Jeroze J. Dalal

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A large number of psychiatry studies are conducted in India. Psychiatry studies are complex and present unique challenges in the Indian setting. Ethical issues pertaining to the risk of worsening of illness, use of placebo and validity of informed consents are commonly faced. Site selection can be difficult due to the relative paucity of ICH-GCP(More)
The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7(th) June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability,(More)
INTRODUCTION An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment. MATERIALS AND METHODS We collected retrospective data of human epidermal growth factor receptor (HER2) positive Indian(More)
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