“The invisible”: Participant’s experiences in clinical trials

Sarojini Nadimpally, Divya Bhagianadh | PICR | 2017

The paper discusses the perspectives of clinical trial participants about the various aspects of Clinical Trials (CTs) and is based on the primary research conducted by Sama in 2012-13. The paper describes the perspectives of participants on the relevant aspects of recruitment into CTs, reasons for participation in CTs, informed consent, adverse events and compensation. The role played by the push and pull factors in recruitment, the information asymmetry, the power imbalance between the health-care provider and seeker, the role of sociocultural factors, etc., are explored in the paper. Combined with the insights from other stakeholders, the study gives an understanding about the chasm between regulations and realities in the Indian CT sector. Further, the paper briefly explores the recent changes and amendments in the laws governing the CT sector that is aimed at improving the conduct of CTs and uphold the rights of participants.

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