Clinical Trials Trickling Away Drug Discovery & Development

Clinical Trials Trickling Away Drug Discovery & Development
By Ted Agres -Deputy Managing Editor, Washington Times

The number of clinical trials in the United States and the number of board-certified principal investigators (PIs) conducting them has declined dramatically in recent years.

These shifts reflect cancellations of drugs entering phase III trials as well as the outsourcing of clinical trials to other countries, mainly in “Latin America”, Eastern Europe, India, and Asia.

This migration, which is driven largely by cost savings and recruitment efficiencies, is expected to accelerate over the next few years. In so doing, it will further erode the US clinical research enterprise and have as-yet unforeseen implications for drug discovery and development. The trend lines for clinical trials have been sloping downward for several years: PIs increasingly are pulling out of clinical trials work, and the proportion of female to male PIs has been steadily declining since 1992, even as the number of female physicians has been increasing. In 2003, only 12% of PIs were women, even though they accounted for 28% of all board-certified physicians. "The capacity of the market to conduct clinical trials for industry sponsors is eroding, and efforts to establish a well-trained pool of clinical investigators may become more difficult," says Kenneth Getz, research fellow at Boston Tufts University's Center for the Study of Drug Development. Getz analyzed a US Food and Drug Administration (FDA) database of more than 100,000 PIs who registered to conduct clinical trials of investigational drugs between 1977 and 2004. His results, published in the May/June 2005 issue of the CSDD's "Impact Report," found that the number of US-based clinical trials dropped by 10.6% from 2001 to 2003, while the total number of PIs declined by 11.4%. At the same time, the number of active PIs outside the United States grew by 8%, suggesting a migration to locales where studies are cheaper and recruitment easier. This emphasis on efficiencies is also seen in the United States, where drug company sponsors have been shifting clinical trials from cities in the Northeast and Midwest to the South, where expenses are less and physicians are more eager to participate in industry sponsored clinical trials.

Most disturbing, 45% of all PIs conducting clinical trials in the United States in 2000 decided to quit after their studies ended, compared to a 27% turnover rate during the early 1990s. In addition to fewer drugs entering phase III trials, part of the problem is compensation. From 1998 to 2003, research sponsors held the size of study grants flat at a median of $60,000 even as the number of procedures in each study protocol rose dramatically, the BostonTufts CSDD reported. While the picture for US clinical trials may seem dismal, the outlook is bright elsewhere, as drug manufacturers embrace the shift to overseas trials. GlaxoSmithKline says 29% of its clinical trials are currently being conducted outside the United States and Western Europe.

The company expects that number to grow to 50% in two years. Last year, 50% of Wyeth Pharmaceuticals' trials were conducted outside the United States and Western Europe, and next year the company expects it to reach 70%. "As the clinical research services industry matures, it continues to struggle to provide more efficient study conduct in the clinical research process," states BioWorld's "Clinical Trials State of the Industry Report 2005: Market Forces Drive Change in Drug Development" published in May. Worldwide, the clinical trials industry grew 12.3% to $18.5 billion from 2003 to 2004, fueled largely by global contract research organizations (CROs) and the expansion into “Latin America”, Central and Eastern Europe (CEE), India and Asia, the report states.