Memo From The Editor

On trials

Marianne Dekker Mattera

Over the last decade, more and more physicians have gotten involved in clinical trials as a practice sideline. Some physicians have been able to add $250,000 or more to the bottom line in a year. A physician in private practice who serves as principal investigator for a study will net as much as $30,000 from the average clinical grant of $56,000.

Pharmaceutical companies like having private practice docs do research—there are usually fewer bureaucratic hassles than they run up against with academic researchers and the patients recruited for the studies tend to be more representative of the general population.

To be fair, doing research isn't a cakewalk. There's plenty of paperwork, patients need close follow-up, and you'll need to hire at least one extra employee—a clinical research coordinator, usually a nurse—so that you're not the one who's dealing with all the meticulous record keeping. But it's certainly worth considering, especially since the demand for clinical investigators is growing by leaps and bounds. From 1994 to 2000, for instance, the number of principal investigators and subinvestigators more than tripled, from 14,100 to 46,000. And by 2005, it's expected that 56,000 clinical investigators will be needed to match research needs.

Clinical trials need patients, too. I've heard ads recruiting subjects on the radio, or seen them in newspapers; and I'm sure your patients have, too. So, even if you don't want to participate in trials yourself, your patients might benefit a lot from guidance on the subject from you.

Where do you learn more about clinical research? There are a number of associations devoted to the topic. You can contact The Association of Clinical Research Professionals at www.acrpnet.org or The American Academy of Pharmaceutical Physicians at www.aapp.org. The American Academy of Family Physicians offers several research groups and networks. For more information, visit the AAFP at www.aafp.org or call (800) 274-2237.

Our own sister company CenterWatch also provides extensive information on clinical trials for both physicians and patients. Their Web site, www.centerwatch.com , lists more than 41,000 industry- and government-sponsored clinical trials. It also has a notification and matching service that helps patients find trials they qualify for. CenterWatch also publishes An Investigator's Guide to Clinical Research, by retired FP-researcher David Ginsberg. It's in its third edition and provides a good, basic how-to guide for would-be investigators. How to Grow Your Investigative Site by Dr. Barry Miskin and Ann Neuer is for experienced researchers who want to kick it up a notch.

Sending patients interested in finding clinical trials to the CenterWatch site will definitely help them in their quest. But you can do them an even bigger favor by recommending CenterWatch's Informed Consent.

Truly informed consent is the key to all human research. Without it, we get the kinds of experiments done in Nazi Germany on mental patients and prisoners or in the US Public Health Service's Tuskegee syphilis trials. Although such atrocities seem inconceivable today, patients do die when enrolled in clinical trials and subjects need to know that going in. Informed Consent details what clinical trials are all about, what a participant should be told—not only about risks, but also about financial interests the researchers may have in the outcome of the trial—how to find out what you need to know about a study and those who are conducting it before you enroll, and what to do if things go wrong.

Sadly, participants in a clinical trial gone awry can end up in a trial before the judicial system. Without informed researchers and informed patients, that's all too likely to happen with greater frequency.

 

Marianne Mattera. Memo from the Editor: On trials. Medical Economics 2002;13:8.