Abstract:

The aim of this study is to identify ethical issues and challenges in clinical research in India. This study provides clear picture of special ethical issues in clinical research such as conflict of interest, post trial access to investigational product and use of placebo. We examined clinical research professional perceptions on those issues.

Individuals (N=385) working in field of clinical research in India have participated in the study. This study involves self administered survey research for collection of data and information from participants through their responses. The survey questionnaire was validated by colleagues and guides and experts in the field. The survey elicited responses based on general experience and opinions of clinical research professionals. Participants were given the option to complete the survey on the internet. Surveys completed via the internet were stored in Microsoft excel. For data analysis SPSS software have been used and descriptive analysis have been conducted.

A total of 389 surveys were received, of which 385 were considered complete and used for this analysis. The respondents were from India, currently working in clinical research field. Demographic information pertaining to respondents such as education, type of organization age, experience etc have been collected, whether they had ethics training ever, and if yes which type of training they had. The data shows that majority have responded that they are not favouring post trial access to investigational product or it is not ethical. Further to that, participants were asked to select reasons for their opinion on post trial access to investigational product. If participant believes that post trial access to investigational drug is ethical, they have selected applicable reasons for their opinion. Majority of respondents favour use of placebo in clinical trials in general. If participant is favouring the use of placebo, further they have provided their opinion on possible steps to be taken care of in placebo controlled trial. Participants has been asked to rate the factors which can promote or causes conflict of interests in clinical trials. As per data, financial gain is the most affecting factor causing conflict of interests. Comparing responses employer wise, CROs, ECs and Study sites are rating “recruitment target” more than sponsors. The data shows that industry influence, patent or other commercial benefits are not highly affecting.

KEY WORDS

Placebo, Conflict of interest, post trial access, ethics

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