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Establishing the Sri Lanka Clinical Trials Registry

Authors:

Abstract

Recognizing the need for a national body for trial registration, the Sri Lanka Medical Association took up the challenge of setting up the Sri Lanka Clinical Trials Registry. The registry was established in November 2006, the first functioning trial registry in South Asia. The Sri Lanka Clinical Trials Registry is now a primary registry affiliated to the Registry Network of the International Clinical Trials Registry Platform of the World Health Organization. The Sri Lanka Clinical Trials Registry has not been a mere repository for trial data but has also had a positive influence on the research community in Sri Lanka.
Journal of Evidence-Based Medicine ISSN 1756-5391
ORIGINAL ARTICLE
Establishing the Sri Lanka Clinical Trials Registry
Udaya K Ranawaka1and Colvin Goonaratna2
1Administrator and Secretary of Sri Lanka Clinical Trials Registry and Faculty of Medicine, University of Kelaniya,
Ragama, Sri Lanka;
2Chairperson of Sri Lanka Clinical Trials Registry and Faculty of Medicine,
University of Colombo, Colombo, Sri Lanka
Keywords
Clinical trial; developing countries;
publishing; Sri Lanka; trials registry
Correspondence
Udaya K Ranawaka, Faculty of Medicine,
University of Kelaniya, PO Box 6, Talagolla
Road, Ragama, Sri Lanka.
Tel: +94-11-2961119;
Fax: +94-11-2958337;
email: udayaran@yahoo.com
Received 22 December 2008; accepted for
publication 10 January 2009.
doi: 10.1111/j.1756-5391.2009.01003.x
Abstract
Recognizing the need for a national body for trial registration, the Sri Lanka Med-
ical Association took up the challenge of setting up the Sri Lanka Clinical Trials
Registry. The registry was established in November 2006, the first functioning trial
registry in South Asia. The Sri Lanka Clinical Trials Registry is now a primary reg-
istry affiliated to the Registry Network of the International Clinical Trials Registry
Platform of the World Health Organization. The Sri Lanka Clinical Trials Registry
has not been a mere repository for trial data but has also had a positive influence
on the research community in Sri Lanka.
Mandatory trial registration:
a call for greater transparency in
clinical trials
Mandatory registration of clinical trials has come to stay. Af-
ter a rather long conception and difficult labor, it has finally
seen the light of day. And it has been welcomed into the
world of clinical trials by researchers, academia, clinicians,
and even the pharmaceuticals industry, albeit after much ini-
tial skepticism. Like any success story, it has many parents.
Many isolated requests for greater transparency in clinical
trials date back to the early 1970s (1, 2). The call gath-
ered momentum with each new therapeutic mishap related
to selective reporting, and there became enough of them to
convince even the most ardent opponents (3–5). A major im-
petus, of course, came with the decision of the International
Committee of Medical Journal Editors (ICMJE) that all clin-
ical trials involving humans should be prospectively regis-
tered before they can be considered for publication (6, 7).
The World Health Organization (WHO) strongly supported
the ICMJE stance, declaring “registration of all interven-
tional trials a scientific, ethical, and moral responsibility” (8,
9). The WHO has successfully marshaled activities under the
banner of the International Clinical Trials Registry Platform
(WHO-ICTRP) (9). It has also laid the ground rules for reg-
istration by specifying the minimum criteria for a registry:
the WHO-ICTRP minimum data set.
The benefits of prospective trial registration are many (6,
9–11), and the concept has now been embraced by the sci-
entific community. It is heartening to note that the WHO has
been able to bring together different countries, and national
registries have been established in countries with different
socioeconomic backgrounds (12). The call for mandatory
trial registration has received a major boost by the recently
amended Declaration of Helsinki, stating “every clinical trial
must be registered in a publicly accessible database before
recruitment of the first subject” (13).
Sri Lanka Clinical Trials Registry:
the beginning
The Ceylon Medical Journal (CMJ) first raised the call for a
national body for trial registration in Sri Lanka in 2005 (14).
The CMJ is committed to abiding by the ICMJE guidelines in
JEBM 2(2009) 29–31 c
2009 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University 29
Sri Lanka Clinical Trials Registry UK Ranawaka and C Goonaratna
medical publishing, and in the wake of the ICMJE declaration
on trial registration (6), called upon the Sri Lanka Medical
Association (SLMA) to take up this challenge in its capac-
ity as the premiere professional medical organization in the
country. After deliberation, the SLMA decided to establish
the Sri Lanka Clinical Trials Registry (SLCTR). A committee
of academics and scientists was appointed in August 2006 to
establish and manage the SLCTR (the SLCTR Committee),
with representation from the Ministry of Health, Postgradu-
ate Institute of Medicine, universities, ethics review commit-
tees, and other professional bodies. Designing an internet-
based registry with online facilities for the submission of
trial applications, review, and registration was always going
to be an onerous task and was outsourced to the web design
team of Sri Lanka Telecom, the main telecommunications
provider in the country. The SLCTR has been operational
from November 2006, and was the first functioning clinical
trials registry in South Asia. It is a matter of pride to us that
the SLMA was able to establish a clinical trials registry in
a developing country like Sri Lanka, without any external
support. The SLCTR was recognized as a primary registry
by the WHO-ICTRP in March 2008.
SLCTR now
The SLCTR is an internet-based, not-for-profit registry pro-
viding free access to researchers, clinicians, funding agen-
cies, and the public at www.slctr.lk/. It welcomes registra-
tion of trials conducted in Sri Lanka and overseas. It has
been designed to meet the requirements specified by the
WHO-ICTRP and the ICMJE. In addition to the minimum
WHO data set, it records details of ethics review commit-
tee approval and solicits regular progress reports from in-
vestigators. The SLCTR accepts only clinical trials with a
health-related intervention and does not register observa-
tional studies. After an initial grace period where researchers
were allowed to register trials after starting recruitment, it
now accepts only prospective trial registration. All trial ap-
plications are evaluated by the SLCTR Committee, which
meets regularly. The website is currently undergoing further
development, and new features will include links to progress
reports of ongoing trials and publications for completed
trials.
Role of SLCTR in Sri Lanka
Sri Lanka is a developing country with limited resources.
It has a per capita GDP of USD 196, a per capita annual
health expenditure of USD 51, and 0.6 doctors per thousand
people (15, 16). In spite of the relative lack of resources,
it continues to be an example in terms of healthcare and
social development; its health indicators, literacy rates, and
gender equality ratios are among the best in the developing
world, especially South Asia (15, 16). The foundations of
the medical establishment are old and strong. For example,
the SLMA is the oldest professional medical association in
Australasia, and the CMJ is the oldest medical journal in
Australasia. There is a vibrant medical research culture, and
clinical trials with international collaboration are flourishing.
The SLCTR has provided local researchers with a read-
ily accessible national registry, and many trials have been
registered to date. The registry has played the key role in cre-
ating awareness of the need for trial registration, with several
presentations at scientific meetings, journal publications (11,
14), and regular updates in newsletters. However, the estab-
lishment of the SLCTR appears to have had a much more
profound impact on the research culture within the country.
It has re-invigorated discussion on clinical trials, ethics in re-
search, and research publication at scientific meetings. Most
ethics review committees in the country have started granting
only conditional approval for clinical trial applications, with
full approval subject to registration with a publicly accessible
registry.
SLCTR: challenges ahead
Funding, and therefore, staffing, are problems that the
SLCTR will continue to grapple with, as the SLMA is a not-
for-profit institution. Fortunately, the Ministry of Health and
the WHO have come forward to help ease the burden. With
the affiliation to the WHO-ICTRP as a primary registry, the
SLCTR has to develop mechanisms for uploading data to the
ICTRP. This has created a new set of challenges for the web
design team. Initial difficulties were easily forgotten amidst
the success of establishing the Registry and its recognition
as a primary registry by the WHO. Keeping the momentum
will be more difficult. Improving awareness among the scien-
tific community about trial registration needs more emphasis.
The SLCTR is determined to go forward despite these chal-
lenges, and the co-operation of clinicians, researchers, health
care planners, patients, and the public will be vital.
Conflict of interests: None.
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2009 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University 31
... The first trial was registered with the SLCTR in February 2007. The establishment of the SLCTR has been described in detail previously [10,11]. ...
... Awareness on clinical trial registration is a key ingredient for the success of the drive for prospective trial registration. The SLCTR has taken several steps to improve awareness on trial registration among the scientific community, with presentations at several scientific meetings across the country, publication of articles [10][11][12], and regular updates in newsletters of professional organizations. In addition to clinicians and researchers, patients and the public need to be aware of the concept of trial registration, and how information can be accessed on any clinical intervention. ...
... The SLCTR was recognized as a Primary Registry by the WHO-ICTRP in March 2008, being the fourth Primary Registry to join the Registry Network. 16,17 The SLCTR (http://www.slctr.lk/) is an internetbased, not-for-profit clinical trials registry, with free access to researchers, clinicians, policy makers, funding agencies and the public. It is a repository for trials conducted in Sri Lanka and overseas. ...
... The establishment of the SLCTR and its early progress have been previously described. [6][7][8][9] The SLCTR completed 10 years in November 2016, and we report our experience over this period. ...
Article
Full-text available
Aim: We describe our experience of the first 10 years at the Sri Lanka Clinical Trials Registry (SLCTR). Methods: We analyzed all trial records of the SLCTR over the study period. We collected information regarding trial characteristics and completeness of data entry in the SLCTR data set. Results: During the study period, 210 trials (63% of all applications) were registered with the SLCTR. The number of registered trials showed an increasing trend over the years. All trial registrations had complete entries for all the data fields studied. Only 17.6% of the trials were registered retrospectively. All the registered trials were interventional studies, and the majority (87.6%) were randomized controlled trials. A significant proportion of trials (28.6%) were on noncommunicable diseases, and 12.4% were on pregnancy and its outcomes. Several trials (9.5%) were international collaborative studies. A majority of the Principal Investigators (70.9%) were affiliated to a university. Most of the studies (41.9%) were self-funded by the investigators. Details of ethics review committee approval were available for 96.7% of registered trials. Over a third of the registered trials (37.1%) had completed recruitment at the time of analysis. A majority of the trials (72.8%) had updated trial data since registration. Conclusions: There is a steady increase in the number of trials registered at the SLCTR. Complete entries for all the data fields were seen in all trial registrations. The SLCTR has made a positive contribution to the emergence of a healthy clinical research environment in Sri Lanka.
... The Sri Lanka Clinical Trials Registry (SLCTR) was formed as an initiative of the Sri Lanka Medical Association (SLMA), with whole-hearted support from the Ministry of Health of Sri Lanka. Its establishment has been previously discussed in detail (1,2). It has been operational from November 2006, and was the first functioning clinical trials registry in South Asia. ...
Article
Full-text available
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.
... Returning to this issue of the Journal, we are pleased to bring you a variety of material to read and enjoy, relevant to health care and research around the world. You can find out about the establishment and growth of the Pan African Clinical Trials Registry, which is part of the World Health Organization Network of Primary Registries (4) along with registries from many other parts of the world, including China (5), Germany (6), India (7), Iran (8), Japan (9) and Sri Lanka (10). There is a systematic review including 28 papers about the effects of martial arts on health and wellbeing, and another systematic review and meta-analysis examining the role of interferon-? in HBeAg-positive chronic hepatitis B, drawing on evidence from 31 randomized trials, with more than 2000 patients. ...
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