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
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.
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