Meanwhile, all involved entities are keeping an eye on the outsourcing of clinical trials. At a Reuter’s Health Summit held Nov. 8–11, 2010 in New York City, FDA Commissioner Margaret Hamburg said that caring for patients properly means that drug companies must do more than just enter a country, conduct a study, and leave. They need to recognize that patients have made a contribution, taken risks, and deserve to be respected and provided with broader aspects of care.
Sue Pondrom is a medical journalist based in San Diego.
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Further Reading
If you’d like to read more, these policies, reports, and organizations address ethical considerations in international clinical trials.
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- World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human participants, which was adopted in June 1964 and has been updated several times: www.wma.net/en/30publications/10policies/b3
- The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: www.ich.org
- March 2001 FDA guidance for industry: Acceptance of foreign clinical studies: www.fda.gov/Regulatory Information/Guidances/ucm124932.htm
- U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: http://bioethics.georgetown.edu/nbac/clinical/Vol1.pdf
- Clinical trials in developing countries: How to protect people against unethical practices: www.edctp.org/fileadmin/documents/ethics/Clinical_Trials_in_Devel oping_Countries_How_to_Protect_Peoples_Against_Unethical_Practices.pdf
- Association of Contract Research Organizations: www.acrohealth.org
- Tufts Center for the Study of Drug Development: http://csdd.tufts.edu/
- Wemos, an advocate for individuals’ health rights in developing countries: www.wemos.nl/Eng/default.htm
References
- Office of Inspector General, U.S. Department of Health and Human Services. Challenges to FDA’s ability to monitor and inspect foreign clinical trials (OEI-01-08-00510). June 2010. Available at oig.hhs.gov/oei/reports/oei-01-08-00510.pdf. Accessed October 10, 2011.
- Briefing document for the Arthritis Advisory Committee meeting, for Benlysta (belimumab). November 16, 2010. Adelphi, Md.
- Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816-823.
- International Conference on Harmonization. Available at www.ich.org. Accessed October 10, 2011.
- Garnier J. Rebuilding the R&D engine in Big Pharma. Harvard Business Review. May 2008.
- ACRO news release. Clinical research safety and ethical standards in developing world up to U.S. levels. July 21, 2009. Available at www.acrohealth.org/clinical-research-safety-and-ethical-standards-in-developing-world-up-to-u.s.-levels.html. Accessed October 10, 2011.
- Piddicord D. Global clinical trials: Setting the record straight. ACRO News Release, April 26, 2011. Available at www.acrohealth.org/global-clinical-trials-setting-the-record-straight.html. Accessed October 10, 2011.
- van Huijstee M, Schipper I. Putting contract research organizations on the radar. February 2011. Available at http://somo.nl/publications-en/Publication_3615/at_download/fullfile. Accessed October 10, 2011.
- Code of Federal Regulations Title 21, Part 312, Subpart B. Investigational New Drug Application (IND).
- Code of Federal Regulations Title 21, Part 312.120(C)(1).