New site makes it easier for patients to find clinical trials
BY SUSAN IPAKTCHIAN
People seeking information on clinical trials can search the new Web site four ways: by disease, investigator, department or free-text search.
Until now, if you wanted to find out about the types of clinical trials being conducted at Stanford, your only option was to type a few key phrases into Google and hope for the best.
But that will change on Nov. 9 with the launch of a single, comprehensive, publicly accessible database of the clinical trials at Stanford and affiliated facilities. The database will be available online at http://clinicaltrials.stanford.edu.
In addition to its value as a resource for researchers, the new registry will be a huge boon to patients hoping to find clinical trials that match their medical needs.
"The Web is increasingly used by patients and referring physicians as the primary mechanism to learn about clinical trials," said Harry Greenberg, MD, senior associate dean for research at the School of Medicine. "To date, finding comprehensive information about studies at Stanford has been extremely difficult. By providing a single, easy-to-use Web site, this system helps the public to more easily discover Stanford's studies."
At any one time, about 1,000 clinical trials are going on at Stanford, with about 300 trials beginning and 300 trials ending each year, said Steven Alexander, MD, medical director of the Stanford/Packard Center for Translational Research in Medicine, the organization that oversees Stanford's clinical trials. Current Stanford studies range from testing a new drug for leukemia, to assessing the impact of meditation on depression, to exploring a novel treatment plan for Hodgkin's disease.
Clinical trials are the proving grounds in which researchers assess the safety and effectiveness of drugs, surgical procedures, medical devices, behavioral treatments and dietary interventions. Most of the early testing is done in laboratory settings and in animal models before moving to the clinical-trial stage, in which human subjects are used. If the clinical trials indicate the treatment is safe and effective, the U.S. Food and Drug Administration usually approves it for use by the broader public.
The oversight of clinical trials has come under increasing scrutiny in recent years; concerns were raised that in some instances, information about privately funded studies was either altered or suppressed when the resulting data were negative. To build more transparency into the process, the International Committee of Medical Journal Editors implemented a policy in July 2005 requiring that clinical trials be registered in a free, publicly available database prior to enrolling patients. Scientists who don't register their studies cannot publish their results in ICMJE publications. By April 2007, more than 40,000 trials had been registered with the database maintained by the National Institutes of Health at http://clinicaltrials.gov.
Clinical trials entered into the new Stanford system will be automatically uploaded to the NIH database, Alexander said, so that investigators don't have to enter the information twice. In addition, information from Stanford's database can be easily shared with collaborating institutions—such as Kaiser and the Palo Alto Medical Foundation—and can also be published on departmental Web sites within the medical school.
The registry will contain all "interventional" clinical studies conducted at Stanford. Interventional studies are those in which the outcome of some type of treatment (drugs, surgical procedures, behavioral treatments) is assessed. Studies that are purely "observational" in nature—for instance, tracking the health and dietary habits of adolescents—do not have to be registered.
Patients looking for information about clinical trials will have four different ways of searching the Stanford database: by condition or disease, by investigator, by department or through a free-text search.
"This will allow patients to go to their primary-care physician and ask if a certain clinical trial might be helpful for them," said Alexander, who is also a professor of pediatrics.
Michael Halaas, who oversees Web and systems engineering for the medical school's Office of Information Resources and Technology, headed the collaborative team from IRT and SPCTRM that developed the database and Web site. In recent weeks, the team preloaded the Stanford trials from the NIH database so that researchers don't have to re-register them when the Stanford registry launches Nov. 9.
Henry Lowe, MD, senior associate dean for information resources and technology, said the database system was designed to allow the clinical trials information to be linked to multiple internal databases at Stanford in the future. "We are exploring the potential for linking clinical trials descriptions to faculty information in the school's Community Academic Profiles system, to our STRIDE clinical and translational research informatics platform and to the medical center's electronic health record systems," Lowe said.
Researchers who have questions about posting noncancer-related trials in the registry should contact Linda Walker in the SPCTRM office at 498-7425 or linda.walker@stanford.edu. Those with questions about cancer trials should contact Ellen DiNucci in the Cancer Clinical Trials Office at 725-2839 or edinucci@stanford.edu.
