Additional file 5: of An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India

Expanded methods, used to generate the data in the following sections. Sections 7–16 provide details on (7) The 1331 categories of Type of Study in 12,673 trials, year-wise from 2007–2018; (8) Determining the truly foreign trials; (9) Determining the unambiguously Indian trials, and error rates over time; (10) Determining the unambiguously Multinational trials, and error rates over time; (11) Identifying the actual trials in the categories Foreign, Indian and Multinational: A summary. (12) 55 Interventional Indian cases with Phase listed as PMS, and error rates over time; (13) For the redefined Indian and Multinational sets (i) cases of confusion between PMS and Phase 4 trials; (ii) cases where Type of Trial is BA/BE but Phase is 1–4; and (iii) Sites of study: Incorrect listing of cities. Error rates over time for some of these; (14) Missing data in terms of (i) Name of the PI was missing; (ii) for the redefined Indian set, and the Multinational set, cases where Type of Study was not available, but Phase of Trial was Phase 1, 1/2, 2, 2/3, 3, 3/4 or 4; (iii) Name of Primary Sponsor was missing; and (iv) the state hosting a trial was not listed. Error rates over time for some of these; (15) Examples of types of variations in PIs’ names; and examples, or the entire listing, of problems with ethics committees; and (16) A brief on the 47 trials conducted at the Malpani Multispeciality Hospital, Jaipur, Rajasthan. (ZIP 596 kb)