Background: Empirical evidence suggests that the reporting of randomized controlled trials (RCTs) is suboptimal. Poor quality of reporting of RCTs may be due to poorly designed and conducted trials as well as to inadequacies in reporting important elements of an RCT. International efforts to improve the standards of reporting clinical trials include the CONSORT guidelines and these have been endorsed and extended by the International Committee of Medical Journal Editors (ICMJE) guidelines in their uniform requirements. However, these efforts may be inadequate if reference to these initiatives occurs only at the stage of reporting results of the trial. The joint initiative of the ICMJE and the WHO International Clinical Trials Registry Platform on the prospective registration of clinical trials provides an additional opportunity to improve the design, conduct and reporting of randomized clinical trials in developing countries
Aim: To document the strategies employed by the newly formed Clinical Trials Registry-India to ensure better design, conduct and reporting of randomized clinical trials from India and the South Asian region
Methods: At the initiation of my membership to the steering committee of the Clinical Trials Registry-India (CTR-I), the following steps were taken: a) results of a survey undertaken by the South Asian Cochrane Network on inadequacies in reporting of RCTs from Indian Medical Journals were presented; b) critical elements that impact on the internal validity of RCTs were highlighted; c) recent controversies regarding the ethical conduct of RCTs from the India were highlighted; d) the imperative for the CTRI to have a mission (being compliant with the WHO ICTRP/ ICMJE requirements) as well as a vision (using trials registration to improve the design, conduct and reporting of clinical trials) was suggested; e) established trials registers were consulted and items pertaining to ethical conduct and internal validity of RCTs were ascertained; f) a draft document of suggested trial elements to be included in the register (the mandatory WHO ICTRP dataset items as well as items that improve the ethical conduct and internal validity of RCTs) was circulated among steering group members and vigorously defended at meetings with industry representatives.
Results: The above elements were incorporated in full in the CTRI. This will ensure that trialists are aware of the elements that impact on the ethical and valid design and conduct of trials. Subsequently, the CTRI and the rationale for inclusion of all data elements were presented to a meeting of medical journal editors. The need to link the CTRI with ethics committees was discussed with the Indian Council of Medical Research's national bioethics initiative. A template for submission of trial protocols to research and ethics committees was prepared, sent for publication to a leading medical journal and is being used in some institutions to reflect current international requirements of transparency as well as ethical and valid conduct of RCTs.
Conclusions: Prospectively registering clinical trials can aid better design and reporting of RCTs if the necessary elements form part of the trials register. Ongoing partnership between trials registers, medical journal editors and ethics committees is needed to ensure that all trials are fully registered. Continued audit of registered trials and comparison with published reports/unpublished results is needed to evaluate the effectiveness of this strategy.