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Perspectives in Clinical Research

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July-September 2021 | Vol 12 | Issue  3 Table ofContents RSS Feed
Addressing challenges faced by trial sites and investigators
Sandeep B Bavdekar
Clinical research, including clinical trials, done appropriately, helps advance science and improves treatments. It is also important that during such research, the safety, well-being, and confidentia...
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Review Article
National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials
Kiruthika Sivagourounadin, Mirunalini Ravichandran, Priyadharsini Rajendran
The “National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials” prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as ...
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Review Article
Conducting community-based pediatric research in rural India: Experience from vadu rural health program
Aditi Apte, Girish Dayma, Himangi Lubree, Anand Kawade, Sanjay Juvekar, Ashish Bavdekar
This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced...
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Original Article
Compliance of Mumbai-based clinical trial sites with the Quality Council of India guidelines and evaluation of the challenges faced by the investigators
Brinal Figer, Nithya Jaideep Gogtay, Urmila Mukund Thatte
Purpose: A committee chaired by Dr. Ranjit Roy Chaudhary suggested accreditation of investigators, sites and ethics committees to improve the quality of trial conduct in the country. Prior to a...
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