Statement on publishing clinical trials in Indian biomedical journals

摘要

The registration of clinical trials will help improve reliability of data generated, help clinicians interpret research, minimize duplication of trials and prevent exposure of volunteers to potential risks. The Clinical Trial Registry India (CTRI; www.ctri.in) hosted at the National Institute of Medical Statistics (NIMS), Indian Council of Medical Research (ICMR), New Delhi, was formally launched on July 20, 2007. This is a free online registry of clinical trials established with the aim to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset and a few additional items. Thus, the CTRI becomes a WHO's ICTRP and ICMJE compliant Primary Register for India. Clinical trial has been defined by the ICMJE.