Prospective Registration of Clinical Trials in India: Strategies, Achievements & Challenges

Abstract

Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of existing legislative opportunities to complement these efforts.

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications

“…An earlier survey of the first 144 registered trials in the CTRI [31] revealed similar high frequencies of adequate reporting for sequence generation (83%), allocation concealment (76%), blinding and masking (85%), and ethics committee approval (100%). Such high rates of reporting for these domains are also higher than any report in trial publications assessing reporting quality worldwide and auger well for the reporting quality of future trial publications in Indian or other journals that publish their results [33].…”

“…In addition to the WHO and ICMJE mandated 20-item data set for prospective registration of trials, disclosure of the CTRI-specific items aimed at improving internal validity [31] (method of generating the randomization sequence, method of allocation concealment, and blinding or masking) were noted for each record, as was done for published reports. The CTRI-specific items of ethics committee approval and sources of funding were also noted.…”

“…Although not part of the ICMJE and WHO 20-item registration data set, these items were included to facilitate incorporating improved trial methods at the stage of protocol design [31,59] Better disclosure in registered trials of adequate methods used to minimize the risk of bias [16]. This additional specific requirement was aimed at ensuring prospective trials registration in the CTRI by industry-funded trials There has been an increase in prospective trials registration of industry-funded trials in the CTRI following the announcement of this requirement…”

“…Vision: In addition to the mandatory 20-item WHO data set required to be disclosed at registration, specific fields were created for the CTRI, some of which are mandatory for registration [31,59e61] The CTRI was designed to improve understanding in India of critical aspects of trial methods that impact on validity and based on the suboptimal results of reporting quality in published trials in Indian journals in our previous survey [23] Elements that minimize the risk of bias and improve internal validity are incorporated in the design of registered trial protocols 3. Ethical aspects: Disclosure of ethics committee details and submission of the ethics committee approval document were made mandatory for registration These were made mandatory in the CTRI to improve transparency and accountability and to facilitate ethical oversight [31,59] Ethics approval and ethics committee details are provided by all registered trials 4. Internal validity: The methods used for randomization, allocation concealment, and blinding are provided as CTRI-specific obligatory fields (with a drop-down list of options and explanations)…”

Is the practice of public or private sector doctors more evidence-based? A qualitative study from Vellore, India

“…31,37 Particularly, the regulation of the establishment and activities of private health facilities is weak; thus there are several private health facilities with differing levels of quality. 31 The reason why doctors in the public service sometimes engage in private practice is mainly financial as public service remunerations in many developing countries are insufficient.…”