Web Linking Drug Trials With Test Patients

Drug companies have pills aplenty in the pipeline, but they won’t make it to market until they’ve been tested on humans.

Finding the right patients for trials of new drugs is a costly headache, though, for pharmaceutical firms and for the federal government, which also sponsors experimental trials.

Meanwhile, for people who are seriously ill, the appropriate trial can mean a shot at a new treatment that might help.

This could be a job for . . . the Internet.

Several Web sites have been launched with the aim of making money by linking patients to clinical trials--tests of experimental drugs, devices and procedures to determine whether they are effective and safe.

The usual recruitment methods include referrals from doctors as well as print and broadcast advertising.

The Internet, which brims with health information, has long been used by patient groups, medical centers, government agencies and others to post and trade free information about clinical trials. Perhaps the best-known comprehensive Web listing of clinical trials is the 5-year-old CenterWatch (https://www.centerwatch.com). DrKoop.com (https://www.drkoop.com), the well-known health portal, also lists trials.

In February, the federal government created https://www.clinicaltrials.gov, its first all-inclusive listing of trials sponsored by the National Institutes of Health, as well as some privately backed trials. Some drug firms also have created recruitment sites.

So, with all of this free clinical trial information on the Web, how does the e-business crowd plan to cash in? The answer is that drug firms are willing to pay to get appropriate patients into trials because a lack of patients often slows down the progress of trials.

Only 10% or less of eligible adults actually participate in experimental drug trials, said Ken Getz, president and chief executive of Boston-based CenterWatch, which began in 1994 as a newsletter publisher for the clinical trials industry. About 60%, however, say they might be interested in doing so.

Many people who consider signing up for a trial either change their minds or aren’t the right fit for the study. Getz said only one in 20 patients who inquire about participating actually finishes a trial. Only one in four of those who arrive for an initial screening finish.

The lost time and money is serious, said CenterWatch, which estimates that each day of delay costs a pharmaceutical firm on average $1.3 million. This figure takes into account both the direct daily costs of running a trial and lost days of selling a typical drug at its peak value.

Recruitment “is the No. 1 reason why trials fail, and it’s the No. 1 area where increased efficiency is possible,” said Dr. Bert Spilker, senior vice president of scientific and regulatory affairs at Pharmaceutical Research and Manufacturers of America, which represents large drug firms.

Commercial firms are betting that they can save drug companies time and money by getting appropriate patients into trials faster through the Internet. There are several emerging business plans among the commercial, comprehensive Web sites. All are free to patients and provide plenty of general information about trials and diseases. Some of the sites are paid by drug companies for every patient who enters a trial. Veritas Medicine (https://www.veritasmedicine.com), which launched in early November, will get from $200 to $1,000 per patient, depending on the trial, once it starts listing drug-firm trials in January.

“Today, anyone running clinical trials is paying much, much more than that” to line up suitable patients, said Dr. Joe Avellone, chief executive of Veritas, based in Cambridge, Mass.

EmergingMed, based in New York, launched its Web site (https://www.emergingmed.com) Oct. 30. Its initial focus is cancer, and it is paid either a flat fee to recruit for a trial or block of trials, or a per patient fee, said Courtney Hudson, the founder and chief executive.

Acurian (https://www.acurian.com), of Horsham, Pa., which recently launched its site, works both sides of the equation: It recruits patients and investigators--the doctors who help run clinical trials.

HopeLink (https://www.hopelink.com), expected to launch soon, will license its communication and database tools to pharmaceutical firms and expects to be incorporated into other health-related Web sites.

Many of those involved with clinical trials agree that recruiting patients is difficult and costly and that the Internet will have a growing role. But some are wary of the freewheeling Web.

“My concern about doing this on the Internet is that the patients might sign on to a trial without good knowledge about what they’re getting into,” said Dr. Ernesto Canalis, director of research and chairman of the institutional review board at St. Francis Hospital and Medical Center in Hartford, Conn. Every institution that conducts biomedical research on humans has such a board, which reviews every aspect of each medical study conducted at the institution--including patient recruitment.

Those running recruiting sites counter that their screening questionnaires make it much easier for patients to find out whether they qualify for certain trials. They said Web sites that merely list trials are full of medical jargon that most lay readers can’t decipher. In addition, no matter what happens on the Internet, patients still need to talk to one of the clinicians who is conducting the trial. In the end, a patient must sign informed consent documents attesting that he or she understands the patient’s role in a given research study.

The new crop of commercial Web sites report that they comply with institutional review board guidelines. Dr. Scott H. Kurtzman, associate professor of surgery and chairman of the institutional review board at the University of Connecticut Health Center, said he is more concerned about shady Web sites peddling quackery disguised as legitimate trials.

Web site executives acknowledge that Internet access is largely the domain of affluent white people and that the Web won’t be a source of diverse patient groups until access becomes more widely available. Finally, there is the question of the information that these sites collect. Patients generally have to provide some personal data in order to be linked to a site. Site executives said detailed profiles allow the Web sites to match the right patient with the right trial and that the information will never be sold or disclosed without the patient’s consent.

CenterWatch’s Getz said commercial sites may be sincere in swearing to never misuse the data, but that they might be tempted if they desperately need revenue. But Spilker, of the drug makers’ trade group, said these firms would self-destruct if they took that path.

“These companies would absolutely destroy their credibility with many communities if they were to break that faith,” he said.