Surgical Clinical Trials in India: Underutilized Opportunities

Abstract

Clinical trials in Surgery are central to research; however, very few surgical clinical trials are conducted in India. Such paucity of surgical trials is a cause for concern, and prompted us to explore the recent landscape of surgical trials in India. We reviewed all clinical trials from general surgery or subspecialties of general surgery registered with the Clinical Trials Registry of India website between 2018 to 15 th May 2021. Specific details such as the surgical subspecialty, study design, multicentric or single institution and funding were obtained. We found a total of 16,710 trials, out of these 4119 (24.6%) were related to all surgical fields. Only 136 (0.8%) trials were found from general surgery and its subspecialties. Most trials were registered from Central Government Institutions (48%), followed by State Government Medical Colleges (11%). Most number of trials was registered from GI surgery (32%). Most (90.5%) trials were single centre based. Common barriers to research are well known; if the State Government Medical Colleges can mentor a culture of research from an early stage of surgical training it can improve research productivity. Multicentre trials, involving smaller hospitals from tier 2 and tier 3 cities, are a potential solution to one of the major obstacles of surgical trials i.e. small number of patients; especially in this pandemic induced draught of elective surgical operations. A positive change in attitude of surgeons and provision of necessary funding can encourage more surgical clinical trials in India.