Medicine

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Awareness of clinical trial registration among healthcare professionals: An observational study.
(Wiley-Blackwell, 2018) Ranawaka, U.K.; de Abrew, A.; Wimalachandra, M.; Wanigatunge, C.A.; Rajapakse, L.C.; Goonaratna, C.
AIM: Prospective registration in a freely accessible public platform is a key step in the ethical conduct of clinical trials. Little is known of the awareness of clinical trial registration among the scientific community. This study aimed to assess awareness of clinical trial registration among participants attending a medical congress in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire, which spanned domains such as involvement in research, and knowledge and perceptions regarding trial registration. A knowledge score was calculated and correlated with demographic variables. RESULTS: Of 251 survey respondents, 53.4% were male, 74.9% were below the age of 40 years, and 56.6% were currently engaged in research. Registration was considered necessary for trial publication by 73.3%, and 70.5% agreed that trials should be registered prospectively. Most achieved a knowledge score of 'Acceptable' (41%) or 'Good' (19.9%). Mid- or advanced career stages, postgraduate training, current involvement in research, and recent research publications/presentations were correlated with higher knowledge scores (P < 0.05). Beneficial effects considered to be associated with trial registration were 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 conduct (52.2%), and the possibility of 'intellectual theft' (56.2%) were seen as potential negative effects. CONCLUSIONS: Most participants were aware of the need for prospective registration as a requirement for publication of clinical trials. Concerns were expressed regarding several perceived negative effects of trial registration.
Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry
(Wiley-Blackwell, 2018) Ranawaka, U.K.; de Abrew, A.; Wimalachandra, M.; Samaranayake, N.; Goonaratna, C.
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.
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.
The Sri Lanka Clinical Trials Registry - five years young, and growing.
(Sri Lanka Medical Association, 2012) Ranawaka, U.K.; Wanigatunga, C.; de Abrew, A.; Wimalachandra, M.; Goonaratna, C.
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