Browsing by Author "de Abrew, K.A.G."

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    Awareness of clinical trial registration
    (Sri Lanka Medical Association, 2012) Wimalachandra, B.C.M.; Ranawaka, U.K.; de Abrew, K.A.G.; Wanigatunga, C.A.; Rajapaksa, L.C.; Goonaratna, C.
    INTRODUCTION: Prospective registration in a freely accessible public domain is mandatory for clinical trials. Little is known regarding awareness of clinical trial registration among the scientific community. AIMS: To assess awareness of clinical trial registration among participants attending a scientific meeting in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire. Results: Only 251 out of 714 participants (35.6%) returned completed valid questionnaires. Of them, 53.4% were males, 74.9% were below the age of 40 years, and 49% had less than 5 years of professional experience. Majority (56.6%) were currently involved in research. Registration was considered necessary for trial publication by 73.3%, for presentation of findings by 56.2%, and for ethics approval by 54.6%. Over 70% agreed that trials should be registered prospectively. Majority felt it was beneficial to have research findings freely accessible to other researchers (81.3%), clinicians (84.5%) and research participants (76.7%). Many agreed on the positive effects of trial registration - access to findings of all trials (61.4%), access to negative results (47.8%), preventing trial duplication (69.3%) and preventing multiple publications (70.1%). Increasing research workload (49.8%), additional restrictions on research (52.2%) and possibility of'intellectual theft' (56.2%) were seen as potential negative effects. Awareness of access to registration mechanisms for trials conducted in Sri Lanka (49%), and a Sri Lankan trial registry (31.5%) was poor. CONCLUSIONS: Awareness of clinical trial registration was satisfactory in some aspects, but several areas need improvement.
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    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.