Sponsorship and characteristics of medical device clinical trials registered in Indian Trial Registry

Abstract

The present day world has been experiencing rapid technological advancement on the one hand and an ever increasing number of diseases afflicting the human beings on the other. To deal with the later, medical devices are innovated and introduced in to the market (making use of the technological advancements), on a continuous basis across the world. However, introducing an innovated medical device to the market poses innumerable challenges and therefore, these have to be clinically trialed before its market launch to ensure safety and efficacy. India has emerged as one of the attractive and preferred countries by sponsors to execute clinical trials because of its various advantages. Sponsors play a crucial role for the successful conduction of clinical trials. Given the fact that Indian medical devices industry is growing at a faster pace, this paper attempts to understand and highlight the characteristics of medical devices that are registered in Indian trial registry. The present study has been carried out based on secondary data covering 108 medical device clinical trial registrations accessed from Clinical Trial Registry of India (CTRI) database pertaining to the period 2008–2014. These 108 medical device trials are analyzed based on the type of sponsorship.