The Sri Lanka Clinical Trials Registry - a 5 year audit

Abstract

INTRODUCTION: Prospective registration is mandatory for the conduct and publication of clinical trials. The Sri Lanka Clinical Trials Registry (SLCTRJ was established in November 2006. It is a Primary Registry of the International Clinical Trials Registry Network of the WHO. AIMS: To audit the process of trial registration at the SLCTR during the 5 year period from the first trial registration (February 2007-January 2012). Methods: An internal audit of the online registry and the functioning of the SLCTR was carried out. We evaluated- (1J all trial applications, including those rejected, for accuracy and completeness of the Trial Registration Data Set (TRDS), (2) all registered trials for maintenance of records and (3) in-house procedures related to trial registration. RESULTS: Seventy trials were registered; 14 were rejected. Over half (n=37) were prospective registrations. All registrations since July 2010 (n=21) were prospective. Four were international multi-centre trials; 13 were industry sponsored. Median time from submission of all relevant documentation to registration was 7 days. All applications from 2010 were registered within 7 working days. Majority (n=41J were drug trials, including herbal preparations (n=7), while 19 were for procedures. 39 trials have been completed, 8 have published their findings and 7 reported protocol changes. Eight trials (11.4%) do not have current progress reports. CONCLUSIONS: The SLCTR has provided a platform for registration of clinical trials in Sri Lanka. In-house registration processes have improved with time. There is a need to improve awareness among trial registrants regarding maintenance of trial records.