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Ten years of clinical trial registration in a resource‐limited setting: Experience of the Sri Lanka clinical trials registry
Author(s) -
Ranawaka Udaya K.,
Abrew Ashwini,
Wimalachandra Manu,
Samaranayake Nithushi,
Goonaratna Colvin
Publication year - 2018
Publication title -
journal of evidence‐based medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.885
H-Index - 22
ISSN - 1756-5391
DOI - 10.1111/jebm.12284
Subject(s) - clinical trial , medicine , trial registration , sri lanka , family medicine , geography , environmental planning , tanzania
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.