Trial by Hire

By Elliott, Carl | Mother Jones, September/October 2010 | Go to article overview
Save to active project

Trial by Hire


Elliott, Carl, Mother Jones


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.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
Loading One moment ...
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited article

Trial by Hire
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

While we understand printed pages are helpful to our users, this limitation is necessary to help protect our publishers' copyrighted material and prevent its unlawful distribution. We are sorry for any inconvenience.
Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.

Are you sure you want to delete this highlight?