Trial by Hire

Article excerpt

What happens when profit margins drive clinical research?

A DECADE AGO, when the inspector general of the Department of Health and Human Services (hhs) investigated the recruitment practices of pharmaceutical trials, researchers complained that research sponsors were demanding unrealistically tight deadlines to enroll subjects. Asked by the ig what sponsors were looking for in trial sites, one researcher replied, "Number one-rapid enrollment. Number two-rapid enrollment. Number three-rapid enrollment." Many researchers attributed the unrelenting pressure to the fact that trials were being managed by businesspeople, not clinicians.

Over the past 20 years, medical research has become a largely privatized, and thoroughly Taylorized, business. Two-thirds of clinical trials are now privately run. Many trials are advertised by patient recruitment specialists, carried out by "contract researchers," approved by for-profit ethics boards, and written up for publication by commercial medical education agencies. The largest of the new private industries are contract research organizations (cros), which range from small niche agencies to multinational corporations that manage all aspects of clinical trials, from ethics approval and subject recruitment to the submission of clinical data to the fda. Quintiles, the company that managed the study in which Dan Markingson was enrolled, is the largest, with 14 percent of the $11.4 billion global market.

cros save money for pharmaceutical companies by deploying the principles of industrial management: breaking trials down into narrow, discrete steps, which can be carried out with maximum efficiency by specialized workers who can be paid relatively low wages. According to Vanderbilt University social scientist Jill Fisher, author of Medical Research for Hire, very little experience is required to be a cro "monitor" - a middle manager, often a nurse, who coordinates the various sites involved ina study. Monitors usually make less than their counterparts at universities or pharmaceutical companies, and job turnover is very rapid. Fisher says, "The goal of many monitors is to be hired by the pharmaceutical industry."

In contrast, the private physicians paid to supervise clinical trials are often very wellcompensated. A part-time contract researcher conducting four or five clinical trials a year can expect to earn an average of $300,000 in extra income. Yet they generally have little if any research training. They do not generate original scientific ideas, design studies, or analyze the results. Their main role is to help recruit subjects and oversee their trial participation.

Research subjects are the most highly prized commodities in the clinical trials industry. Four out of five clinical trials are delayed because of difficulties recruiting subjects. These delays can be costly, as the patent clock on new drugs starts ticking as soon as the patent is filed.

As cros have discovered, many research subjects can be persuaded to enroll because they have no health insurance or because they are too poor to afford medication. (According to Fisher, a common cro term for these patients is "ready-to-recruit.") In the cafe study, for instance, a Quintiles study monitor suggested that each of the cafe study site coordinators try recruiting subjects at homeless shelters. Nevertheless, early on the University of Minnesota trial site was apparently struggling to keep subjects in the study. …