Factors Influencing Participation Of Healthy Volunteers In Clinical Trials: Findings From A Cross-Sectional Study In Delhi, North India

• Main Authors: Ranjan R, Agarwal NB, Kapur P, Marwah A, Parveen R
• Format: Article
• Language: English
• Published: Dove Medical Press 2019-11-01
• Series: Patient Preference and Adherence
• Subjects: clinical trial; healthy volunteers; financial incentive; india
• Online Access: https://www.dovepress.com/factors-influencing-participation-of-healthy-volunteers-in-clinical-tr-peer-reviewed-article-PPA

Rajesh Ranjan,1,2 Nidhi Bharal Agarwal,1 Prem Kapur,3 Amit Marwah,1 Rizwana Parveen1 1Centre for Translational and Clinical Research, School of Chemical and Life Sciences, New Delhi 110062, India; 2Department of Pharmaceutical Medicine, School of Pharmaceutical Education And Research, New Delhi 110062, India; 3Department of Medicine, Hamdard Institute of Medical Sciences and Research, New Delhi 110062, IndiaCorrespondence: Nidhi Bharal AgarwalCentre for Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi 110062, IndiaTel [phone]Fax [phone]Email [e-mail]: To identify the specific motivations that drive healthy volunteers to consent for their participation in clinical studies. Additionally, the study aimed to document the socio-demographic determinants of participation in the trial related solely to the intention of securing financial gains.Patients and methods: This cross-sectional study was conducted among subjects who participated as healthy volunteers in clinical trials conducted by Contract Research Organizations (CROs) of Delhi. Pre-tested, validated semi-structured questionnaires were used to collect baseline socio-demographic data, information about factors motivating participation in clinical trials, and pattern of utilisation of money received against participation in the trial. Logistic regression analysis was done to determine the factors that influenced participation in the trial related purely to the motive of securing financial gains.Results: A total of 400 participants were selected. The majority of the volunteers (77.5%) reported that their sole reason for participating in clinical trials was for monetary gain. Around a tenth of the volunteers participated with the intent to advance scientific knowledge and another 4.5% participated due to benefits of free medical check-ups. Participants in the age group of 29–38 years, those that were married, those residing in an urban slum, male participants, those with a high number of dependent family members (ie, 5 to 8), and those earning less than 5000 INR (71 USD) a month had higher odds of participating in a clinical trial purely for the financial benefits. Those educated till intermediate and above had lower odds of participation in the trial due to monetary benefits.Conclusion: Our study shows that healthy volunteers in Delhi consider participation in clinical trials mainly because of the prospect of financial reward. More research is needed to inform judgments around the ethics of providing financial rewards and enrollment of healthy research volunteers.Keywords: clinical trial, healthy volunteers, financial incentive, India