Post an Unforeseen Outcome of Serial Volunteering in Clinical Trials, What Does the Affected Community Want?

Abstract

Background and Aims: A disturbing trend is largely seen in clinical trials that recruit healthy volunteers,

where vulnerable low-income groups are over-volunteering, leading to adverse health outcomes. There is a

need for an awareness study of the affected rural community that has witnessed an unforeseen outcome of

clinical trial participation.

Method: Data on knowledge, attitude, practice and educational materials about clinical trial participation

using a semi-structured interview schedule was collected from 192 heads of households from Nagampet

Village in Telengana state, South India, that had been making headlines in the news because of the death

of one of its residents due to adverse effects of repeated participation in clinical trials. Descriptive and

Multivariate analysis of variance was used.

Results: 99% of heads of household were married men with 69.8% belonging to Lower Middle Class and

34.9% less than a primary education. Majority (86.5%) were not aware about clinical trial process. 68.8%

opined that family members should reject the individual’s voluntary decision about taking part in clinical

trials because they fear the death of the only earning member of the family due to any ill-effects from clinical

trial participation.

Conclusion: This study brings out what the people want in order to avert another death or another unforeseen

event in their village due to clinical trial participation. They want a professional such as teacher, doctor or

nurse to explain to them the crucial steps in clinical trial participation during gram sabha and special village

gatherings. Well-informed decision-making in clinical trial participation through reliable sources would

encourage them to take medical help when in need and not to be lured by middle-men or agents.