Friday, August 22, 2008

Inside Life Sciences

FDA regs mean tighter management of foreign trials

Weary of the red tape and high costs of clinical trials in the United States, life sciences companies are increasingly outsourcing clinical trials for new drugs and devices to developing nations. The number of companies outsourcing clinical trials has exploded with trials frequently conducted in China, Eastern Europe, India and South America. Recognizing this trend, the U.S. Food and Drug Administration has announced new regulations for its acceptance of foreign clinical trial data. Facing a tightening regulatory landscape, life sciences companies must examine the benefits and pitfalls of conducting clinical trials abroad.

Since the FDA’s initial acceptance of foreign clinical trial data in the mid-1980s, life sciences companies have increasingly conducted clinical trials abroad. The FDA has only recently required companies to register clinical trials, but according to estimates, nearly half of all trials are now conducted abroad. Unlike domestic clinical trials, foreign trials often bypass costly and time-consuming FDA regulations.

In the four years since the recall of blockbuster painkiller Vioxx by Merck & Co. Inc., the FDA has tightened its regulatory belt, focusing on safety and side effects. With the FDA demanding more extensive clinical trial data and the cost of developing a new drug skyrocketing into the hundreds of millions of dollars, cost-savings are paramount.

Conducting a clinical trial outside the U.S. can save more than 60 percent in costs and significantly cut the time involved. Emerging countries offer a bevy of skilled and low-cost workers, as well as large and diverse populations of eager participants.

Clinical trials require hundreds, even thousands of patients. Recruiting patients, in particular minorities and adolescents, can be daunting in the U.S., where doctors have little incentive to refer patients, insurers are unwilling to cover many trials, and patients fear becoming human guinea pigs. Conversely, patients in other countries are far more receptive to offers to participate in paid trials, and centralized health care systems make it easier to recruit patients.

Foreign trials offer deep discounts without sacrificing data validity or ethical standards. According to Ashleigh Palmer, CEO of Critical Biologics Corp. in Cambridge, clinical trials in Hong Kong have cost-effectively advanced their critical care theranostic platform without compromising data quality or patient safety.

 Moreover, foreign nations are increasingly adopting international ethical standards to protect patient rights. Thus, foreign trials are accurate and ethical, but faster and less expensive, allowing life sciences companies to comply with FDA regulations without breaking the bank. 

Cultural, religious, and ethical obstacles are frequently encountered when outsourcing clinical trials. Foreign nations may have different conceptions of health and varying degrees of acceptance of Western medicine. 

Life sciences companies must be vigilant in obtaining informed consent, particularly when treating poor and illiterate patients. Additionally, a common ailment in the U.S. may be uncommon elsewhere, limiting the pool of trial participants. From a nationalistic perspective, conducting trials abroad delays Americans’ access to these cutting edge treatments. Finally, companies risk FDA rejection of foreign trial data and may face further FDA requirements to conduct a trial on U.S. soil.

Effective October 27, the revised FDA regulations will require foreign clinical trials to be conducted in accordance with FDA good clinical practices to ensure the studies are credible, accurate and protect the rights, safety, and well being of patients.

Practically, the new FDA regulations amount to little more than additional paperwork, but the allure of foreign  trials will remain, and companies must  carefully to avoid potential pitfalls.

David J. Dykeman is a patent attorney and shareholder in the firm of Greenberg Traurig LLP in Boston. He can be reached at dykemand@gtlaw.com. Lauren E. Jones works at Greenberg Traurig LLP in Boston and attends Cornell University Law School.