Clinical Drug Trials

Author:

Nundy Samiran,Kakar Atul,Bhutta Zulfiqar A.

Abstract

AbstractThis is a procedure to evaluate the efficiency and safety of a drug or medical device by monitoring its effects on participants. The research is usually done when a molecule is thought to be useful for treating humans. Thus any trial requires a triad of:

Publisher

Springer Singapore

Reference7 articles.

1. FAQS for new drug regulation. Last accessed on 29th April 2020. Available on https://thsti.res.in/cdsa/FAQs+for+New+Drug+Regulation/.

2. Ethics in Clinical research. Ed Munjal YP, Prakash AP, Pangtey GS. Evangel, New Delhi 2019.

3. India’s New Drugs and Clinical Trials Rules: An Industry Perspective. Last accessed on 29th April 2020. Available on https://www.raps.org/news-and-articles/news-articles/2019/7/indias-new-drugs-and-clinical-trials-rules-an-in.

4. Real World Evidence – Post Marketing Observational Studies (PMOS). Last accessed on 29th April 2020. Available on https://www.mcdougallscientific.com/real-world-evidence-post-marketing-observational-studies/.

5. Mallath MK, Chawla T. Investigators’ viewpoint of clinical trials in India: Past, present and future. Perspect Clin Res. 2017;8:31–6.

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