Advocate for Access to Medical Data

Linguist Wants Patients to Understand

Ellen Berty first stumbled across the ClinicalTrials.gov Web site while researching treatments for the Type 1 diabetes that has dogged her since the age of 13. Months later, after receiving an islet cell transplant in a clinical trial at the National Institutes of Health, she couldn't wait to tell her neighbors about the Web site that had pointed her in the right direction.

"All the information I needed was there on the site; I didn't have to go anywhere else," she said. "One day, I was telling my neighbor Alexa how I found out about the trial, and she just looked at me and said, 'Ellen, that's my project.' "

ClinicalTrials.gov was the brainchild of Alexa McCray, director of the Lister Hill National Center for Biomedical Communications, an intramural research division of the National Library of Medicine at the National Institutes of Health. Taking the lead from the Food and Drug Administration Modernization Act 1997, which called for the establishment of a clinical trials registry that would be available to the public, McCray turned to the Internet to ensure an accessible and user-friendly resource for everyone from patients to health care professionals.

Since its inception in February 2000, the federally funded database has been embraced by millions of people trying to pick their way through the often byzantine world of clinical trials.

"When we launched, we had information on around 4,400 trials, most of which were federally sponsored trials," McCray said. "Today, we have around 11,100 trials, which include those carried out by NIH, other federal agencies and private industry. We have about 3 million page views per month, which is quite a lot for a specialized resource. On any given day, we can have anywhere between 14,000 and 16,000 unique visitors to the site."

ClinicalTrials.gov today is receiving an Innovations in American Government Award, along with another federal program, the Justice Department's Performance Standards for Juvenile Corrections. The awards are a program of the Ash Institute for Democratic Governance and Innovation at Harvard University's Kennedy School of Government, and they are administered in partnership with the Council for Excellence in Government. The winning programs receive a $100,000 grant for further development.

"The old saying is true. Information is power -- and ClinicalTrials.gov provides trusted and empowering information to people facing life-threatening illnesses," said Gowher Rizvi, director of the Ash Institute.

In addition to getting detailed information on the location of clinical trials, type of treatment and criteria for participation, users of the free site can also access links to further online health resources, such as Medlineplus and PubMed.

Listed studies vary from those taking place in all 50 states to tests in more than 90 countries worldwide.

Having trained in linguistics, McCray is a strong advocate of distilling complex medical terminology into simple, everyday language to ensure that prospective patients are able to make informed choices after weighing the benefits and risks of taking part in medical trials.

A glossary of common terms, a list of frequently asked questions and the site's "spell check" technology help the user sift through the information in the data bank.

"I really believe that patients have the right to this kind of information, whether it's clinical trials data or the latest literature on medical breakthroughs or just getting a better understanding of some condition that you or a family member suffers from," she said.

"We really view this as increasing and helping the partnership between the health care provider or doctor and the patient."

The registry is not without its critics, however, with some highlighting the limited scope of the database, particularly when it comes to clinical trials carried out by the private drug industry.