Cancer Trials Ecosystem in India-Ready for Prime Time?
JCO Glob Oncol
; 10: e2300405, 2024 Jun.
Article
en En
| MEDLINE
| ID: mdl-38870438
ABSTRACT
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Neoplasias
Límite:
Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
JCO Glob Oncol
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Estados Unidos