Aguilar-Salinas CA, Pascual-Ramos V, Sierra-Madero JG; Loria-Acereto A, Zambrano-González E, Kaufer-Horwitz M, González-Duarte A

Language: English
References: 28
Page: 297-305
PDF size: 750.81 Kb.

ABSTRACT

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.

REFERENCES

1. Rosenblatt M. Clinical trials series-large pharma. N Engl J Med. 2017;376:e28.

2. Van Campen LE, Therasse DG, Klopfenstein M, Levine RJ. Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research. Curr Med Res Opin. 2015;31:2071-80.

3. Taljaard M, Weijer C, Grimshaw JM, et al. Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol. Trials. 2018;19:525.

4. Skierka AS, Michels KB. Ethical principles and placebo-controlled trials-interpretation and implementation of the declaration of Helsinki’s placebo paragraph in medical research. BMC Med Ethics. 2018;19:24.

5. Asai A, Kadooka Y. Reexamination of the ethics of placebo use in clinical practice. Bioethics. 2013;27:186-93.

6. Villasenor IR, Cabrera C. La bioetica y el uso de placebo en ensayos clinicos controlados. Rev Med IMSS. 2003;41:65-73.

7. Declaration of Helsinki; 2000. Available from: http://www.wma. net/e/home/htlm.

8. Rid A, Saxena A, Baqui AH, et al. Placebo use in vaccine trials: recommendations of a WHO expert panel. Vaccine. 2014;32:4708-12.

9. World Health Organization. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. Available from: http://www.apps.who.int/prequal/info_general/documents/ GCP/gcp1.pdf. [Accessed in October 27, 2018].

10. Simpson B, Khatri R, Ravindran D, Udalagama T. Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers. Soc Sci Med. 2015;131:247-54.

11. Holbein ME, Berglund JP. Understanding food and drug administration regulatory requirements for an investigational device exemption for sponsor-investigators. J Investig Med. 2012;60:987-94.

12. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167-70.

13. Grady C, Cummings SR, Rowbotham MC, et al. Informed consent. N Engl J Med. 2017;376:856-67.

14. Nijhawan LP, Janodia MD, Muddukrishna BS, et al. Informed consent: issues and challenges. J Adv Pharm Technol Res. 2013; 4:134-40.

15. Rothwell E, Wong B, Rose NC, et al. A randomized controlled trial of an electronic informed consent process. J Empir Res Hum Res Ethics. 2014;9:1-7.

16. Committee for Protection of Human Subjects. University of California, Berkeley. CPHS Guidelines. Compensation of Research Subjects. Available from: https://www.cphs.berkeley. edu/compensation.pdf. [Accessed in October 27, 2018].

17. Bosnjak Pasic M, Vidrih B, Sarac H, et al. Clinical trials in developing countries-ethical considerations. Psychiatr Danub. 2018; 30:285-91.

18. International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guidelines 8 and 15. Geneva: Council for International Organizations of Medical Sciences (CIOMS); 1993.

19. Ford N, Calmy A, von Schoen-Angerer T. Treating HIV in the developing world: getting ahead of the drug development curve. Drug Discov Today. 2007;12:1-3.

20. Mc Lean GR. Education and debate. A case for goodwill. BMJ. 1997;314:890.

21. Kubo S, Yamaoka K, Amano K, et al. Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study. Rheumatology (Oxford). 2017;56:1293-301.

22. Ethical and Policy Issues in International Research: clinical Trials in Developing Countries. Executive summary of Volume I: report and Recommendations of the National Bioethics Advisory Commission; 2001. Available from: https://www.bioethicsarchive.georgetown. edu/nbac/pubs.html. [Accessed in October 27, 2018].

23. International Conference on Harmonization. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice. Available from: https://www.ich.org/fileadmin/Public.../E6_R1_ Guideline.pdf. [Accessed in October 27, 2018].

24. Calis KA, Archdeacon P, Bain R, et al. Recommendations for data monitoring committees from the clinical trials transformation initiative. Clin Trials. 2017;14:342-8.

25. Food Drug Administration. Establishment and Operation of Clinical Trial Data Monitoring Committees. Available from: https://www.fda.gov/downloads/Training/.../UCM378800.pdf. [Accessed in October 27, 2018].

26. Hakoum MB, Jouni N, Abou-Jaoude EA, et al. Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance. BMJ Open. 2017;7:e015997.

27. Brokowski C, Adli M. CRISPR ethics: moral considerations for applications of a powerful tool. J Mol Biol. 2018;2018:S0022- 2836(18)30586-2.

28. Wendler D, Emanuel EJ, Lie RK. The standard of care debate: can research in developing countries be both ethical and responsive to those countries’ health needs? Am J Public Health. 2004;94:923-8.