Lack Of Human Test Subjects Has Drug Makers Scrambling

      Biotech and pharmaceutical companies are looking for more than a few good patients. And they're turning to consultants, jumping on the Internet bandwagon and stringing advertising banners behind small planes to find them.

      As the companies know only too well, the struggle to recruit patients for the clinical trials needed to get a drug to market is becoming ever more competitive and costly.

      One Maryland biotechnology company has spent more than a year trying to recruit patients to test its new therapy for bladder cancer, but has signed up only 20 of the 150 patients required.

      Several other companies, all testing a similar drug, wound up in a heated battle for the same patients. Another spent nearly $1 million on a national advertising campaign and attracted just a couple dozen patients.

      Those are just a few of the war stories.

      More than 80 percent of biotech and pharmaceutical companies miss their deadlines for enrolling patients, in some cases by more than a year. And every day that a trial is delayed means an estimated $1.3 million in direct and lost opportunity costs, according to CenterWatch Inc., a Boston publishing company that focuses on clinical trials.

      The stakes are getting higher as the pace of scientific research accelerates. Since 1993, the number of drugs in company pipelines has doubled. Innovations in technology and the unraveling of the human genome are expected to herald an unprecedented age of discovery, meaning more drugs, more trials, more competition for patients, and more money to lose.

      Patients in clinical trials get free medical care and reimbursement for their time and expenses. But they are not paid to participate. That would surely boost recruitment rates, researchers say, but paying people to undergo potentially risky therapies would violate federal rules and ethical standards.

      So the search for patients is becoming a key issue.

      ``Companies are doing the math and figuring out how much these delays can cost,'' said Patricia Jones, a managing director at Feinstein Kean Healthcare, a Cambridge, Mass., consulting firm that helps biotech companies recruit patients.

      ``Both pharmaceutical and biotech companies have a lot at stake,'' she said. ``Biotech may feel the pain a little more. Wall Street isn't kind when a biotech company misses a milestone it promised to make.''

      Most biotech companies don't have products or revenue, so they depend on money from investors - who judge their worth on the promise and progress of what's in their pipelines.

      Delays in clinical trials not only increase the cost of bringing a drug to market; they decrease a drug's potential earnings as the clock runs down on its patent.

      As a result, biotech and pharmaceutical companies are beginning to take advantage of organizations like Feinstein Kean Healthcare and BBK Patient Recruitment in Newton, Mass., to meet their enrollment goals.

      And other firms and Internet companies like Veritas Medicine in Cambridge are being formed to address the burgeoning need.

      In the eight years since BBK Patient Recruitment began, its president, Bonnie Brescia, has seen a whole new industry emerge to support clinical trials and patient recruitment. Companies are turning to radio, television and newspaper ads in greater numbers than ever. They are reaching out to patients on the Internet. And they are realizing the importance of planning well in advance.

      ``It used to be that companies only came to us after the fact, when they were in trouble and desperate for help,'' Brescia said. ``Then they began coming to us at the moment they were starting the trial. Now, they come a few months in advance.''

      Not planning ahead is a mistake a company makes only once, Jones said.

      The Maryland company Intracel Corp., for instance, sought out Feinstein Kean's help after running into trouble recruiting patients for its bladder cancer trials.

      Dr. Bill Gannon joined Intracel as vice president of clinical and medical affairs after the recruiting began early last year. He now expects it to last until June 2002, a year longer than originally anticipated.

      The company is competing for patients against at least six other bladder cancer trials. And there is a long list of criteria for patients, Gannon said, making it extremely difficult to find participants.

      To avoid a repeat of the experience, Gannon decided to get help for the company's upcoming trial for a colon cancer vaccine. While he was at it, he also asked for help to speed up recruitment in the bladder cancer trial.

      ``There are more clinical trials going on today than at any other point in time that we've known of,'' Gannon said. ``Pharmaceutical companies and biotech have resources to invest in research, and they have products in the pipeline. With that comes the need for expanded patient populations that we don't seem to get.''

      Medicines Co., a Cambridge biotech, spent a year planning a clinical trial for which it needed 17,000 heart attack patients to test its drug Angiomax. The company is on schedule, enrolling about 200 patients a week in a particularly competitive area of study, cardiology. Dr. Clive Meanwell, the company's chief executive, credits research, planning and creativity.

      The company decided to recruit in the United States and abroad to expand its patient pool, he said. It translated forms, literature and pamphlets into several languages, kept physicians informed with conference calls and e-mails, and set up a 24-hour hot line to answer questions. It signed up academic organizations to help organize networks of regional hospitals.

      And for another, smaller trial of the same drug, Medicines Co. designed a paperless system, allowing patients and physicians to fill out forms, diaries and questionnaires and to see information about the trial online.

      ``You've got to take this seriously,'' Meanwell said. ``But you've got to be creative. Anything you can do to make it more interesting, to give people more feedback, is very important.''

      Ken Getz, the president of CenterWatch, said only 10 percent of the 60 million people who could participate in studies ever contact a trial site. The key to solving the recruitment dilemma, he said, is reaching the other 90 perc

c.2000 The Boston Globe