Most of the time, Kelly Scott doesn't worry much about her daughter Bailey, an energetic 10-year-old who loves to ski near her family's home in Maine. But once a year, Scott remembers the day when Bailey, then a week old, had surgery to reverse the position of the two largest arteries in her heart. Bailey was part of a clinical trial at Children's Hospital Boston, and annual check-ups let researchers track her progress. Scott found out about the trial in the usual way - her doctors told her about it. "They didn't give us many choices," she says. "It didn't seem that there were any."

Today, things are different. When Scott wanted to know how Bailey was doing compared with other children in the study - information her doctor was reluctant to share - she went to ClinicalTrials.gov <http://ClinicalTrials.gov>, a database launched last year by the National Institutes of Health (NIH). Although it was difficult for her to read mortality statistics about children who began life just as Bailey did, Scott says, "I would rather know."

ClinicalTrials.gov, an ambitious scheme funded by the federal government, could open the world of drug trials - a byzantine network of research hospitals, drug companies, private physicians and government agencies - to the public. Alexa McCray, the project's director, predicts that it will fundamentally change the doctor-patient relationship. "My hope is that it will be more of a partnership," she says, once patients know more about their treatment options. Whether or not McCray succeeds will depend on drug companies' willingness to share jealously guarded research and patients' readiness to take a more active role in their own treatment.

Until now, lack of access to information about drug studies has kept people from enrolling and possibly getting the help they need. "Only about 3% of adults with cancer participate in clinical trials," says Dr. Ted Gansler, medical editor for patient information at the American Cancer Society. "That number should be at least 10%." In 1997, though, the Food and Drug Administration Modernization Act was passed in response to lobbying by patients' rights groups; this act calls on the government to build a database of clinical trials that will tell patients who is eligible for a given trial and which institution sponsors it. The law says nothing about the Web, but McCray and her staff at the National Library of Medicine, an arm of the NIH, chose a broad interpretation and went to the Net.

So far, ClinicalTrials.gov <http://ClinicalTrials.gov>includes 5,200 listings of studies seeking treatments for everything from autism to sickle-cell anemia, and about 5,000 people check the free site every day. Patients can search by condition, location and age group to find trials for which they may be eligible, and they do not need to submit any information about themselves. Most of the listed trials are sponsored by the 21 research centers of the NIH, but there are also some from drug companies, teaching hospitals and private foundations.

To become truly comprehensive, however, ClinicalTrials.gov <http://ClinicalTrials.gov>will need greater cooperation from private drug companies. McCray estimates that their research could triple the number of trials in the database, but so far the pharmaceutical industry has been unwilling to sacrifice proprietary information for the sake of patient access. "Even the name of the study and the hypothesis and the name of the investigator - that pretty much tells everybody else in the industry what you're doing," says Larry Hirsch, a spokesman for Merck Research Labs.

Drug companies simply have nothing to gain from ClinicalTrials.gov <http://ClinicalTrials.gov>, according to Nancy Roth, director of clinical strategic planning and operations for Bristol-Myers Squibb. Unlike the NIH, which relies on doctor referrals and self-referrals to recruit subjects, drug manufacturers have the money to reach patients through advertising or directly through doctors. McCray, the FDA and the drug industry are trying to hammer out a compromise that would allow companies to reveal limited information about their tests. Ideally, McCray says, drugmakers would submit data for ClinicalTrials.gov <http://ClinicalTrials.gov>along with new drug applications to the FDA. But so far, the industry has insisted that the law requires such data to be submitted only for "serious or life-threatening illnesses," such as cancer or AIDS.

ClinicalTrials.gov <http://ClinicalTrials.gov>is not the only resource for patients who need such help. TrialsCentral <http://www.trialscentral.org>, a nonprofit effort, includes dozens of links to other trial listings. The for-profit group CenterWatch <http://centerwatch.com>runs a site to which companies voluntarily submit information, so the listings often do not include details about the drug or its sponsor. Myrl Weinberg, president of the National Health Council, a coalition of 50 patient-advocacy groups, says she hopes the NIH will take CenterWatch's example. If asking for proprietary information prevents drug companies from giving any data at all, Weinberg says, "we would support not asking for it."

Regardless of how successful ClinicalTrials.gov <http://ClinicalTrials.gov>proves to be, patients can no longer afford to ignore online information about clinical trials - doctors actually expect them to be informed. "Patients have much more time than we do to search for things," says Dr. Jeffrey Raizer, attending neurologist at Memorial Sloan-Kettering Cancer Center in New York City. Even if they have the information, doctors may be reluctant to enroll patients in a trial unless they have exhausted other treatment options or the patient makes a specific request. "It's a lot of work for the doctor," says Dr. Barry Kaplan, director of medical oncology at New York Hospital Medical Center of Queens. "Why would he want to do it?"

Perhaps because a clinical trial can be a patient's only hope. ClinicalTrials.gov <http://ClinicalTrials.gov>may not be a perfect solution: even Dr. John Gallin, director of the NIH Clinical Center, says that depending on the Web to disseminate medical information denies access to more than half of the U.S. population and to two-thirds of African-Americans (who are already underrepresented in clinical trials). Nevertheless, putting this vital information in one central place could be an important first step.

April2001

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