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

机译：影响健康志愿者参与临床试验的因素：来自印度德里德里横断面研究的调查结果

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Purpose: 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.
机译：目的：确定推动健康志愿者同意参与临床研究的具体动机。此外，该研究旨在记录参与审判的社会人口决定因素，仅针对确保财政收益的意图。患者及方法：在参加由德里合同研究组织（CROS）进行的临床试验中参加的受试者的科目之间进行了这种横截面研究。预先测试，验证的半结构化问卷用于收集基线社会人口统计数据，有关激励参与临床试验的因素的信息，以及收到审判的参与的金额的利用模式。完成了物流回归分析，以确定影响参与临时与保护财务收益的动机的审判的因素。结果：选择共有400名参与者。大多数志愿者（77.5％）报告称，他们参加临床试验的唯一原因是货币增益。左右十分之一志愿者参加了推进科学知识的意图，另外4.5％的人因免费医疗检查的益处而参加。年龄组的参与者29-38岁，那些已婚的人，居住在城市贫民窟，男性参与者，依赖家庭成员多数（即5至8）的人，那些赚取不到5000 INR的人（71美元）一个月纯粹对财务福利纯粹参与临床试验的几率。那些受过教育的人和上述人员因货币福利而导致参与审判的几率较低。结论：我们的研究表明，德里的健康志愿者考虑参加临床试验，主要是因为财务奖励的前景。需要更多的研究来为提供提供财务奖励和健康研究志愿者的伦理渠道的判断。

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