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.
Earlier this month, a number of Democratic senators called for the existing database to be expanded or replaced. They said pharmaceutical companies should be forced to register details about the opening of a drug trial and its results. Some industry officials, however, have said that such a requirement would compromise proprietary information.
The American Medical Association has also backed the drive for mandatory disclosure of clinical trials, voicing concerns that drug companies tend to flag positive test findings while playing down those with negative or inconclusive results.
Over the last two years, about 250 drug companies have registered with ClinicalTrials.gov, putting about 1,300 trials on the site, McCray said. She said she believes mandatory registration would lead to more effective research.
"It would go very far in ensuring transparency in the whole clinical research enterprise," McCray said. "If you knew that a particular trial had taken place, you could track down what happened, and you could do better meta-analyses and systematic reviews."
"I believe patients have the right to know what's going on, because after all they have volunteered to participate in such an experiment and have perhaps put themselves at risk."
McCray says she finds it hard to understand industry concerns about the possible loss of proprietary information.
"When a patient participates in a clinical trial, that information is out there," she said. "The level of information we put into our database is really, if you think about it, like an abstract of a research protocol. It is relatively minimal information in the overall protocol."
She points to cases such as that of her neighbor, Ellen Berty, to demonstrate how ClinicalTrials.gov is making a difference in the lives of those who may once have struggled to find reliable and concise information on medical trials.
"Before the site was established," McCray said, "you really had to know someone who knew someone to find out about a clinical trial, because the information was just scattered all over."