The Association of Clinical Research Organizations (ACRO) recently released a report asserting “Clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world.” ACRO represents “companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices”.
If the ethical issues are properly addressed, ACRO sees many benefits to encouraging globalized clinical trials. These include: the increased speed of drug development, improving local economies, and finding new markets for products. To avoid incidents like the 1996 Trovan debacle, ACRO recommends increasing the FDA’s resources, encouraging local government measures to protect research subjects while facilitating globalization, and ensuring equity in ethics:
“All participants in clinical research — no matter where they live or the environment in which research takes place — be protected by the same level of safety and ethical considerations, and that they be afforded the same standard of care, including adherence to the GCP principles promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)”.
Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels, Report Says. Association of Clinical Research Organizations (ACRO), PRNewswire-USNewswire. July 21, 2009.
“Enormous” improvement in emerging-country trials, claims ACRO. Peter Mansell, PharmaTimes. July 22, 2009.
The International Conference on Harmonisation – http://www.ich.org/
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009 Feb 19;360(8):816-23. PMID: 19228627.
ACRO Comments on NEJM Article on Globalization of Clinical Research. Association of Clinical Research Organizations, Reuters. February 20, 2009.
NHLBI Stops Study of Treatment for Pulmonary Hypertension in Patients with Sickle Cell Disease Due to Safety Concerns. National Heart, Lung, and Blood Institute (NHLBI), NIH News. July 28, 2009.
Are clinical trials risky or dangerous? ABC Action News. July 27, 2009.
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Manimal Planet: Anti-Mermaid Legislation Rises from the Deep. Jonathan D. Moreno, Science Progress. July 24, 2009.
Financial Conflicts of Interest 101: How Money Shapes Research and How Policy Can Protect Patients. Vivian Cheng, Science Progress. July 20, 2009.
Context counts when assessing the social value of research. Nancy Walton, The Research Ethics Blog. July 19, 2009.
Data Bank: Public Support for Stem Cell Research On the Rise. Vivian Cheng, Science Progress. July 16, 2009.
Obama’s Guidelines on Human Stem Cell Research: Expanding Funding, Improving Oversight. Robert Streiffer, Bioethics Forum. July 16, 2009.
Merck and Schering-Plough settle investigation. Marley Seaman (AP), The Washington Post. July 15, 2009.
Obama and the President’s Council on Bioethics: An Insider’s View. Ryan M. Antiel, Bioethics Forum. July 13, 2009.
Public Praises Science; Scientists Fault Public, Media. The Pew Research Center for the People & the Press, Survey Reports. July 9, 2009.
Jesus Goes to Bethesda: Just how religious is Obama’s nominee for director of the NIH? Chris Wilson, Slate. July 9, 2009.
‘Synthetic sperm’ from stem cells raises hope for male infertility. Mark Henderson, The Times. July 8, 2009.
Related: Transforming Stem Cells into Sperm Cells Yields Unexpected Bioethical Questions. Andrew Plemmons Pratt, Science Progress. July 13, 2009.