the commercialization phase and is being scaled up across Europe. Since EHR4CR solutions have been designed to enhance and speed up current practices, it is predicted that they will transform clinical research environments, and generate substantial benefits for all stakeholders involved [2,22]. Consequently, building a business ecosystem and creating sustainable business models are essential in order to successfully implement new technologies in healthcare, and to maximise the value that they can bring to health systems, healthcare organisations, care professionals, patients, care givers, citizens, and to society [23][24][25][26][27]. ...
Article
Full-text available
Introduction: The Electronic Health Records for Clinical Research (EHR4CR) technological platform has been developed to enable the trustworthy reuse of hospital electronic health records data for clinical research. The EHR4CR platform can enhance and speed up clinical research scenarios: protocol feasibility assessment, patient identification for recruitment in clinical trials, and clinical data exchange, including for reporting serious adverse events. Our objective was to seed a multi-stakeholder ecosystem to enable the scalable exploitation of the EHR4CR platform in Europe, and to assess its economic sustainability. Materials and methods: Market analyses were conducted by a multidisciplinary task force to define an EHR4CR emerging ecosystem and multi-stakeholder value chain. This involved mapping stakeholder groups and defining their unmet needs, incentives, potential barriers for adopting innovative solutions, roles and interdependencies. A comprehensive business model, value propositions, and sustainability strategies were developed accordingly. Using simulation modelling (including Monte Carlo simulations) and a 5-year horizon, the potential financial outcomes of the business model were forecasted from the perspective of an EHR4CR service provider. Results: A business ecosystem was defined to leverage the EHR4CR multi-stakeholder value chain. Value propositions were developed describing the expected benefits of EHR4CR solutions for all stakeholders. From an EHR4CR service provider's viewpoint, the business model simulation estimated that a profitability ratio of up to 1.8 could be achieved at year 1, with potential for growth in subsequent years depending on projected market uptake. Conclusions: By enhancing and speeding up existing processes, EHR4CR solutions promise to transform the clinical research landscape. The ecosystem defined provides the organisational framework for optimising the value and benefits for all stakeholders involved, in a sustainable manner. Our study suggests that the exploitation of EHR4CR solutions appears profitable and sustainable in Europe, with a growth potential depending on the rates of market and hospital adoption.
... market [1]. The main obstacles to conducting clinical trials today include high cost, lengthy time frames, administrative barriers and delays in study execution [1,2]. Specific challenges include assessing the feasibility of study protocols, targeting the right patient populations, identifying suitable patients for recruitment in clinical trials, and enhancing clinical data exchange. ...
... Specific challenges include assessing the feasibility of study protocols, targeting the right patient populations, identifying suitable patients for recruitment in clinical trials, and enhancing clinical data exchange. These factors explain the interest of transforming existing clinical research models so to bring innovative medicines to healthcare faster, and at lower cost [2,3]. In addition, achieving success in today's economy not only demands clever innovation and highly performing technology, but agile and incentive-based business models [4]. ...
... Considering that the EHR4CR platform has considerably evolved since its inception, and given its conclusive pilot testing, it has now reached the commercialization phase and is being scaled up across Europe. Since EHR4CR solutions have been designed to enhance and speed up current practices, it is predicted that they will transform clinical research environments, and generate substantial benefits for all stakeholders involved [2,22]. Consequently, building a business ecosystem and creating sustainable business models are essential in order to successfully implement new technologies in healthcare, and to maximise the value that they can bring to health systems, healthcare organisations, care professionals, patients, care givers, citizens, and to society [23][24][25][26][27]. ...
... It is estimated that almost 50% of all trial delays are caused by participant recruitment problems. Moreover, studies recruiting on time are reportedly extremely low across markets: 18% in Europe, 17% in Asia-Paciic, 15% in Latin America, and 7% in the US [5]. In addition, clinical data entry Additionally, in order to ensure that value will be optimised in a sustainable manner for all stakeholders involved, a sound business model has been developed by the EHR4CR project. he objective was to deine the most suitable organizational framework that will best contribute to creating, delivering, and optimizing value from implementing these innovative solutions in a multi-stakeholder ecosystem. ...
... Recent studies have shown that over 40% of clinical trial data are entered into the patient's health record, the clinical trial data capture system, and, possibly, a third paper copy. It is also estimated that over 70% of data are duplicated between electronic health records (EHR) and clinical trial systems [5]. All these factors contribute to slower than expected patient enrolment, signiicant study delays, and increasing costs. ...
... European project consists of one of the largest public-private research partnership funded by the European Commission and by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in the frame of the Innovative Medicines Initiative (IMI) joint actions (http://www.ehr4cr.eu/). his vast multidisciplinary research initiative has developed an innovative technological platform that enables the trustworthy reuse of health data contained in hospital-based EHR to enhance and speed up clinical research practices [5,[8][9][10]. Specially, this new platform has been designed to enhance and speed up the following clinical research scenarios, namely: he R&D eforts and technological advancements developed by the EHR4CR multidisciplinary research consortium have been described in previous publications [5,[8][9][10]. ...
Article
Full-text available
Background: The new technological platform developed by the Electronic Health Records for Clinical Research (EHR4CR) European research project (2011-2016) has been specially designed to enable the trustworthy reuse of health data contained in hospital-based electronic health records (EHR) for enhancing and speeding up clinical research scenarios. In particular, protocol feasibility assessments, patient identification for recruitment, and clinical data exchange for study conduct, in accordance with data privacy, ethical and legal requirements. The objective of our study was to assess the financial impact of adopting these advanced solutions compared to current practices, from the perspective of the primary sponsors of clinical trials in Europe.Methods: Considering a scalable implementation of EHR4CR solutions in up to 5-10% of Phase II, III and IV clinical trials to be commercially sponsored in Europe over 5 years, two potential market sizes were defined. The first has a European initial scope (i.e., for European clinical trials only), and the second has a European subsequent broader scope (also including European arms of global studies). Based on expert opinions, the EHR4CR initial scope target market was estimated to be 30% of the broader scope. Direct costs to clinical research sponsors were estimated under current practices, and with the EHR4CR platform. Uncertainty was managed using 100,000 Monte Carlo simulations. Results: Compared to current practices, the potential average 5-year savings with EHR4CR solutions for Phase II, III and IV commercially sponsored clinical trials in Europe were estimated at €175.5 m for the European initial scope market, and at €585.3 m for the European broader scope market. These results were confirmed by robust probabilistic sensitivity analyses. Conclusions: Compared to current practices, EHR4CR solutions appear cost-saving for primary sponsors of clinical trials. These results suggest that the potential for savings would increase with a broader adoption of EHR4CR solutions in Europe, and beyond.
... Nowadays, a larger body of evidence is expected to support regulatory and evidence-based reimbursement decisions [5][6][7]. In addition to clinical efficacy and safety, there is a rising demand from regulatory authorities, health technology assessors, and payers to also generate evidence of comparative effectiveness, safety and cost-effectiveness of innovative medicines compared to current treatments, including in routine medical practice [5,8]. Hence, pharmaceutical industry needs to transform its R&D infrastructures in order to improve the efficiency of clinical research processes, reduce costs, and generate more evidence faster so to deliver effective and safe innovative medicines in a timely manner [5,9,10]. ...
... As a recent pan-European survey revealed that most clinical research stakeholders in Europe would support a value-driven innovative clinical research platform [8], this cost-benefit assessment (CBA) is the first to assess the value of the EHR4CR platform compared to current practices, from the perspective of pharmaceutical industry as primary sponsors of clinical trials in Europe and worldwide. Hence, the objective of this CBA is to assess the potential added value for the pharmaceutical industry of adopting EHR4CR solutions versus current practices, as applied to oncology clinical trials as the reference case. ...
... This scenario is used to determine the number of patients across multiple sites whose health information suggests that they would meet the eligibility inclusion criteria for a study, and not any of its exclusion criteria. Existing practices need improvement in order to become more efficient, to ensure that clinical trials can be conducted successfully in due course, and to reduce costs [8]. This can be achieved by enhancing protocol feasibility assessments for reducing the time from study design to enrollment opening, and potentially, the number of amendments downstream. ...
... Nowadays, a larger body of evidence is expected to support regulatory and evidence-based reimbursement decisions [5][6][7]. In addition to clinical efficacy and safety, there is a rising demand from regulatory authorities, health technology assessors, and payers to also generate evidence of comparative effectiveness, safety and cost-effectiveness of innovative medicines compared to current treatments, including in routine medical practice [5,8]. Hence, pharmaceutical industry needs to transform its R&D infrastructures in order to improve the efficiency of clinical research processes, reduce costs, and generate more evidence faster so to deliver effective and safe innovative medicines in a timely manner [5,9,10]. ...
... As a recent pan-European survey revealed that most clinical research stakeholders in Europe would support a value-driven innovative clinical research platform [8], this cost-benefit assessment (CBA) is the first to assess the value of the EHR4CR platform compared to current practices, from the perspective of pharmaceutical industry as primary sponsors of clinical trials in Europe and worldwide. Hence, the objective of this CBA is to assess the potential added value for the pharmaceutical industry of adopting EHR4CR solutions versus current practices, as applied to oncology clinical trials as the reference case. ...
... This scenario is used to determine the number of patients across multiple sites whose health information suggests that they would meet the eligibility inclusion criteria for a study, and not any of its exclusion criteria. Existing practices need improvement in order to become more efficient, to ensure that clinical trials can be conducted successfully in due course, and to reduce costs [8]. This can be achieved by enhancing protocol feasibility assessments for reducing the time from study design to enrollment opening, and potentially, the number of amendments downstream. ...
Article
Introduction: The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost–benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. Materials and methods: A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person–time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Results: Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5 m (S1), €45.7 m (S2), €204.5 m (S1 + S2), €1906 m (S3), and up to €2121.8 m (S1 + S2 + S3) when the scenarios were used sequentially. Conclusions: The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond.
... The potential gains in efficiency and effectiveness for primary care when obtained by rapid and secure access to patient healthcare data in electronic form are widely recognized today across the EU. Providing an interoperability infrastructure for EHRs is on the agenda of many regional, pan-European and international eHealth initiatives [1][2][3], while about half of the member states are currently working on national eHealth infrastructures. ...
... reference ontologies and mediation, have proven to be able to have significant potential as regards the integration of information from distributed EHR databases. The semantic interoperability of patient data between EHRs and medical research can transform today's process of drug discovery, development and commercialization, enable faster access for patients to effective new medications, provide improved patient outcomes, improve medication security and signal detection, and provide a key foundation for targeted personalized medicines [2,[4][5][6]. Furthermore, eHealth research during the last few years does not focus on healing, but rather proactively acting and keeping citizens healthy. ...
Article
Full-text available
Electronic Health Records (EHRs) contain an increasing wealth of medical information. When combined with molecular level data, they enhance the understanding of the underlying biological mechanisms of diseases, enabling the identification of key prognostic biomarkers to disease and treatment outcomes. However, the European healthcare information space is fragmented due to the lack of legal and technical standards, cost effective platforms, and sustainable business models. There is a clear need for a framework facilitating the efficient and homogenized access to anonymized distributed EHRs, merged from multiple data sources into a single data analysis space. In this paper we present the outcomes of Linked2Safety, a project that proposes a solution to these problems by providing a semantically interconnected approach to sharing aggregate data in the form of data cubes. This approach eliminates the risks associated with sharing pseudoanonymized (and therefore still personal) data while enabling the multi-source, multi-type analysis of health data through a single web based secure access platform. The Linked2Safety system is evaluated by external to the project Medical science analysts, Analytic methodology engineers and Data providers with respect to five specific dimensions of the system (analysis space, linked data space, usability of the system, legal and ethical issues, and value of the system) in this paper. For all five dimensions that were examined, the participants’ perceptions were overwhelmingly positive.
... Richard Perkins (eClinical Forum; Friesenheim, France) and Töresin Karakoyun (Coordination Centre for Clinical Trials; Düsseldorf, Germany) demonstrated EHR4CR [15,16] an EU-funded project that develops a platform to support clinical trials by using patient data from hospitals. Increased investments in R&D have become necessary because of a growing number of endpoints and necessary patients that leads to more complex clinical trials. ...
Article
Report about the "3rd Annual Data Management in Clinical Trials", Vienna, Austria, 19–20 February 2014. Data management in clinical trials is changing rapidly, moving towards eClinical Trials. eSource data are gaining in importance and primary care data, as well as hospital data, are being used to support patient recruitment and data collection. Here, the two EU projects TRANSFoRm and EHR4CR offer software solutions. Risk-based and remote monitoring is complementing the data collection process. Increasingly operational data are collected in addition to clinical data to improve quality control and trial supervision. But the most important aspect is the comprehensive implementation of standards. Here, the conference provided strategies to deal with the introduction of standardization, especially for the integration of diverse data sources into the clinical trials process.
... The Congressional Budget Office estimates that 90 % of physicians and 70 % of hospitals in the US will have electronic health records by 2019 [4]. Although electronic health records are primarily intended to support patient care, there is a high level of interest in using EHR data for secondary purposes such as biomedical and outcomes research, clinical process improvement, and epidemiological monitoring [5][6][7][8]. Despite some differences in EHR data quality compared to expert review and self-reported data [9], many health services researchers consider the EHR record to be more accurate compared to claims data and are calling for a shift away from claimsbased measures to using clinical measures derived from the EHR [3,10] for research, quality measurement, and performance monitoring. ...
Article
Full-text available
Background: The growing availability of electronic health records (EHRs) in the US could provide researchers with a more detailed and clinically relevant alternative to using claims-based data. Methods: In this study we compared a very large EHR database (Health Facts©) to a well-established population estimate (Nationwide Inpatient Sample). Weighted comparisons were made using t-value and relative difference over diagnoses and procedures for the year 2010. Results: The two databases have a similar distribution pattern across all data elements, with 24 of 50 data elements being statistically similar between the two data sources. In general, differences that were found are consistent across diagnosis and procedures categories and were specific to the psychiatric-behavioral and obstetrics-gynecology services areas. Conclusions: Large EHR databases have the potential to be a useful addition to health services researchers, although they require different analytic techniques compared to administrative databases; more research is needed to understand the differences.
... Eventually, better, faster and less costly feasibility studies lead to a better success rate of clinical trials [7]. Several experts agree on the need for improvement of the protocol feasibility phase, and even categorize it as one with the greatest potential for improvement [8]. ...
Article
Full-text available
Background: With the increase of clinical trial costs during the last decades, the design of feasibility studies has become an essential process to reduce avoidable and costly protocol amendments. This design includes timelines, targeted sites and budget, together with a list of eligibility criteria that potential participants need to match. The present work was designed to assess the value of obtaining potential study participant counts using an automated patient count cohort system for large multi-country and multi-site trials: the Electronic Health Records for Clinical Research (EHR4CR) system. Methods: The evaluation focuses on the accuracy of the patient counts and the time invested to obtain these using the EHR4CR platform compared to the current questionnaire based process. This evaluation will assess the patient counts from ten clinical trials at two different sites. In order to assess the accuracy of the results, the numbers obtained following the two processes need to be compared to a baseline number, the "alloyed" gold standard, which was produced by a manual check of patient records. Results: The patient counts obtained using the EHR4CR system were in three evaluated trials more accurate than the ones obtained following the current process whereas in six other trials the current process counts were more accurate. In two of the trials both of the processes had counts within the gold standard's confidence interval. In terms of efficiency the EHR4CR protocol feasibility system proved to save approximately seven calendar days in the process of obtaining patient counts compared to the current manual process. Conclusions: At the current stage, electronic health record data sources need to be enhanced with better structured data so that these can be re-used for research purposes. With this kind of data, systems such as the EHR4CR are able to provide accurate objective patient counts in a more efficient way than the current methods. Additional research using both structured and unstructured data search technology is needed to assess the value of unstructured data and to compare the amount of efforts needed for data preparation.
Article
Background Even though clinical trials are indispensable for medical research, they are frequently impaired by delayed or incomplete patient recruitment, resulting in cost overruns or aborted studies. Study protocols based on real-world data with precisely expressed eligibility criteria and realistic cohort estimations are crucial for successful study execution. The increasing availability of routine clinical data in electronic health records (EHRs) provides the opportunity to also support patient recruitment during the prescreening phase. While solutions for electronic recruitment support have been published, to our knowledge, no method for the prioritization of eligibility criteria in this context has been explored. Methods In the context of the Electronic Health Records for Clinical Research (EHR4CR) project, we examined the eligibility criteria of the KATHERINE trial. Criteria were extracted from the study protocol, deduplicated, and decomposed. A paper chart review and data warehouse query were executed to retrieve clinical data for the resulting set of simplified criteria separately from both sources. Criteria were scored according to disease specificity, data availability, and discriminatory power based on their content and the clinical dataset. Results The study protocol contained 35 eligibility criteria, which after simplification yielded 70 atomic criteria. For a cohort of 106 patients with breast cancer and neoadjuvant treatment, 47.9% of data elements were captured through paper chart review, with the data warehouse query yielding 26.9% of data elements. Score application resulted in a prioritized subset of 17 criteria, which yielded a sensitivity of 1.00 and specificity 0.57 on EHR data (paper charts, 1.00 and 0.80) compared with actual recruitment in the trial. Conclusion It is possible to prioritize clinical trial eligibility criteria based on real-world data to optimize prescreening of patients on a selected subset of relevant and available criteria and reduce implementation efforts for recruitment support. The performance could be further improved by increasing EHR data coverage.
Article
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70 www.samedanltd.com Today, many, if not all, pharma companies have put personalised healthcare (PHC) on their strategic agenda. A simplified strategic model for succeeding in PHC consists of three drivers: biological/science (including the delivery of registration-ready diagnostics and surrogate biomarkers); information management (including health information technology, and advanced capabilities to reuse large amounts of health information, as well as electronic health records (EHR)); and healthcare collaboration (including new partnerships and business models with healthcare actors). Within pharma a dominant focus for supporting PHC is on biological/science driven capabilities. The fast paced information landscape offers entirely new opportunities of reusing health information (for example, EHRs and real evidence data) not only for pharmaceuticals and biotechnology, but also to bridge and connect with healthcare, in dealing with cost pressure and consolidation, as well as the break up of value chains and disruptive transitions of core underlying technologies. As the financial implications of realising PHC are significant, the healthcare collaboration driven aspect is highly important for partnering in order o achieve personalised medicine. Therefore, if pharma is going to be able to transform itself within three to five years – combining a higher output of new molecular entities (NMEs) that are more tailored to patients, as well as a sustainable cost model for late Phase 3 studies – they will have to quickly align all three areas to create the necessary synergies to make PHC a reality.
Article
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Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.
Article
The adoption of electronic health records (EHRs) offers the potential to improve the delivery, quality, and continuity of clinical care, but widespread use has not yet occurred. In this article, we describe our use of clinical (production) data that were derived from outpatient and inpatient visits at a university teaching hospital for clinical research, a use for which the data and their structure were not originally designed. Similar data exist at many outpatient and inpatient clinical facilities, and we believe that our insights are relevant to electronically captured medical data regardless of their origin. We describe the approaches taken to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA) and to leverage the vast stores of structured and unstructured data that are currently underused. We conclude by reflecting on what we would have done differently and by making recommendations to streamline the process.
The cost of clinical trials, Drug Discovery & Development Available at: www.dddmag.com/biomarkers-save-clinical-trial.aspx
  • P Webster
Webster P, The cost of clinical trials, Drug Discovery & Development, 2005, May 18. Available at: www.dddmag.com/biomarkers-save-clinical-trial.aspx (accessed December 2, 2011).
The Pharmaceutical Industry in Figures. Key Data
EFPIA, The Pharmaceutical Industry in Figures. Key Data 2009. Update. 1-27.
Study Participant Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia, Business Insights
  • Parexel Bio
Parexel Bio/Pharmaceutical Statistical Sourcebook 2008/2009. 4. Study Participant Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia, Business Insights, June 2007.
Investigational Site Perspectives on Clinical Trial Information Systems, eClinical Forum Available at: www.eclinicalforum.org
  • Edc Site
  • Survey
EDC Site Survey: Investigational Site Perspectives on Clinical Trial Information Systems, eClinical Forum 2009. Available at: www.eclinicalforum.org (accessed December 1, 2011).
The added value of electronic health records (EHRs): Linking patient care, clinical research and public health Available at: www.eurorec.org/ files/filesPublic
  • Eu
EU: The added value of electronic health records (EHRs): Linking patient care, clinical research and public health, 2008. Available at: www.eurorec.org/ files/filesPublic/High_Level_Statement_EHR%20in% 20EU__FINAL%20_July%2014.pdf (accessed December 1, 2011).
Available at: www.himssanalytics.org/stagesGraph.asp
HIMSS Analytics Database 2001. Available at: www.himssanalytics.org/stagesGraph.asp (accessed December 1, 2011).
Available at: www.dddmag.com/biomarkers-save-clinical-trial.aspx
  • P Webster
Webster P, The cost of clinical trials, Drug Discovery & Development, 2005, May 18. Available at: www.dddmag.com/biomarkers-save-clinical-trial.aspx (accessed December 2, 2011).