Determinants of performance measures of clinical trials: a study of Indian medical devices industry

Naga Rekha Gorantla, Bala Subrahmanya Mungila Hillemane


Developing new medical devices require extensive clinical investigations to enter the market successfully. In recent years, India has emerged as one of the attractive and most preferred countries to carry out clinical trials, primarily due to diverse human gene pool and cost-competitiveness. However, unlike other healthcare products such as therapeutic drugs, there is a lack of regulations over usage of medical devices. Moreover, prior systematic empirical analysis that examine the medical device based clinical trials is also not well established. This study attempted to ascertain the determinants of participant recruitment, selection of locations and time taken to conduct medical device clinical trials. Medical devices that are clinically tested in India in the period of 2008 to 2014 were obtained from CTRI website. 108 out of 279 records were identified as medical device clinical trial registrations. Collected data was analyzed to know the device type, disease category, sponsors involved, participant enrolment, locations and the duration of the device trial. In this study, the category of sponsorship, device type and disease category were found to have significant influence with respect to the selection of number of participants, locations and the time taken to execute medical device clinical trials.


Clinical trials, Sponsorship, Participant recruitment, Locations, Duration, India

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