Challenges in launching multinational oncology clinical trials in India

Kamal S. Saini; Gaurav Agarwal; Ramesh Jagannathan; Otto Metzger-Filho; Monika L Saini; Khurshid Mistry; Raghib Ali; Sudeep Gupta

doi:10.4103/2278-330X.105896

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Review Article

02 (

); 044-049

doi:

10.4103/2278-330X.105896

Challenges in launching multinational oncology clinical trials in India

Kamal S. Saini^1,, Gaurav Agarwal², Ramesh Jagannathan³, Otto Metzger-Filho⁴, Monika L Saini⁵, Khurshid Mistry⁶, Raghib Ali⁷, Sudeep Gupta⁸

1 Breast International Group, Department of Medical Oncology, Jules Bordet Institute, Université libre de Bruxelles, Brussels

2 Department of Endocrine and Breast Surgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh

3 Clinical Research, AstraZeneca Pharma India Ltd., Bangalore, Karnataka

4 Breast Oncology Center, Dana-Farber Cancer Institute, Boston

5 Department of Anatomie Pathologique, Cliniques Saint Luc, Université catholique de Louvain, Brussels

6 Indian Cooperative Oncology Network, Mumbai, Maharashtra

7 INDOX Cancer Research Network, University of Oxford, Oxford

8 Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra

*Corresponding author: Dr. Kamal S. Saini. kamal.saini@bordet.be

Published: 2020-12-31

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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This article was originally published by Thieme Medical and Scientific Publishers Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

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

References

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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.
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Thatte UM, Bavdekar SB. Clinical research in India: Great expectations? J Postgrad Med 2008;54:318-23.
Bhatt A. Indian clinical trials: Paradigm shift from speed to quality? Perspect Clin Res 2012;3:1-3.
Julka P. Clinical trials in India-dilemmas for developing countries. Available from: http://www.ecronacunova.com/pdf/whitepapers/Whitepaper-CT%20in%20India.pdf. [Last accessed on 2012 Jul 15].
Bavdekar SB. Informed consent documents submitted for initial review: What do they state about compensation for injured research participants? Indian J Med Sci 2009;63:455-60.
Nundy S, Gulhati CM. A new colonialism?--Conducting clinical trials in India. N Engl J Med 2005;352:1633-6.
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Taur SR, Bavdekar SB, Thatte UM. Survey of ethics committee protocol approval letters: Compliance with Schedule Y/ICMR guidelines 2006. Indian J Med Ethics 2011;8:214-6.
Brahme R, Mehendale S. Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India. Indian J Med Ethics 2009;6:78-84.
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Yuji K, Narimatsu H, Tanimoto T, Komatsu T, Kami M. Sharing information on adverse events. Lancet 2011;377:1654.
Campion EW. Medical research and the news media. N Engl J Med 2004;351:2436-7.
Saini KS, Taylor C, Ramirez AJ, Palmieri C, Gunnarsson U, Schmoll HJ, et al. Role of the multidisciplinary team in breast cancer management: Results from a large international survey involving 39 countries. Ann Oncol 2012;23:853-9.
Thatte UM, Kulkarni-Munshi R, Kalekar SA. Review of policies for injuries to research participants in India. J Med Ethics 2009;35:133-9.
Kang G. Putting patients first: Draft guidelines for compensation for research-related injury in clinical trials in India. Indian J Med Ethics 2012;9:77-9.
Pramesh CS, Badwe RA. Will the proposed compensation guidelines for research-related injury spell the death knell for clinical research in India? J Postgrad Med 2012;58:156-8.
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Malhotra P. The impact of TRIPS on innovation and exports: A case study of the pharmaceutical industry in India. Indian J Med Ethics 2008;5:61-5.
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Raina V. Doing cancer trials in India: Opportunities and pitfalls. Ann Oncol 2005;16:1567-8.

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[1] Maiti R, Raghavendra M. Clinical trials in India. Pharmacol Res 2007;56:1-10.

[2] 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.

[3] 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.

[4] Eudaric A. Managing clinical logistics for clinical trials in emerging markets. Available from: www.parexel.com/index.php/download_file/view/69/. [Last accessed on 2012 Jul 15].

[5] 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.

[6] Jayakumar PB. Clinical trials losing the plot in India. Available from: http://www.business-standard.com/india/news/clinical-trials-losingplot-in-india/419660/. [Last accessed on 2012 Jul 15].

[7] Karlberg J. Development of sponsored clinical trials in Asia. Available from: http://www.ctmagnifier.org/2008/M2008_1_05.aspx. [Last accessed on 2012 Jul 15].

[8] Available from: http://clinicaltrials.gov/. [Last accessed on 2012 Jul 15].

[9] Available from: http://ctri.nic.in/Clinicaltrials/login.php. [Last accessed on 2012 Jul 15].

[10] Noronha VT, Jamshed A, Hai MA, Wattegama S, Baral RP. A fresh look at oncology facts on south central Asia and SAARC countries. South Asian J Cancer 2012;1:1-4.

[11] Thatte UM, Bavdekar SB. Clinical research in India: Great expectations? J Postgrad Med 2008;54:318-23.

[12] Bhatt A. Indian clinical trials: Paradigm shift from speed to quality? Perspect Clin Res 2012;3:1-3.

[13] Julka P. Clinical trials in India-dilemmas for developing countries. Available from: http://www.ecronacunova.com/pdf/whitepapers/Whitepaper-CT%20in%20India.pdf. [Last accessed on 2012 Jul 15].

[14] Bavdekar SB. Informed consent documents submitted for initial review: What do they state about compensation for injured research participants? Indian J Med Sci 2009;63:455-60.

[15] Nundy S, Gulhati CM. A new colonialism?--Conducting clinical trials in India. N Engl J Med 2005;352:1633-6.

[16] Kumra G. McKinsey and company Indian Pharma 2015: Unlocking the potential of the Indian pharmaceutical market. Available from: http://www.mckinsey.com/locations/india/mckinseyonindia/pdf/india_pharma_2015.pdf. [Last accessed on 2012 Jul 15].

[17] Global Pharma looks to India: Prospects for growth. Available from: http://www.pwc.com/en_GX/gx/pharma-life-sciences/pdf/global-pharma-looks-to-india-final.pdf. [Last accessed on 2012 Jul 15].

[18] Evolving R and D for emerging markets. Nat Rev Drug Discov 2010;9:417-20.

[19] Drabu S, Gupta A, Bhadauria A. Emerging trends in contract research industry in India. Contemp Clin Trials 2010;31:419-22.

[20] Available from: http://www.guardian.co.uk/news/datablog/2012/jun/30/healthcare-spending-world-country?intcmp=239. [Last accessed on 2012 Jul 15].

[21] Ghosh J, Gupta S, Desai S, Shet T, Radhakrishnan S, Suryavanshi P, et al. Estrogen, progesterone and HER2 receptor expression in breast tumors of patients, and their usage of HER2-targeted therapy, in a tertiary care centre in India. Indian J Cancer 2011;48:391-6.

[22] Singh S. Indian pharma enters the global arena. Cell 2007;128:811-4.

[23] Srinivasan S, Loff B. Medical research in India. Lancet 2006;367:1962-4.

[24] Available from: http://www.decisionview.com/sites/default/files/analyst_report_pdfs/decisionview_enrollment_optimization_report_mar2012.pdf. [Last accessed on 2012 Jul 15].

[25] Available from: http://164.100.47.5/newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf. [Last accessed on 2012 Jul 20].

[26] Available from: http://articles.economictimes.indiatimes.com/2012-07-10/news/32618689_1_new-drugs-drug-regulation-drug-controller-general. [Last accessed on 2012 Jul 20].

[27] Available from: http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/hit-by-red-tape-clinical-trial-companies-eye-south-east-asia-for-expansion/articleshow/14077184.cms. [Last accessed on 2012 Jul 20].

[28] Gupta YK, Padhy BM. India′s growing participation in global clinical trials. Trends Pharmacol Sci 2011;32:327-9.

[29] Available from: http://www.touchbriefings.com/pdf/17/pt031_r_4_bakhle%5B1%5D.pdf. [Last accessed on 2012 Jul 20].

[30] Kadam R, Karandikar S. Ethics committees in India: Facing the challenges! Perspect Clin Res 2012;3:50-6.

[31] Tharyan P. Ethics committees and clinical trials registration in India: Opportunities, obligations, challenges and solutions. Indian J Med Ethics 2007;4:168-9.

[32] Available from: http://www.who.int/bulletin/volumes/86/8/08-010808/en/index.html. [Last accessed on 2012 Jul 18].

[33] Tharyan P, George AT, Kirubakaran R, Barnabas JP. Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications. J Clin Epidemiol 2012;66:10-22.

[34] Pauranik A, Bharani A, Bhargava S, Bajpai A, Jain H, Verma P. Misleading report on clinical trials in India. Lancet 2012;379:1947-8.

[35] Taur SR, Bavdekar SB, Thatte UM. Survey of ethics committee protocol approval letters: Compliance with Schedule Y/ICMR guidelines 2006. Indian J Med Ethics 2011;8:214-6.

[36] Brahme R, Mehendale S. Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India. Indian J Med Ethics 2009;6:78-84.

[37] Available from: http://www.ijppsjournal.com/Vol2Suppl1/215R.pdf. [Last accessed on 2012 Aug 3].

[38] Jayaraman K. India mulling stricter laws to curb unethical trials. Nat Med 2012;18:182.

[39] Available from: http://m.indianexpress.com/news/10-die-per-week-in-drug-trials-in-india/971834/. [Last accessed on 2012 Aug 2].

[40] Available from: http://articles.timesofindia.indiatimes.com/2011-06-06/india/29624892_1_clinical-trials-drug-controller-general-dcgi. [Last accessed on 2012 Aug 2].

[41] Ramamurthy NV. Inept media trials of clinical trials. Perspect Clin Res 2012;3:47-9.

[42] Yuji K, Narimatsu H, Tanimoto T, Komatsu T, Kami M. Sharing information on adverse events. Lancet 2011;377:1654.

[43] Campion EW. Medical research and the news media. N Engl J Med 2004;351:2436-7.

[44] Saini KS, Taylor C, Ramirez AJ, Palmieri C, Gunnarsson U, Schmoll HJ, et al. Role of the multidisciplinary team in breast cancer management: Results from a large international survey involving 39 countries. Ann Oncol 2012;23:853-9.

[45] Thatte UM, Kulkarni-Munshi R, Kalekar SA. Review of policies for injuries to research participants in India. J Med Ethics 2009;35:133-9.

[46] Kang G. Putting patients first: Draft guidelines for compensation for research-related injury in clinical trials in India. Indian J Med Ethics 2012;9:77-9.

[47] Pramesh CS, Badwe RA. Will the proposed compensation guidelines for research-related injury spell the death knell for clinical research in India? J Postgrad Med 2012;58:156-8.

[48] Available from: http://zeenews.india.com/news/nation/bonanza-over-5-000-new-medical-seats-created_784825.html.[Last accessed on 2012 Aug 6].

[49] Arora RS, Arora P, Prabhu V, Eden T. Subsequent publication rate of studies from India presented at the annual congresses of SIOP. Pediatr Blood Cancer 2012;59:956-8.

[50] Malhotra P. The impact of TRIPS on innovation and exports: A case study of the pharmaceutical industry in India. Indian J Med Ethics 2008;5:61-5.

[51] Dandona L. Clinical trials in India: Balancing economic opportunity with the public health context. Natl Med J India 2006;19:57-9.

[52] Raina V. Doing cancer trials in India: Opportunities and pitfalls. Ann Oncol 2005;16:1567-8.

Challenges in launching multinational oncology clinical trials in India

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