ArticlePDF Available
95
Vol. 57, No. 2, June 2012
Correspondence
Introduction
The Sri Lanka Clinical Trials Registry (SLCTR) has
completed five years of existence, and we take this
opportunity to review its progress so far.
The global clinical trial regulatory landscape was
changing at the dawn of the new millennium. There was
widespread discontent over selective publication of
positive trial results and concealment of negative results,
leading to distortion of the body of evidence available for
clinical decision making [1-3]. As a result, there was a
growing call for more transparency in the conduct and
public disclosure of clinical trials [1-3]. Mandatory
registration of all clinical trials, before trial commencement
and recruitment of participants, was seen as a possible
mechanism to ensure that all trial data would be available
in the public domain, thus enabling clinicians, patients,
researchers and health care planners to make informed
choices [1-3]. The call for trial registration, which started
in the 1970s, gradually gathered momentum at the turn of
the century [4,5]. A major turning point was the publication
of two landmark articles in 2004 and 2005 by the
International Committee of Medical Journal Editors
(ICMJE), who demanded prospective registration of all
trials if they were to be considered for publication [3, 6].
The WHO strongly supported the call for mandatory trial
registration, and established the International Clinical
Trials Registry Platform (ICTRP) in 2005 to support and
coordinate global efforts on trial registration [7]. The World
Medical Association amended the Declaration of Helsinki
at its 59th General Assembly in 2008 to state that every
clinical trial must be registered in a publicly accessible
database before recruitment of the first participant [8].
Prospective registration is now a mandatory requirement
for the conduct of clinical trials.
The need for a national body for trial registration
was first highlighted in a leading article in the Ceylon
Medical Journal (CMJ) [9]. Recognising this need, the
Sri Lanka Medical Association (SLMA) appointed a
committee in August 2006 to establish and manage the
SLCTR (the SLCTR Committee), with representation from
the Ministry of Health, Postgraduate Institute of
Medicine, universities, ethics review committees and other
professional bodies. The SLCTR started functioning in
November 2006, and was the first clinical trials registry in
South Asia to commence operations. The first trial was
registered with the SLCTR in February 2007. The
establishment of the SLCTR has been described in detail
previously [10,11].
To the Editors:
The Sri Lanka Clinical Trials Registry – five years young, and growing
Ceylon Medical Journal 2012; 57: 95-96
The SLCTR was recognized as a Primary Registry by
the WHO-ICTRP in March 2008. It is a not-for-profit
registry, with free access to clinicians, patients,
researchers, health care planners, funding agencies and
the public (http://www.slctr.lk). Data of all trials registered
with the SLCTR are regularly uploaded to the ICTRP, and
are thus available to the public worldwide via the ICTRP
Clinical Trials Search Portal. Over the last five years, 68
clinical trials have been registered with the SLCTR, and
four of them were international multi-centre trials. Of these,
39 trials have been completed, and two trials have stopped
recruitment before completion. Fourteen trial applications
were not accepted for registration, with delayed application
after trial commencement being the main reason. During
this period, 15 trials conducted in Sri Lanka have been
registered with a trial registry in the WHO-ICTRP Registry
Network other than the SLCTR.
From its inception, the SLCTR has striven to meet
the stringent standards expected of an international
clinical trials registry as specified by the WHO-ICTRP,
and has continued to improve as the ICTRP requirements
have evolved over the years. It updates trial records with
progress reports and protocol changes, maintains and
updates its standard operational procedures, and carries
out internal audits of data quality and operational
processes. The website has undergone several
modifications, and is now being completely revamped.
The SLCTR is managed by the SLMA, and the
SLCTR Committee advises on operational activities and
policy matters. It works in close collaboration with the
Ministry of Health, professional organisations, ethics
review committees and other stakeholders in clinical
research. The Ministry of Health has supported the SLCTR
from its inception, and has provided the political
commitment that is vital for the success of trial registration.
Establishment of the SLCTR has, in turn, helped to improve
research transparency at a national level, and augmented
the Ministry’s efforts to ensure the conduct of ethical and
scientific research. The clinical trial landscape is changing
in Sri Lanka, with a resurgent interest in conduct of clinical
trials locally, and an influx of international collaborative
research. This has brought into focus the need for
improved ethical oversight of clinical research and better
safeguards for participants. The Ministry of Health has
taken several steps to strengthen the regulatory
mechanisms governing clinical research, and the SLCTR
has been an active participant in these initiatives.
96
Ceylon Medical Journal
Correspondence
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 [10-12], 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. This is an area
that the SLCTR has to address with more concerted effort.
Over the last five years, the SLCTR has been
successful in establishing a national platform for trial
registration in Sri Lanka. But there is much more that needs
to be done, in addition to improving research transparency.
There is a clear need to improve awareness on clinical
research, to build research capacity, and to ensure that
clinical trials conducted in Sri Lanka meet the highest
ethical and scientific standards. The SLCTR is committed
to working with its partner stakeholders to achieve these
goals, and create a research environment that the country
can be proud of.
References
1 Dickersin K, Rennie D. Registering clinical trials. Journal of
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6 De Angelis CD, Drazen JM, Frizelle FA, et al. Is this clinical
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7 International Clinical Trials Registry Platform (ICTRP).
Geneva: World Health Organization. http://www.who.int/
ictrp/about/details/en/index.html. (Accessed 12 May 2012).
8 Declaration of Helsinki. Ethical principles for medical
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10policies/b3. (Accessed 12 May 2012).
9 Goonaratna C. Mandatory registration of clinical trials.
Ceylon Medical Journal 2005; 50: 139-41.
10 Ranawaka UK, Goonaratna C. Sri Lanka Clinical Trials
Registry. Ceylon Medical Journal 2007; 52: 117-9.
11 Ranawaka UK, Goonaratna C. Establishing the Sri Lanka
Clinical Trials Registry. Journal of Evidence Based Medicine
2009; 2: 29-31.
12 Ranawaka UK, Goonaratna C. Sri Lanka Clinical Trials
Registry – moving forward. Journal of Evidence Based
Medicine 2011; 4: 179-81.
U K Ranawaka
1
, C Wanigatunga
2
, A de Abrew
3
, M Wimalachandra
3
, C Goonaratna
4
1
Faculty of Medicine, University of Kelaniya,
2
Faculty of Medical Sciences, University of Sri Jayewardenepura,
3
Faculty
of Medicine, University of Colombo, and
4
Ceylon Medical College Council, Faculty of Medicine, University of Colombo
Correspondence: UKR, e-mail: <udayaran@yahoo.com>. Received 17 May 2012 and revised version accepted 22
May 2012. Competing interests: none declared.
... The SLCTR has evolved over the years in a constant endeavour to meet the stringent standards laid down by the ICTRP, despite the many challenges posed by resource constraints inherent to a low-middle income country. The SLCTR has regularly contributed to the global literature on clinical trial registration; its progress has been well documented in the early years, 18,19 and it was the first to report the ten-year experience of a primary clinical trial registry. 20 While meeting its key obligation of providing a national platform for clinical trial registration, it has carried out many activities to improve awareness on trial registration and enhance research capacity at a national level. ...
... 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
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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.
Article
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