Medknow Publications and Staff Society of Seth GS Medical College and KEM Hospital, Mumbai, India
Publication date
01/01/2008
Field of study
India is considered as a preferred site for conducting global clinical
trials. Existence of a large treatment-naοve population,
availability of English-speaking, skilled doctors, plenty of clinical
material, and cost-savings are obvious advantages for carrying out
clinical research in India. However, challenges exist at various
levels. Lack of formal training in bioethics and research methodology,
heavy burden of clinical duties and sub-optimal administrative support
restrict investigators. Absence of oversight of functioning of ethics
committees (ECs) and lack of mechanisms for ensuring quality of ethics
review heighten societal concerns about safety of participants.
Conducting research on issues not relevant to local needs and failure
to ensure post-trial access further enhance society′s cynicism.
These issues need to be tackled through capacity building, training of
investigators and EC members, strengthening of EC functioning and
encouraging greater community participation