Navigating investigator-initiated clinical trials: A call for guidelines & monitoring frameworks from an Indian context

Abstract

Investigator-initiated clinical trials - also known as non-regulatory or academic clinical trials, are conducted by investigators from academia or research organizations. They usually aim to address scientific questions with insufficient commercial implications and generate real-world applicable solutions, unlike trials sponsored by the pharmaceutical industry which are primarily focused on marketing approval of products that have a commercial value. For the trial results to be credible, adhering to robust methodology and the highest quality standards is paramount. Currently, investigator-initiated clinical trials in India are beyond the purview of the national regulatory authority. They are guided mainly by the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 published by Indian Council of Medical Research. They lack an accepted framework for review, conduct, monitoring, reporting of adverse events, and participant compensation. Considering this scenario, we discuss the challenges faced in an investigator initiated clinical trial and explore plausible solutions.

Keywords: Investigator-initiated clinical trial; academic trial; clinical trial monitoring; non-commercial clinical trials; risk-based monitoring.

Fig. 1.

Proposed timelines of reporting a Serious Adverse Event (SAE). PI, principal investigator; IEC, Institutional Ethics Committee; CRF, case record form.

Fig. 2.

Process of how risk-based monitoring of a CT could be undertaken in an investigator-initiated trial. IP, investigational product.