Adding Ancillaries: Clinical trials

January 6, 2006

This is the fifth in a series of articles on specific ancillary services that can boost your bottom line and keep you and your practice busy in a competitive healthcare market.

Every year, thousands of physicians sign up to conduct clinical trials, lured by intellectual challenge as well as extra income. Yet within two years about 50 percent drop out. "They didn't know what they were getting into," says neurologist Louis Kirby, medical director of Pivotal Research Centers in Sun City, AZ. "You have to love research, and it takes a level of organization most doctors aren't used to."

Nevertheless, the work can be mentally stimulating and professionally gratifying, says San Francisco internist Jacob Lalezari, who has investigated a number of antivirals. (He authored an article in The New England Journal of Medicine about a new HIV-1 fusion inhibitor, and was recently interviewed on network TV about a new vaccine against certain types of the human papillomavirus.)

Participating in a clinical trial allows you to bring innovative treatments and state-of-the-art therapeutic practices to your patients. And because subjects aren't charged for treatment-they might even receive a small stipend for participating-you may be able to treat patients who otherwise couldn't afford care.

Many novice researchers work as subinvestigators or with trial-management organizations until they've established enough credibility to turn their practices into independent trial sites. Other ways to get started:

Contact site-management and trial-management organizations that offer centralized services and may provide training for clinical research. For a list of these, go to the CenterWatch website ( http://www.centerwatch.org) and click on Industry Provider Profiles.

Look at http://www.clinicaltrials.gov, and visit the websites of pharmaceutical companies.

You can also read industry publications, such as R&D Directions and CenterWatch's monthly newsletter, or ask drug reps who visit your office to put you in touch with the right people at their company. Finally, you can network at industry meetings, especially those of the Association of Clinical Research Professionals (703-254-8100; http://www.acrpnet.org) and the Drug Information Association (215-442-6100; http://www.diahome.org).

Equipment

Study drugs must be securely stored, so be sure to have a lockable cabinet, preferably equipped with an alarm. "Only the study coordinator and other authorized personnel should have a key to this cabinet," says Kirby.

You'll also need a patients' scale, blood-drawing station, sphygmomanometer, ECG machine, emergency kit, desktop centrifuge, lockable refrigerator, and a minus-20-degree freezer.

Space

FP David Ginsberg recommends designating one room as your study coordinator's office and furnishing it with a desk, computer, telephone, and Internet connection, as well as easy access to a fax machine, a copier, office supplies, and exam rooms. The longer the study, the more on-site filing and storage space the study office will need. In addition, the site monitor who the study sponsor sends to your practice periodically will need a desk and enough working space to set up a computer-preferably in or near the study coordinator's office. Patients who participate in the study can be seen in a regular exam room, but you'll have a lower dropout rate if you have a comfortable reception area and ample parking for them.

Staff/training