How to get started in clinical trials

Key Points

Participating in clinical trials can be rewarding, both intellectually and financially, for physicians who are looking to advance the cause of science and find benefits for patients who haven't responded to standard therapies.

Physicians are typically attracted to clinical research by intellectual curiosity, financial incentives, and the desire to provide state-of-the-art care. But success requires more than a can-do attitude and good clinical practices. To prosper, a clinical investigator needs a dedicated support staff and an understanding of the business issues surrounding trial work.

Perhaps that's why, despite the dollars being spent on clinical trials-Pharmaceutical Research and Manufacturers of America-member companies spent $44.5 billion on research and development in 2007, compared with $37 billion in 2004-few physicians choose to become involved.

It doesn't have to be that way, experts say. Medical Economics has tapped the knowledge of a number of veteran investigators, who offer a look at the various factors to be considered prior to becoming involved in clinical trials. As they've found, trials could be an opportunity to broaden the horizons of science and to reap long-term rewards.

GETTING STARTED

Investigators are generally compensated on a per-subject basis, but the amount varies dramatically from trial to trial, depending on what the protocol requires, whether subjects complete the study, and other factors.

In a 2004 Harris Poll, 13 percent of physician respondents said they were currently doing investigative work. About half said they had never conducted a clinical trial, and another third had worked as investigators in the past, but were no longer involved.

The high washout rate doesn't surprise Ronald Surowitz, DO, a family practitioner in Jupiter, Florida, and a veteran clinical investigator. "Clinical trials can be intellectually stimulating, advantageous to patients, and profitable for doctors, but they're no place for starry-eyed illusions," he says. "They take time, money, commitment, and infrastructure."

Surowitz knows firsthand how difficult it can be to break into clinical research. The first time he tried, the trial closed before he could recruit a single subject. The second time, the trial sponsor nearly passed him over for lack of experience. On his third attempt, he participated in a trial for a nasal spray.

Though trials eventually became profitable for Surowitz, they took significant time and effort. He dedicated 10 to 20 hours a week to his trial work, in addition to his normal 40-hour-a-week practice.

But the extra work has paid off. Surowitz's research business, Health Awareness Inc., accounts for about half of his annual revenue.

Before sinking a lot of time or money into setting up shop, Surowitz recommends that physicians interested in becoming clinical investigators attend a class in good clinical practices-the principles and processes clinical investigators are expected to follow to ensure patient safety, protection, and privacy, and that data collection is reliable and accurate. The Association of Clinical Research Professionals offers a two-day course that costs $1,835 for non-members. (For more information, go to http://www.acrpnet.org.)

For physicians interested in pursuing clinical trials, getting started is something of a balancing act. "Investigators face the question of 'Which comes first, the staff or the volume?'? It's similar to the question of the chicken or the egg, " says Paul Covington, MD, who recently retired as executive vice president of development and chief medical officer at PPD, a clinical research organization based in Wilmington, North Carolina. Clinical investigators don't want to invest too much up-front money, but they need enough staff to conduct the trial.