January 8, 2007

U.S. drug companies will increasingly outsource their clinical trials in the coming years, with "many top pharmaceutical companies" expecting to do up to 65 percent of their clinical trials abroad, according to the "Outlook 2007" survey by the Tufts Center for the Study of Drug Development.

The proportion of "1572" forms that clinical investigators are required to submit to the FDA before beginning a study that were submitted from research sites located outside the U.S. rose from about 15 percent in 1997 to 35 percent in 2005. To control this trend, sponsors, regulatory agencies and human subject protection programs are likely to increase training and oversight of investigators based abroad to bring them into compliance with U.S. good clinical practice guidelines, the study said.

Demand for contract research organization services for clinical trials is expected to grow at an annual rate of 16 percent over the next five years. At the same time, clinical trial protocols are growing much more complex: the number of procedures per protocol went up at an annual rate of 6 percent over the past 10 years, the report said, and this is likely to continue.

Another important trend the report highlighted is the growing number of drug approvals granted to small and midsize pharma companies. The report also noted that the pharma industry is increasingly focusing on medicines for specialty care, as opposed to drugs for broader populations, with the support of the FDA. On the regulatory side, the FDA and the European Medicines Agency are taking steps to improve decisionmaking consistency to create a more level playing field for all developers, and supporting efforts to bolster R&D efficiency.