Current Science

Open Access Open Access  Restricted Access Subscription Access

Conducting clinical trials only in India’s large cities is unlikely to sample the country’s ethnicity sufficiently well


Affiliations
1 Indian Statistical Institute, Economics and Planning Unit, Qutub Institutional Area, New Delhi 110 017, India, India
2 Observer Research Foundation, 20, Rouse Avenue Institutional Area, New Delhi 110 002, India, India
3 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India, India
 

Around the world, there have been calls to include parti­cipants of diverse ethnicities in every clinical trial. In India, some years ago, a Parliamentary Committee was informed that trials are run in cosmopolitan cities of the country, and that this ensured suitable ethnic representation. The Indian Council of Medical Research, New Delhi, has defined six zones of the country from where sampling needs to be done to ensure good ethnic coverage. We found that no city has adequate representation from all the zones. However, possibly, a suitable sampling strategy in some cities could replace running trials from a few zones

Keywords

Clinical trials, cosmopolitan cities, diversity, ethnicity, sampling strategy.
User
Notifications
Font Size

  • Liu, K. A. and Mager, N. A. D., Women’s involvement in clinical trials: historical perspective and future implications. Pharm. Pract. (Granada), 2016, 14, 708.

  • Caldwell, P. H., Murphy, S. B., Butow, P. N. and Craig, J. C., Clin-ical trials in children. Lancet, 2004, 364, 803–811.

  • Amorrortu, R. P. et al., Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach. Trials, 2018, 19.

  • Aronson, L., A new NIH rule won’t be enough to make clinical re-search more inclusive. STAT, 2019; https://www.statnews.com/ 2019/01/31/nih-rule-make-clinical-research-inclusive/

  • Kahl, K. L., Despite showing interest, vulnerable populations lack sufficient clinical trial information. Cure Today, 2018; https:// www.curetoday.com/view/despite-showing-interest-vulnerable-pop-ulations-lack-sufficient-clinical-trial-information

  • Ashford, J., Clinical trials need to include more Black and other minority participants. Here’s how. STAT, 2020; https://www.statnews.com/2020/07/22/clinical-trials-include-more-black-and-other-minority-participants/.

  • Caplan, A. and Friesen, P., Health disparities and clinical trial re-cruitment: is there a duty to tweet? PLoS Biol., 2017, 15, e2002040.

  • Bulik, B. S., Pfizer TV ad aims for clinical trial diversity, with a special invite to the Black community. FiercePharma, 2021; https:// www.fiercepharma.com/marketing/pfizer-tv-ad-addresses-health-inequities-clinical-trials-highlighting-new-hub-for-drug

  • May, M., Twenty-five ways clinical trials have changed in the last 25 years. Nature Med., 2019, 25, 2–5.

  • Government of India, Department-related Parliamentary Standing Committee on Health and Family Welfare, Fifty-ninth report on the functioning of the Central Drugs Standard Control Organization (CDSCO). Rajya Sabha Secretariat, New Delhi, 2012.

  • Report of the Prof. Ranjit Roy Chaudhury Expert Committee to formulate policy and guidelines for approval of new drugs clinical trials and banning of drugs, July 2013.

  • Kumar, A., To conduct large scale clinical trials, ICMR calls for entries in Indian Clinical Trial & Education Network, 2021; https://www.timesnownews.com/mirror-now/in-focus/article/to-con-duct-large-scale-clinical-trials-icmr-calls-for-entries-in-indian-clinical-trial-education-network/816533

  • Majumder, P. P. and Basu, A., A genomic view of the peopling and population structure of India. Cold Spring Harb. Perspect. Biol., 2015, 7, a008540.

  • Ramamoorthy, A., Pacanowski, M. A., Bull, J. and Zhang, L., Racial/ethnic differences in drug disposition and response: review of re-cently approved drugs. Clin. Pharmacol. Ther., 2015, 97, 263–273.

  • Bumpus, N. N., For better drugs, diversify clinical trials. Science, 2021, 371, 570–571.

  • Indians abroad. Indian-origin doctors warn of racial bias in medical research in UK. NDTV.com, 2020; https://www.ndtv.com/indians-abroad/indian-origin-doctors-warn-of-racial-bias-in-medical-resea-rch-in-uk-2265389.

  • Knepper, T. C. and McLeod, H. L., When will clinical trials finally reflect diversity? Nature, 2018, 557, 157–159.

  • Anon., Frost & Sullivan, Asia: preferred destination for clinical tri-als, 2020; https://novotech-cro.com/sites/default/files2020-03/Frost_Sullivan_Asian_Clinical_Trials_Report_March_2020.pdf

  • Sze, S. et al., Ethnicity and clinical outcomes in COVID-19: a sys-tematic review and meta-analysis. Clin. Med., 2020, 29.

  • Institute of Medicine (US) Forum on Drug Discovery, Develop-ment and Translation, Transforming Clinical Research in the Unit-ed States: Challenges and Opportunities: Workshop Summary, Washington DC, National Academy Press, USA, 2010.

  • ICMR, National ethical guidelines for biomedical and health res-earch involving human participants, Indian Council of Medical Research, New Delhi, 2017


Abstract Views: 167

PDF Views: 73




  • Conducting clinical trials only in India’s large cities is unlikely to sample the country’s ethnicity sufficiently well

Abstract Views: 167  |  PDF Views: 73

Authors

Mudit Kapoor
Indian Statistical Institute, Economics and Planning Unit, Qutub Institutional Area, New Delhi 110 017, India, India
Shamika Ravi
Observer Research Foundation, 20, Rouse Avenue Institutional Area, New Delhi 110 002, India, India
Gayatri Saberwal
Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India, India

Abstract


Around the world, there have been calls to include parti­cipants of diverse ethnicities in every clinical trial. In India, some years ago, a Parliamentary Committee was informed that trials are run in cosmopolitan cities of the country, and that this ensured suitable ethnic representation. The Indian Council of Medical Research, New Delhi, has defined six zones of the country from where sampling needs to be done to ensure good ethnic coverage. We found that no city has adequate representation from all the zones. However, possibly, a suitable sampling strategy in some cities could replace running trials from a few zones

Keywords


Clinical trials, cosmopolitan cities, diversity, ethnicity, sampling strategy.

References





DOI: https://doi.org/10.18520/cs%2Fv123%2Fi12%2F1514-1517