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Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry

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dc.contributor.author Ranawaka, U.K.
dc.contributor.author de Abrew, A.
dc.contributor.author Wimalachandra, M.
dc.contributor.author Samaranayake, N.
dc.contributor.author Goonaratna, C.
dc.date.accessioned 2018-02-02T09:34:24Z
dc.date.available 2018-02-02T09:34:24Z
dc.date.issued 2018
dc.identifier.citation Journal of Evidence-based Medicine.2018 en_US
dc.identifier.issn 1756-5391 (Electronic)
dc.identifier.issn 1756-5391 (Linking)
dc.identifier.uri http://repository.kln.ac.lk/handle/123456789/18598
dc.description Indexed In MEDLINE en_US
dc.description.abstract 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. en_US
dc.language.iso en_US en_US
dc.publisher Wiley-Blackwell en_US
dc.subject Clinical trials en_US
dc.title Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry en_US
dc.type Article en_US


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