Clinical trials registered in clinical trial registry of India: A survey
Manonmani Alvin Jose1★★ Corresponding author
Volume 2, Issue 4 · pp. 289–290 · PUBLISHED 2011 · DOI: 10.4103/0976-500X.85952
ABSTRACT
As this is just the initiation of accumulating data related to clinical trials taking place in India, exploration of this data may give some insight of the situation and some suggestions for improvement like in a survey of clinical trial registries of western countries it was observed that few ethical aspects like assent from minors and post-trial obligations were not reported adequately.[4] Post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been conducted. The strong need for this was felt to avoid exploitation of participants and to increase trust development in researcher participant relationship. It has been realized that “informed consent” has only limited direct application in pediatrics. Only patients who have appropriate decisional capacity and legal empowerment can give their informed consent to medical care. In all other situations, parents or other surrogates provide informed permission for diagnosis and treatment of children with the assent of child whenever appropriate. Hence, this study was planned with the objective of exploration of clinical trial registry of India for reporting of various parameters such as methodological, ethical considerations, and disease burden to get insight of the present situation.
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Jose, M. A. (2011). Clinical trials registered in clinical trial registry of India: A survey. Journal of Pharmacology and Pharmacotherapeutics, 2(4), 289–290. https://doi.org/10.4103/0976-500X.85952