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

Area of Science:

• Clinical Trials
• Participant Perspectives
• Health Research Ethics

Background:

• Research based on primary data from 2012-13 on clinical trial (CT) participant experiences.
• Focuses on understanding the multifaceted aspects of CTs from the participant viewpoint.

Purpose of the Study:

• To describe participant perspectives on recruitment, informed consent, adverse events, and compensation in clinical trials.
• To explore factors influencing recruitment, information asymmetry, power dynamics, and sociocultural influences.
• To understand the gap between regulations and realities in the Indian CT sector.

Main Methods:

• In-depth interviews with 36 clinical trial participants across four Indian states.
• Interviews with key informants including investigators, CRO representatives, sponsors, and Ethics Committee members.

Main Results:

• Identified key factors influencing participant recruitment and engagement in clinical trials.
• Explored challenges related to informed consent, adverse event reporting, and compensation.
• Highlighted the disparity between regulatory frameworks and practical implementation in the Indian CT landscape.

Conclusions:

• Participant perspectives are vital for the ethical conduct of clinical trials.
• Upholding participant rights and ensuring their voices are heard is paramount.
• Recent legal amendments aim to improve CT conduct and participant protection.