An analysis of certain fields of interventional drug trials registered with Clinical Trials Registry – India

Abstract

Background There has been a significant increase in the number of trials registered with Clinical Trials Registry – India (CTRI) recently. We therefore wished to understand the current landscape of interventional, drug trials that have run in India. Methods We downloaded all trial records on 4 April 2018, and queried the data after it was formatted into an SQLite database. We distinguished trials hosted by India (India-only trials) and those co-hosted by India and other countries (India-etc trials). Results We analyzed eight fields of data, with the following key results: (a) Year of registration: The India-etc set suffered a serious dip in 2013. Both sets increased sharply in 2017. (b) Phase: Phase 3 trials were the most common in both sets of data, but were manifold more common in the India-etc set. 30% of the India-only trials had no phase information. (c) Trial sites: Four states each account for 50% or more of the sites in both sets of data. Also, 7–8 cities accounted for 50% or more sites in both sets. (d) Ethics committees: Over 70% of India-only trials had a single ethics committee, but the India-etc trials had a much greater spread. For each set, the maximum exceeded 60 committees per trial. (e) Principal Investigator (PI): 84% and 73% of PIs in the India-only and India-etc sets, respectively, had run a single trial each. One PI had run as many as 44 trials. (f) Primary sponsors: global pharma companies sponsored less than 5% of the India-only set but 92% of the India-etc set. (g) Fraction of subjects from India in India-etc trials: An abnormally large fraction of participants are not recruited from India. (h) Countries co-hosting the India-etc trials: The pattern was similar to that found for international trials co-hosted by Australia. Conclusions It is important to understand the landscape of trials being run in any country, to understand the recent past, in case of any red flags, and to serve as inputs to changes in policy. The data also serves as a baseline for the future, to ascertain the impacts of new policies, locally or globally.