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Review
. 2013 Jan;2(1):44-9.
doi: 10.4103/2278-330X.105896.

Challenges in launching multinational oncology clinical trials in India

Kamal S Saini  1 , Gaurav Agarwal  2 , Ramesh Jagannathan  3 , Otto Metzger-Filho  4 , Monika L Saini  5 , Khurshid Mistry  6 , Raghib Ali  7 , Sudeep Gupta  8
Affiliations
Review

Challenges in launching multinational oncology clinical trials in India

Kamal S Saini et al. South Asian J Cancer. 2013 Jan.

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.

Keywords: Cancer; India; South Asia; challenges; clinical trials; delays; obstacles; oncology; regulatory; research.

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Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Indicative clinical trial application review process in India, which takes approximately 4 to 8 months in total. (CT: Clinical Trial, CDSCO: Central Drugs Standard Control Organization, NDAC: New Drug Advisory Committee, Q&;A: Question and Answer) (Source: adapted from www.cdsco.nic.in)
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References

    1. Maiti R, Raghavendra M. Clinical trials in India. Pharmacol Res. 2007;56:1–10. - PubMed
    1. Schwartsmann G, Ratain MJ, Cragg GM, Wong JE, Saijo N, Parkinson DR, et al. Anticancer drug discovery and development throughout the world. J Clin Oncol. 2002;20(Suppl 18):47S–59. - PubMed
    1. Mano MS, Rosa DD, Dal Lago L. Multinational clinical trials in oncology and post-trial benefits for host countries: Where do we stand? Eur J Cancer. 2006;42:2675–7. - PubMed
    1. Eudaric A. Managing clinical logistics for clinical trials in emerging markets. [Last accessed on 2012 Jul 15]. Available from: www.parexel.com/index.php/download_file/view/69 .
    1. Gupta S, Nag S, Dawood S. Challenges and opportunities in the design and implementation of breast cancer clinical trials in developing countries. Clin Investig. 2012;2:579–87.