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Challenges in launching multinational oncology clinical trials in India.

ABSTRACT: In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is of advantage to Indian healthcare system in general, and cancer patients in particular. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country. In this article, the authors investigate the reasons for this discrepancy, highlight critical bottlenecks, and propose ways to ameliorate the situation.

SUBMITTER: Saini KS

PROVIDER: S-EPMC3876625 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Challenges in launching multinational oncology clinical trials in India.

Saini Kamal S KS Agarwal Gaurav G Jagannathan Ramesh R Metzger-Filho Otto O Saini Monika L ML Mistry Khurshid K Ali Raghib R Gupta Sudeep S

South Asian journal of cancer 20130101 1

In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is of advantage to Indian healthcare system in general, and cancer patients in particular. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country. In this article, the authors investigate the reasons for this discrepancy, highlight critical bottl ...[more]

PMID: 24455545

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Project description:BackgroundNovel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute - Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study.Main bodyWe discuss three ethical requirements for clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunity to be enrolled and benefit from the trial, but due to insufficient accrual, the trial may generate clinically insignificant findings. Inadequate sample size in study arms and the use of surrogate endpoints may result in a drug approval without confirmed efficacy. Moreover, complexity, limited quality and availability of tumor samples may not only introduce bias and result in unreliable and unrepresentative findings, but also can potentially harm patients and assign them to an inappropriate therapy arm. Secondly, we refer to benefits and risks. Novel clinical trials can gain important knowledge on the variety of tumors, which can be used in future trials to develop effective therapies. However, they offer limited direct benefits to patients. All potential participants must wait about 2 weeks for the results of the genetic screening, which may be stressful and produce anxiety. The enrollment of patients whose tumors harbor multiple mutations in treatments matching a single mutation may be controversial. As to informed consent - the third requirement we discuss, the excessive use of phrases like "personalized medicine", "tailored therapy" or "precision oncology" might be misleading and cause personal convictions that the study protocol is designed to fulfill the individual health-related needs of participants.ConclusionsWe suggest that further approaches should be implemented to enhance scientific validity, reduce misunderstandings and risks, thus maximizing the benefits to society and to trial participants.

Dataset Information

Challenges in launching multinational oncology clinical trials in India.

Publications

Challenges in launching multinational oncology clinical trials in India.

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