Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Quality of clinical trial registration at the Sri Lanka clinical trials registry: a 5-year analysis(Sri Lanka Medical Association, 2017) Ranawaka, U.K.; de Abrew, A.; Ranasinghe, R.M.A.G.; Kulathunga, K.A.C.J.; Wimalachandra, M.; Samaranayake, N.; Goonaratna, C.INTRODUCTION & OBJECTIVES: Previous studies have highlighted the poor quality of clinical trial registration in international registries. We sought to evaluate the quality of trial registration in the Sri Lanka Clinical Trials Registry (SLCTR). METHODS: We studied all trial records at SLCTR over a 5-year period (2012-2016). Records were evaluated for data quality, using pre-defined criteria, regarding the following: WHO minimum trial registration data set (WHO-TRDS), ethics review approval, and detailed analysis of contact information, interventions and outcomes. RESULTS: A total of 144 trial records were studied. All records had meaningful entries for 12 out of the 20 items in WHO-TRDS, and over 95% of records had meaningful entries for 16 items, while the mean TRDS score was 17.76 ±1.03. Details of ethics approval were provided in all records. Intervention specifics were recorded for 174 experimental or active comparator arms. Meaningful information was provided regarding intervention name, dose, duration, frequency and route in 173 (99.4%). 156 (89.7%), 123 (70.7%), 132 (75.9%) and 109 (62.6%) arms respectively. A total of 388 primary outcome measures were recorded. Of them, 79.1% (n=307) were considered to be of good quality (specific – 76%; safety monitoring – 3.1%). Recording of time frame was considered to be of good quality for 94.4% (n=366) of outcomes (meaningful – 83.8%; irrelevant – 10.6%). All records provided either email address or telephone number of contact person; 98% (n= 141) had both. CONCLUSION: Quality of clinical trial registration at the SLCTR is better compared to other international registries in almost all the domains studied. Trial registration of good quality is feasible and sustainable in a resource-limited setting.Item The Sri Lanka Clinical Trials Registry - a 5 year audit(Sri Lanka Medical Association, 2012) de Abrew, K.A.G.; Ranawaka, U.K.; Wanigatunge, C.A.; Wimalachandra, M.; Goonaratna, C.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.