Establishing the Sri Lanka Clinical Trials Registry

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.

Full text

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
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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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