`Trials’ and tribulations

By Thomas Ginsberg

Inquirer Staff Writer

(excerpted and edited)

            PHILADELPHIA - The $10 billion-a-year clinical drug trial business kindly asks you to forget part of its name - the trial part.

            The industry, which held its annual meeting in Philadelphia , is trying to raise U.S. participation in drug studies and combat what some call negative news coverage of pharmaceutical development and marketing, notably legal troubles. Surveys suggest “trial” just isn't helping.

            "People view `trial’ as litigious," said Christine K. Pierre, a patient recruitment consultant and speaker at the weeklong convention of the Drug Information Association, a global industry clearinghouse based in Horsham , PA. "Stop calling it a `trial, and your enrollment will increase."

            Deft wordsmithing was just one tactic mulled by the estimated 8,000 attendees from hundreds of companies worldwide that do everything from recruit patients to crunch data to process results of the trials - uh, drug research studies.

            Drug trials are crucial, involving testing of pharmaceutical products in humans before they can be prescribed widely. Hundreds, sometimes thousands, of subjects are needed for a single study to generate statistically valid results that such agencies as the U.S. Food and Drug Administration require from companies seeking a license to market a drug for a particular condition. In the U.S. in the last decade, subjects have been harder to come by. The exact reason is up for debate, but it has coincided with safety and financial scandals involving physicians or hospitals doing trials for profit.

            "We must try to regain the public trust," Joan A. Kroll-Chambers, a director at Tufts University's Center for the Study of Drug Development, told one panel. The falloff in patients has led to fewer U.S. clinical trial sites. Today, about 33% of U.S. sites provide almost 75% of all trial data, while another 33% fail to sign up any subjects, said David Ulrey, president of Midwest Clinical Support Inc., an Illinois-based contract firm.

            At the same time, drug companies have started conducting more trials in India, China, Eastern Europe and other regions, where the expenditure goes further and trials get done faster because of easier recruitment, Pierre and others said.

            In part, many in the drug trial business appear to blame the media for coverage of trial problems, such as the death of 18-year-old Jesse Gelsinger in a University of Pennsylvania trial in 1999. At one session, almost all attendees raised their hands when asked how many considered media coverage of their industry "negative." Then the speaker, Pierre, showed results of surveys indicating media coverage actually had little impact on patients' attitudes about joining trials.

            "When a drug is pulled from the market, the public seems to consider it proof the system works," Pierre said.

            The real solution, she and others said, may lie in persuading more physicians to take part in studies, emphasizing the safeguards for patients and professionalism of investigators, highlighting the benefits to society, and making the trial more cost-effective for the sponsor.

            Oh, avoid the draconian-sounding word “trial” can help. Said Ellis: "When we deal with the industry or physicians or investigators, `trial’ is fine; when we talk to patients, we try to use different words."