Regulating International Clinical Research: an Ethical Framework for Policy-makers

Overview

Journal BMJ Glob Health

Specialty Public Health

Date 2020 May 29

PMID 32461225

Citations 6

Authors

Bernardo Aguilera

David DeGrazia

Annette Rid

Affiliations

Soon will be listed here.

Abstract

The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries. However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct their research elsewhere, potentially depriving the local population of the opportunity to benefit from international clinical research. In this paper, we propose a three-step ethical framework that helps policy-makers to navigate this trade-off. We use a recent set of regulatory protections in Chile to illustrate the practical value of our proposed framework, providing original ethical analysis and previously unpublished data from Chile obtained through freedom of information requests.

Citing Articles

Methodological insights from the EPISTOP trial to designing clinical trials in rare diseases-A secondary analysis of a randomized clinical trial.

Wied S, Hilgers R, Heussen N, Kotulska K, Dirani M, Kuchenbuch M PLoS One. 2024; 19(12):e0312936.

PMID: 39625912 PMC: 11614242. DOI: 10.1371/journal.pone.0312936.

The critical need to accelerate cerebral palsy research with consumer engagement, global networks, and adaptive designs.

Thomas S, Novak I, Ritterband-Rosenbaum A, Lind K, Webb A, Gross P J Pediatr Rehabil Med. 2024; 17(1):9-17.

PMID: 38552123 PMC: 10977364. DOI: 10.3233/PRM-240014.

Global Equity in Clinical Trials: An ASCO Policy Statement.

Al Sukhun S, Vanderpuye V, Taylor C, Ibraheem A, Wiernik Rodriguez A, Asirwa F JCO Glob Oncol. 2024; 10:e2400015.

PMID: 38484198 PMC: 10954071. DOI: 10.1200/GO.24.00015.

Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries.

Modlin C, Sugarman J, Chongwe G, Kass N, Nazziwa W, Tegli J Wellcome Open Res. 2023; 8:120.

PMID: 38089903 PMC: 10714106. DOI: 10.12688/wellcomeopenres.18915.2.

Data flow within global clinical trials: a scoping review.

Kwok K, Sati N, Dron L, Murthy S BMJ Glob Health. 2022; 7(4).

PMID: 35410953 PMC: 9003606. DOI: 10.1136/bmjgh-2021-008128.

References

Wolitz R, Emanuel E, Shah S . Rethinking the responsiveness requirement for international research. Lancet. 2009; 374(9692):847-9. DOI: 10.1016/S0140-6736(09)60320-2. View

Wilson P, Giessler K, Morris M . Impact of a Clinical Trial in Two District Hospitals in Ghana: Perspectives of Ghanaian Researchers. J Empir Res Hum Res Ethics. 2018; 13(5):486-493. DOI: 10.1177/1556264618804965. View

MacMahon S, Perkovic V, Patel A . Industry-sponsored clinical trials in emerging markets: time to review the terms of engagement. JAMA. 2013; 310(9):907-8. DOI: 10.1001/jama.2013.276913. View

Zwierzyna M, Davies M, Hingorani A, Hunter J . Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005. BMJ. 2018; 361:k2130. PMC: 5989153. DOI: 10.1136/bmj.k2130. View

Marathe P, Tripathi R, Shetty Y, Kuyare S, Kamat S, Thatte U . Payment for participation in clinical research: Review of proposals submitted to the ethics committees. Perspect Clin Res. 2018; 9(2):64-69. PMC: 5950612. DOI: 10.4103/picr.PICR_159_16. View

Hoekman J, Frenken K, de Zeeuw D, Heerspink H . The geographical distribution of leadership in globalized clinical trials. PLoS One. 2012; 7(10):e45984. PMC: 3468615. DOI: 10.1371/journal.pone.0045984. View

Vist G, Bryant D, Somerville L, Birminghem T, Oxman A . Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev. 2008; (3):MR000009. PMC: 8276557. DOI: 10.1002/14651858.MR000009.pub4. View

Shukla S . India's amended trials regulations spark research exodus. Lancet. 2013; 382(9895):845. DOI: 10.1016/s0140-6736(13)61833-4. View

Grady C . The challenge of assuring continued post-trial access to beneficial treatment. Yale J Health Policy Law Ethics. 2005; 5(1):425-35. View

10.

Franzen S, Chandler C, Lang T . Health research capacity development in low and middle income countries: reality or rhetoric? A systematic meta-narrative review of the qualitative literature. BMJ Open. 2017; 7(1):e012332. PMC: 5278257. DOI: 10.1136/bmjopen-2016-012332. View

11.

Hay M, Thomas D, Craighead J, Economides C, Rosenthal J . Clinical development success rates for investigational drugs. Nat Biotechnol. 2014; 32(1):40-51. DOI: 10.1038/nbt.2786. View

12.

. Ethics. Fair benefits for research in developing countries. Science. 2002; 298(5601):2133-4. DOI: 10.1126/science.1076899. View

13.

Shen L, Chou H, Huang C, Chou G, Chan W, Wu F . Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan. Contemp Clin Trials. 2011; 32(4):485-91. DOI: 10.1016/j.cct.2011.04.003. View

14.

Berlin J, Glasser S, Ellenberg S . Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health. 2008; 98(8):1366-71. PMC: 2446471. DOI: 10.2105/AJPH.2007.124537. View

15.

Porter G . Regulating clinical trials in India: The economics of ethics. Dev World Bioeth. 2017; 18(4):365-374. DOI: 10.1111/dewb.12156. View

16.

Saenz C, Heitman E, Luna F, Litewka S, Goodman K, Macklin R . Twelve years of Fogarty-funded bioethics training in Latin America and the Caribbean: achievements and challenges. J Empir Res Hum Res Ethics. 2014; 9(2):80-91. PMC: 5523831. DOI: 10.1525/jer.2014.9.2.80. View

17.

Sugarman J, Bhan A, Bollinger R, Gupta A . India's new policy to protect research participants. BMJ. 2013; 347:f4841. DOI: 10.1136/bmj.f4841. View

18.

Drain P, Robine M, Holmes K, Bassett I . Trial watch: global migration of clinical trials. Nat Rev Drug Discov. 2014; 13(3):166-7. PMC: 4006355. DOI: 10.1038/nrd4260. View

19.

Atal I, Trinquart L, Porcher R, Ravaud P . Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials. PLoS One. 2015; 10(12):e0145122. PMC: 4681996. DOI: 10.1371/journal.pone.0145122. View

20.

Khoury M, Figueroa F . Magic realism: a Latin American paradigm for stem cell research & development?. Gene Ther. 2019; 27(1-2):2-5. DOI: 10.1038/s41434-019-0079-2. View