medigraphic.com
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

2019, Número 5

Siguiente >>

Rev Invest Clin 2019; 71 (5)


III. The Role of the Research Ethics Committees in the Regulation of Pharma-Sponsored Studies

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

Idioma: Ingles.
Referencias bibliográficas: 28
Paginas: 297-305
Archivo PDF: 750.81 Kb.


RESUMEN

Sin resumen.


REFERENCIAS (EN ESTE ARTÍCULO)

  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.




2020     |     www.medigraphic.com