Cancer Trials Ecosystem in India-Ready for Prime Time?

Executing global clinical trials for cancer is a long, expensive, and complex undertaking. While selecting countries global studies, sponsors must consider several aspects including patient pool, quality of trained investigators, competing trials, availability of infrastructure, and financial invest...

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Bibliographic Details
Published in:	JCO global oncology Vol. 10; no. 10; p. e2300405
Main Authors:	Mankan, Arun K, Shankar, Abhishek, Limaye, Sewanti, Ajaikumar, B S, Nachane, Prajakta, Singh, Navneet, Dawkhar, Shekhar, Batra, Ullas, Bhosekar, Amol, Ganguly, Sandip, Gawli, Pramod, Debnath, Khokan, Padalalu, Vivek, Reddy, Prasanth, Sundaramoorthy, Shanthi, Naveen, K K, Bondarde, Shailesh, Kumar, Praveen, Davis, Sanish, Ramkissoon, Shakti H, Chacko, Raju Titus, Vidal, Laura, Chico, Isagani, Hegedus, Andrew, Gupta, Sudeep, Saini, Kamal S
Format:	Journal Article
Language:	English
Published:	United States American Society of Clinical Oncology 01-06-2024
Subjects:	Clinical Trials as Topic Humans India Medical Oncology - standards Neoplasms - therapy India
Online Access:	Get full text
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Summary:	Executing global clinical trials for cancer is a long, expensive, and complex undertaking. While selecting countries global studies, sponsors must consider several aspects including patient pool, quality of trained investigators, competing trials, availability of infrastructure, and financial investment versus returns. With a large, often treatment-naïve, and diverse patient pool, relatively low cost, good quality health care facilities in urban areas, and a robust and well-trained workforce, India offers several advantages for conducting oncology clinical trials. However, there remains challenges, including a shifting regulatory environment in recent decades. With the implementation of the New Drugs and Clinical Trial Rules in 2019, India's regulatory atmosphere seems to have stabilized. In this article, we present a review of the evolving clinical trial landscape in India, highlight the current regulatory scenario, and discuss the advantages and challenges of selecting India as a potential location for conducting global oncology clinical trials.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1
ISSN:	2687-8941
DOI:	10.1200/GO.23.00405