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Year : 2017  |  Volume : 8  |  Issue : 1  |  Page : 5-10

”The invisible”: Participant's experiences in clinical trials

Sama Resource Group for Women and Health, New Delhi, India

Correspondence Address:
Sarojini Nadimpally
B-45, 2nd Floor, Main Road Shivalik, Malviya Nagar, New Delhi - 110 017
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.198550

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Background: The paper discussing the perspectives of clinical trial participants about the various aspects of CTs is based on the primary research conducted by Sama in 2012-13. Methodology: In-depth interviews were conducted with 36 CT participants from the states of New Delhi, Gujarat, Maharashtra and Andhra Pradesh. In addition to CT participants, other key informants including investigators, representatives of Contract Research Organizations (CROs), sponsor, Ethics Committee (EC) members etc. were also interviewed to develop a comprehensive understanding of the functioning of the CT sector. Findings and Discussion: 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. Conclusion: Participants are the most important stakeholders in a CT setting. It is imperative that their voices are heard and their rights upheld for the ethical conduct of CTs.

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