The following is a response formulated by ACRP's Regulatory Affairs Committee to "Deadly Medicine," a Vanity Fair article by investigative reporters Donald L. Bartlett and James B. Steele.
On behalf of the more than 18,000 individuals who are members of the Association of Clinical Research Professionals and the Academy of Pharmaceutical Physicians and Investigators, and who represent more than 60 countries dedicated to clinical research and development, we would like to respond to the article by Bartlett and Steele published in the January 2011 issue of Vanity Fair.
Although it is true that clinical trials have become "global" in nature, the perception of the article is based on incomplete and misleading information. With the goal of making new treatments available more quickly and to people everywhere in the world, opening sites in more countries results in improved enrollment rates and ensures that market applications reflect the global conduct of the trial and a product's eventual global distribution after approval.
Each and every one of our members assure that clinical research, anywhere in the world, is conducted according to the “good clinical practice” (GCP) guidelines and standard operating procedures that are the gold standards under which clinical research is performed and human subject volunteers are protected.
All global trials are subject to review and approval by independent ethics committees at the local and often global level. In addition, each trial must be submitted to each country's regulatory agency, which actively oversees the conduct of clinical trials in its country or region. These health authorities/regulatory agencies work collaboratively with their counterparts in the U.S. and Europe, among others. Our members around the world regularly participate in audits of their clinical research activities by local authorities, the U.S. Food and Drug Administration, and the European Medicines Agency.
It is unfortunate that an obviously biased article written from this perspective casts our members, who are dedicated, ethical clinical research professionals, in such a negative light.