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Iranian Registry of Clinical Trials: path and challenges from conception to a World Health Organization primary register
Abstract
Following the reforms in 1985 in which medical education was integrated into the National Health Service, we have witnessed an increase in teaching, training, and research capacity, improvement in quality of services, and a major boost in medical research in Iran. Following the surge in research activity, the need for public registration of clinical trials was raised within academic circles, particularly after the initiative by the International Committee of Medical Journal Editors in 2004.
In line with this global movement, the Iranian Registry of Clinical Trials was developed by a team of Iranian researchers with support from the Ministry of Health and Medical Education.
In our experience, the challenges for developing a national registry for clinical trials are: (i) choosing a committed, versatile leader with the skills and expertise to work and communicate with a variety of stakeholders and other people involved in the process; (ii) securing the necessary resources and political support to minimize resistance and act as a positive force for implementing changes; (iii) developing strong liaison between the information technology team and website administrators to develop a highly functioning website; and (iv) developing the culture of transparency within society in general, and the research community in particular, which goes far beyond setting up a registry.
The Iranian Registry of Clinical Trials has made a good start, and should fulfill its mission of providing an accessible source of information for the general public and researchers. This is the goal we have set ourselves.
... Regarding Iran' s advances in research ethics, the literature shows that not only Iran has significantly progressed in terms of the development of national medical and biomedical research ethics guidelines and has promoted their use through training and by introducing regulations but also research ethics of a diverse range of specific issues have been discussed by Iranian scholars over the past years. For example, ethical aspects of involving Iranian female participants [38]; ethical evaluation of research projects that are funded by international organizations [48]; ethical issues in clinical trials [49]; or research on laboratory animals [50,51] are all discussed elaborately in the literature. ...
... The information summarized here (shown in Figure 1) are from the sources that had appropriately described the figures. The number of faculty members in the universities and/or research centers affiliated with MOHME had increased from 3153 in 1985 [49] to 8625 in 1999 [83], 11 324 in 2007 [31], and over 13 200 by 2014 [15]. It was mentioned that in 1999, there were also 1158 faculty members in the universities outside the structure of MOHME [83]. ...
... It was reported that because of the significant increase in university admissions in the 1980s, initially, the ratio of students to faculty members had increased [86]. Later on, consequent to the development of postgraduate programs, the number of individuals who were qualified as faculty members also increased, so that the ratio relatively improved [49,86]: from 17.1 students per faculty member (in 1985) to 8 in more recent years [83,86]. Finally, the number of employed researchers in research centers affiliated to MOHME has risen from 637 in 2001, then 3828 in 2010, to reach 5736 in 2014. ...
Background:
A substantial growth has been reported in Iran's health research output over the last recent decades, throughout the times of economic, social, and political instability. This study reviewed the existing literature to provide a better understanding of the evolution of Iran's health research system over this period.
Methods:
A narrative review of studies addressing health research system (HRS) in Iran was performed. The search strategy and categorization of the retrieved data was informed by the HRS framework of the World Health Organization (WHO). This framework proposes four functions for HRS: (i) stewardship; (ii) financing; (iii) creating and sustaining resources; and (iv) producing and using research. Searches in MEDLINE through PubMed (using MeSH terms) complemented with semantic searches through PubMed and Google Scholar were conducted.
Results:
After removing the duplicates, 805 articles were retrieved, of which 601 were irrelevant, and 204 were reviewed.
Conclusions:
Iran has made substantial progress in different components of its HRS over the last few decades, such as starting a discourse surrounding health research ethics, priority-setting, and placing monitoring mechanisms while increasing the capacity for conducting and publishing research. However, there is still room for improvements, or even a need for fundamental changes, in several components, such as regarding increasing the research budget and improving the funding allocation mechanisms; improving the education curriculum; and promoting the use of evidence. The findings emphasized that improvement of HRS functions requires addressing context-specific problems. This review provides essential lessons to share with other low- and middle-income countries and international organizations, eg, the WHO.
... Sri Lanka is a developing middle-income country, and funding and technical capacity are obvious concerns for the SLCTR which have already been described. (1,2) But they are not the only constraints faced by a fledgling trial registry in a developing country (4,5). Political commitment for the process of registration is essential (5). ...
... (1,2) But they are not the only constraints faced by a fledgling trial registry in a developing country (4,5). Political commitment for the process of registration is essential (5). The SLCTR has been fortunate in this respect, with the Ministry of Health fully supporting it from its inception. ...
The Sri Lanka Clinical Trials Registry (SLCTR) is a Primary Registry in the Registry Network of the World Health Organization's International Clinical Trials Registry Platform (WHO-ICTRP), and regularly feeds data to its Clinical Trials Search Portal. Over the last few years, the SLCTR has been able to achieve its original objective of providing a national trial register for Sri Lankan researchers, but it has always been more than that of a mere storehouse of trial data. The research landscape is rapidly changing in Sri Lanka, and the SLCTR has been a key stimulus to a resurgent interest in clinical research among the Sri Lankan research community. The SLCTR is working together with its partner stakeholders to facilitate research in the country, and to ensure that clinical trials conducted in Sri Lanka meet the highest ethical and scientific standards.
... presenting 27 096 trials recorded in the ICTRP database ( Figure 2). In 2009, a review identified IRCT as WHO's primary register (Solaymani-Dodaran et al., 2009). Since then, other reviews have noted a substantial and continuous rise in the number of registered trials due to well-implemented registration policies (Solaymani-Dodaran et al., 2011;Ali et al., 2019). ...
Introduction: Clinical trials are the gold standard for testing new therapies. Databases like ClinicalTrials.gov provide access to trial information, mainly covering the US and Europe. In 2006, WHO introduced the global ICTRP, aggregating data from ClinicalTrials.gov and 17 other national registers, making it the largest clinical trial platform by June 2019. This study conducts a comprehensive global analysis of the ICTRP database and provides framework for large-scale data analysis, data preparation, curation, and filtering.
Materials and methods: The trends in 689,793 records from the ICTRP database (covering trials registered from 1990 to 2020) were analyzed. Records were adjusted for duplicates and mapping of agents to drug classes was performed. Several databases, including DrugBank, MESH, and the NIH Drug Information Portal were used to investigate trends in agent classes.
Results: Our novel approach unveiled that 0.5% of the trials we identified were hidden duplicates, primarily originating from the EUCTR database, which accounted for 82.9% of these duplicates. However, the overall number of hidden duplicates within the ICTRP seems to be decreasing. In total, 689 793 trials (478 345 interventional) were registered in the ICTRP between 1990 and 2020, surpassing the count of trials in ClinicalTrials.gov (362 500 trials by the end of 2020). We identified 4 865 unique agents in trials with DrugBank, whereas 2 633 agents were identified with NIH Drug Information Portal data. After the ClinicalTrials.gov , EUCTR had the most trials in the ICTRP, followed by CTRI, IRCT, CHiCTR, and ISRCTN. CHiCTR displayed a significant surge in trial registration around 2015, while CTRI experienced rapid growth starting in 2016.
Conclusion: This study highlights both the strengths and weaknesses of using the ICTRP as a data source for analyzing trends in clinical trials, and emphasizes the value of utilizing multiple registries for a comprehensive analysis.
... We then verified ClinicalTrails.gov [54] and IRTC [55] to identify drugs that weren't listed yet on Drug-Bank. Of the 130 drugs we identified in our analyses, 23 have been investigated in clinical trials. ...
To better understand the potential of drug repurposing in COVID-19, we analyzed control strategies over essential host factors for SARS-CoV-2 infection. We constructed comprehensive directed protein–protein interaction (PPI) networks integrating the top-ranked host factors, the drug target proteins and directed PPI data. We analyzed the networks to identify drug targets and combinations thereof that offer efficient control over the host factors. We validated our findings against clinical studies data and bioinformatics studies. Our method offers a new insight into the molecular details of the disease and into potentially new therapy targets for it. Our approach for drug repurposing is significant beyond COVID-19 and may be applied also to other diseases.
... The double-blind randomised control trial (RCT) was conducted at Kulsum International Hospital, Islamabad, Pakistan, from July 31 to October 30, 2018. It was registered with the Iranian Registry of Clinical Trials (IRCT20180417039344N1). 8 After approval from the institutional ethics review committee, the sample size was estimated using an online calculator (ClinCalc.com) 9 with power 0.80, alpha level 0.05 and mean values taken from matching literature. ...
Objective: To determine the effects of Wii Fit exer-gaming on balance confidence, quality of life and fall risk in
elderly population.
Method: The double-blind randomised control trial was conducted at Kulsum International Hospital, Islamabad,
Pakistan, from July 31 to October 30, 2018, and comprised vitally stable, physically independent subjects of either
gender aged 60 years and above, having no serious systemic disease. The subjects were randomly allocated into
experimental group A and control group B using the concealed envelope method. After baseline assessment, group
A received Wii fit gaming, while group B received balance training for 30 minutes twice a week for 8 weeks. Activities
balance confidence (ABC), European Quality of Life-5 Dimensions (EQ-5D-5L), timed up and go (TUG) and Fukuda
were used to assess the impact of the intervention. Data was analysed using SPSS 21.
Results: Of the 90 subjects, 83(92.2%) completed the study. There were 51(62%) males and 32 (38%) females; and
45(50%) in each of the two groups. Group A had 42(50.6%) subjects with 26(62%) males and 16(38%) females, and
41 were in group B, with 25(61%) males and 16(39%) females. Balance confidence improved in both groups, but it
was significantly higher in group A (p<0.001). Mobility, self-care, usual activities, pain/discomfort,
anxiety/depression as well as timed up and go and Fukuda showed significantly more improvement in group A
compared to group B (p<0.05).
Conclusion: Wii fit was found to have the potential to improve balance confidence and quality of life, reducing the
fall risk among the elderly.
Clinical Trial Number: IRCT20180417039344N1 by Iranian Registry of Clinical Trials.
Keywords: Balance training, Elderly, Exer-gaming, Quality of life, Wii fit. (JPMA 71: 2130; 2021)
... We then verified ClinicalTrails.gov [61], but also IRTC [62] to identify drugs that weren't listed yet on DrugBank. Of the 130 drugs we identified in our analyses, 23 have been investigated in clinical trials. ...
To better understand the potential of drug repurposing in COVID-19, we analyzed control strategies over essential host factors for SARS-CoV-2 infection. We constructed comprehensive directed protein-protein interaction networks integrating the top ranked host factors, drug target proteins, and directed protein-protein interaction data. We analyzed the networks to identify drug targets and combinations thereof that offer efficient control over the host factors. We validated our findings against clinical studies data and bioinformatics studies. Our method offers a new insight into the molecular details of the disease and into potentially new therapy targets for it. Our approach for drug repurposing is significant beyond COVID-19 and may be applied also to other diseases.
... could be partly explained by their source of funding (11). Following the 1985 integration of medical education into the National Health Service of Iran, there was a rapid increase in the number of public universities and postgraduate students over the decade after, resulting in a surge in the number of investigator-initiated trials (12). The number of international pharmaceutical industry-sponsored trials, however, has been limited due to sanctions and the domestic pharmaceutical companies have only recently started contributing substantially to this area. ...
... could be partly explained by their source of funding (11). Following the 1985 integration of medical education into the National Health Service of Iran, there was a rapid increase in the number of public universities and postgraduate students over the decade after, resulting in a surge in the number of investigator-initiated trials (12). The number of international pharmaceutical industry-sponsored trials, however, has been limited due to sanctions and the domestic pharmaceutical companies have only recently started contributing substantially to this area. ...
Background: Iranian Registry of Clinical Trials (IRCT) started as a primary registry in 2008. We examined the characteristics and scientometric measures of prospectively registered clinical trials in IRCT over time and compared them with that of ClinicalTrials.gov.
Methods: We selected eligible trial records between 2008 and 2016 from the IRCT database. We assessed their characteristics and the journal metrics of ensuing outputs over the study period and compared our findings with the corresponding information from ClinicalTrials.gov reported by Magdalena Zwierzyna et al. and a random sample of trials registered with this registry. We used the chi-square test for comparison of proportions and Mann-Whitney U test for comparison of medians. P-value <0.05 was considered statistically significant. Statistical analyses were performed using IBM SPSS Statistics V.22.
Results: 1751 prospectively registered clinical trials were eligible for analysis, of which 1526 (87%) had parallel-group design, 1541 (88%) reported to be randomized, 753 (43%) used double-blinding design, 485 (%27.7) had sample size more than 100, 1313 (75%) completed within a year, 1539 (87.9%) were single centered and 1529 (87.3%) exclusively used public money. Comparison with ClinicalTrials.gov showed that they are less likely to have multiple centers, funded by private sectors, continue beyond one year; and more likely to be randomized, double-blind and get published as a paper. The sample sizes were similar. Journal scientometric measures remained constant over the study period for both databases but were higher in ClinicalTrials.gov (median SJR=1.67, IQR=1.1-3.23) compared with IRCT (median SJR=0.58, IQR=0.34-0.91).
Conclusion: Our findings suggest that clinical trials registered in IRCT are predominantly investigator-initiated studies with acceptable methodological features and high publication rate albeit in journals with substantially lower scientometric measures compared with that of ClinicalTrials.gov. Journal metric indices remained constant despite an increase in the number of registrations in IRCT.
Keywords: Scientometric measures, Clinical trials, IRCT, Characteristics
... Regarding all this, developing ethical standards for improving hospital ethics seems to be crucial. In Iran there is a good communication between health system hospitals and medical schools (26,27). ...
The application of organizational ethics in hospitals is one of the novel ways to improve medical ethics. Nowadays achieving efficient and sufficient ethical hospital indicators seems to be inevitable. In this connection, the present study aims to determine the best indicators in hospital accreditation.
69 indicators in 11 fields to evaluate hospital ethics were achieved through a five-step qualitative and quantitative study including literature review, expert focus group, Likert scale survey, 3 rounded Delphi, and content validity measurement. Expert focus group meeting was conducted, employing Nominal Group Technique (NGT). After running NGT, a three rounded Delphi and parallel to Delphi and a Likert scale survey were performed to obtain objective indicators for each domain. The experts were all healthcare professionals who were also medical ethics researchers, teachers, or PhD students. Content validity measurements were computed, using the viewpoints of two different expert groups, some ethicists, and some health care professionals (n=46).
After conducting NGT, Delphi, Likert survey, 11 main domains were listed including: Informed consent, Medical confidentiality, Physician-patient economic relations, Ethics consultation policy in the hospital, Ethical charter of hospital, Breaking bad medical news protocol, Respect for the patients' rights, Clinical ethics committee, Spiritual and palliative care unit programs in the hospitals, Healthcare professionals' communication skills, and Equitable access to the healthcare. Also 71 objective indicators for these 11 domains were listed in 11 tables with 5 to 8 indicators per table. Content Validity Ratio (CVR) measurements were done and 69 indicators were highlighted.
The domains listed in this study seem to be the most important ones for evaluating hospital ethics programs and services. Healthcare organizations' accreditation and ranking are crucial for the improvement of healthcare services. Ethics programs would also motivate hospitals to improve their services and move towards patients' satisfaction. In this regard, more involvement of bioethicists can help healthcare organizations to develop ethics programs and ensure ethics-based practice in hospitals.
... Number of clinical trials (CTs) conducted in Iran has increased during the past few years (1,2). Of total 10,550 projects conducted in medical re- search in 2011, 1027 clinical trial files have been reviewed in local and national Ethics Committees (3) and some 1147 CTs have been registered in Iranian Registry of Clinical Trials (IRCT) from a total number of 2951 CTs from 2008 to date (4). ...
Clinical Trial Committee (CTC) has been established in Food and Drug Organization (FDO), in 2003 to assure efficacy and safety of all types of medicinal products which are meant to be registered in Iran Drug List and/or obtain market authorization.
All clinical trial files, meeting minutes and databases in CTC secretariat in FDO were reviewed. Relevant information and data extracted, analyzed and reported.
Total number of clinical trial (CT) files received by CTC, in 2011, was 76 cases: 21 CT protocols, 45 CT reports and 10 requests for importation of investigational new medicinal products (IMPs). Number of CT files received for herbal and natural products was 8 cases while CT files reviewed for vaccines and biological products was 50; 66% of all CT files received. Local industries sponsored 28 CT studies while 47 studies were supported by multinational/foreign companies. Of all CT files reviewed, 54 cases accounted for phase III CTs and 20 cases for phase IV and periodic safety updated reports (PSUR). With respect to the decisions made by CTC in 2011, 23 out of 45 CT reports were approved and the number of clinical trial authorizations (CTA) issued were 11; 52% of all CT protocols reviewed.
Results presented in this report are indicative of a positive trend in compliance of pharmaceutical industries and clinical research groups to national regulations of CTs and IR-GCP. Effective communication with different parties involved in regulatory and industry sides of CTs will further enhance conducting quality CTs.
... Today the ICTRP provides free access via a single web portal to more than 120,000 records of registered trials made available by clinical trial registries around the world [11]. In the intervening years the number of countries and agencies that have created and implemented their own policies on trial registration has increased, including the World Medical Association which now explicitly states in the Declaration of Helsinki that prospective registration is an ethical requirement [6,12131415161718192021222324. Prospective registration can only contribute to the more ethical conduct of clinical trials however, if all of the key information about the trial is registered, and the registered data are meaningful. ...
Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials.
A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame.
Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.
Objectives
We sought to examine the prevalence of prospective registration and publication rates in digital health trials.
Materials and Methods
We included 417 trials that enrolled participants in 2012 and were registered in any of the 17 WHO data provider registries. The evaluation of the prospective trial registration was based on the actual difference between the registration and enrollment dates. We identified existing publications through an automated PubMed search by every trial registration number as well as a pragmatic search in PubMed and Google based on extracted metadata from the trial registries.
Results
The prospective registration and publication rates were at (38.4%) and (65.5%), respectively. We identified a statistically significant ( p < 0.001) “Selective Registration Bias” with 95.7% of trials published within a year after registration, were registered retrospectively. We reported a statistically significant relationship ( p = 0.003) between prospective registration and funding sources, with industry-funded trials having the lowest compliance with prospective registration at (14.3%). The lowest non-publication rates were in the Middle East (26.7%) and Europe (28%), and the highest were in Asia (56.5%) and the U.S. (42.5%). We found statistically significant differences ( p < 0.001) between trial location and funding sources with the highest percentage of industry-funded trials in Asia (17.4%) and the U.S. (3.3%).
Conclusion
The adherence of investigators to the best practices of trial registration and result dissemination is still evolving in digital health trials. Further research is required to identify contributing factors and mitigation strategies to low compliance rate with trial publication and prospective registration in digital health trials.
According to the statement from the International Committee of Medical Journal Editors, the registration of clinical trials is needed for publishing of clinical trials. The purpose of this study was to determine the status of clinical trials registry in Iranian journals indexed in international indexes. The first issue of 93 journals was reviewed in 2012. Journals' Author guidelines were reviewed for the statements regarding the trial registration. The mentioned statement was found in 44 (44.1%) journals. While there were 9 clinical trials in these journals, only 5 of them had trial registration code. Therefore, this issue should be considered more seriously by Iranian journal editors.
According to the statement from the International Committee of Medical Journal Editors, the registration of clinical trials is needed for publishing of clinical trials. The purpose of this study was to determine the status of clinical trials registry in Iranian journals indexed in international indexes. The first issue of 93 journals was reviewed in 2012. Journals’ Author guidelines were reviewed for the statements regarding the trial registration. The mentioned statement was found in 44 (44.1%) journals. While there were 9 clinical trials in these journals, only 5 of them had trial registration code. Therefore, this issue should be considered more seriously by Iranian journal editors.
Iranian Registry of Clinical Trials (IRCT) commenced its activities as a member of WHO registry network on fourth of December 2008. We explored the progress it has made within its first four years both in terms of quantity of registrations as well as its timeliness.
We downloaded all the approved trial records until 22nd of September 2012 from the registry website. The number of registrations per calendar year was calculated and plotted over time. We assessed the timing of the registrations by categorizing them according to the date of registration in relation to the start date of recruitment into prospective, borderline prospective, borderline retrospective, and retrospective. We looked at the trends of timeliness of the registrations over time both according to registration year and the year that the recruitment had started.
There were 3145 valid registrations in IRCT until 22nd of September 2012. The number of trials increased steadily over the years from 26 in the last three months of 2008 and 182 in 2009 to 771 and 1138 in 2010 and 2011 respectively and is expected to reach 1310 in 2012. Among the 182 registrations that took place in 2009, only 16 % were prospective or borderline prospective while this figure was doubled in 2012. When we categorized registrations according to the year of recruitment, the increasing trend was more marked from 5 % and 15 % in 2009 and 2010 to 27 % and 62 % in 2011 and 2012.
IRCT has made an outstanding progress within four years from its establishment both in terms of quantity and timeliness. Registration movement has succeeded in getting the message across to the research community and clinical trial registration has now become an integral part of research sphere in Iran.
The Iranian Registry of Clinical Trials (IRCT) was established as a primary registry on December 4 2008 and has registered over 1350 trials by June 2011. Many researchers are still unaware of the need for registration of trials before recruiting the first patient and the proportion of retrospectively registered trials is likely to grow until this awareness increases. We sought to investigate the timing of the registrations in IRCT and to explore strategies to overcome this. We used all data in the IRCT database and extracted the date of registration, as well as the dates for the start and the end of recruitment. We categorized trials into 4 groups: those registered before the start of patient enrolment, within 30 days of enrolment, after 30 days but before the end of recruitment, and after the end of recruitment. The proportion of trials in each category was calculated by calendar year.
The number of registered trials increased from 26 in the 3 months leading to 2009 to 181 in 2009, 772 in 2010 and 376 in the first 5 months of 2011 (estimate by end of year = 947). The proportions of trials registered after the end of patient recruitment were 55%, 58% and 62% in 2009, 2010 and 2011 respectively. On average, 6.4% of trials were registered within 30 days from the start of patient recruitment and 27% in the time between then and the end of recruitment.
The rapid increase in the number of registered trials is an indication of strong implementation of the registration policy. This comes partly at the expense of an increased proportion of retrospective registrations. While this may be understandable at the beginning, it is clearly not acceptable and measures should be adopted to increase the proportion of prospectively registered trials and to make trial registration an integral part of the research culture.
In the 4 years between the Ministerial Forums on research and health held in Mexico in 2004 and Mali in 2008, the landscape of clinical trial registration changed significantly. When the ICMJE announced that they would no longer consider publishing the findings of clinical trials unless the research had been prospectively registered, they were key to shifting the way the clinical trials community thinks about research transparency. The argument in favour of greater transparency had been building for more than 20 years. By 2004 there was consistent and convincing evidence of the existence of publication bias and the damage this does to people's ability to make well informed decisions about health care. There is now increasing acceptance that the registration of clinical trials in a publicly accessible registry is a scientific, ethical and moral responsibility. In 2004, less than 3000 clinical trials were registered on databases meeting ICMJE criteria. There are now more than 19000 and, in some countries, prospective registration in a publicly accessible registry is now a legal requirement. Further, since October 2008, prospective registration is required if researchers wish to comply with the Declaration of Helsinki. However, despite these advances and incentives, trial registration in many countries remains far from comprehensive and stronger enforcement mechanisms may be needed in those countries.
In September 2004, the International Committee of Medical Journal Editors (ICMJE) published a joint editorial to promote registration of all clinical trials. We stated that we will consider a trial for publication only if it has been registered before the enrollment of the first patient. As our deadline for registration approaches, trial authors and sponsors want to be sure that they understand our requirements. The purpose of this joint editorial is to answer questions about the ICMJE initiative and to bring our position into harmony with that of others who are working toward the same end.
In this editorial, published simultaneously in all member journals, the International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness of clinical trials. The Committee announces that all 11 ICMJE member journals will adopt a trials-registration policy that promotes this goal.
Altruistic motives and trust are central to scientific investigations involving people. These prompt volunteers to participate in clinical trials. However, publication bias and other causes of the failure to report trial results may lead to an overly positive view of medical interventions in the published evidence available. Registration of randomised controlled trials right from the start is therefore warranted. The International Committee of Medical Journal Editors has issued a statement to the effect that the 11 journals represented in the Committee will not consider publication of the results of trials that have not been registered in a publicly accessible register such as www.clinicaltrials.gov. Patients who voluntarily participate in clinical trials need to know that their contribution to better human healthcare is available for decision making in clinical practice.
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