Standing next to an ophthalmologist, children with the eye disorder amblyopia lean over a computer and click on an icon.
In seconds, they know whether their treatment will be a patch that might bring comments from friends or atropine drops to blur their vision. Going to the doctor has never seemed quite so much like a real-life video game.
"It is fun," says Pamela Moke, director of systems development at the Jaeb Center for Health Research in Tampa, Fla.
The children, participating in a clinical trial to test the efficacy of two treatment options, are using a Web site the Jaeb Center set up to manage the trial. The site randomly assigns a mode of treatment.
"Web sites make clinical trials very efficient," Moke says. Community-based physicians use Jaeb's sites to communicate with the center, read study protocols and print out customized case report forms that already have their patient information on them.
The Jaeb Center is on the forefront of using the Internet and other electronic tools to conduct clinical trials, says Richard Mowery, special assistant for clinical research and bioethics at the National Eye Institute in Bethesda, Md., one of the National Institutes of Health. The NIH, which doles out billions of dollars in clinical study grants each year, encourages investigators to design new ways of recruiting patients and conducting clinical trials, including using the Internet, Mowery says.
Yet of the estimated 10,000 clinical trials that are open at any given time, just a small number--about 10%--utilize the Web and other forms of electronic data capture, experts say.
That is changing as pharmaceutical companies, the government and clinical sites realize the advantages of using the Internet and software designed for clinical trials. Cost savings are one benefit. A two-year clinical trial with 2,000 patients can cost a pharmaceutical company $11.4 million to run. Electronic data capture tools can reduce that by more than $750,000, according to Forrester Research of Cambridge, Mass.
The industry is beginning to embrace three different computer technologies, says Amith Viswanathan, a senior analyst in the healthcare information systems division at Frost and Sullivan, a San Antonio-based consulting and research firm. They are:
- e-recruitment, or using Web sites to recruit patients to participate in clinical trials;
- electronic data capture, in which investigators fill out electronic case reports to document care during a trial; and
- electronic patient diaries, which enable patients to answer questions about response to treatment on handheld devices or the Internet.
In e-recruitment, the Internet has been instrumental in making consumers more aware of clinical trials, Mowery says.
At www.clinicaltrials.gov, an NIH site that lists all government-sponsored trials and contact numbers, more than 2 million hits are logged per month, representing about 5,000 new users per day. Many commercial sites also list trials sponsored by the pharmaceutical industry and private organizations.
Boston-based CenterWatch, for example, lists about 41,000 trials at its site, www.centerwatch.com.
Five million consumers have recently looked for information on clinical trials online, according to Cyber Dialogue, a New York-based Internet research and consulting firm. Searchers most often are looking for information on cancer, obesity and diabetes, all areas where a high number of trials exist.
Researchers have a golden opportunity to recruit those consumers into studies, says Mark Bard, director of Cyber Dialogue's health practice. "The Internet helps play matchmaker in ways that were not possible before we had such a shared medium used by half of the adult population."
Yet e-recruitment faces many challenges.
Geographic barriers have hindered online recruiting for the Office of Clinical Research and Training at Northwestern University in Chicago. The multispecialty center recruits patients for about 20 clinical trials each month. It has posted trial information on its Web site and outside recruitment sites for several years, but less than 1% of its recruits come from online leads, says recruitment manager Peri Todd.
Privacy also is a concern. Consumers looking for information on clinical trials on the Internet should read privacy policies at each site, says Janlori Goldman, director of the Health Privacy Project at Washington's Georgetown University.
Keeping clinical trial data secure on the Internet also is a concern when clinicians use electronic data capture tools.
Privacy also is being watched by the Food and Drug Administration, which regulates clinical trials, according to Rebecca Kush, president of the Clinical Data Interchange Standards Consortium, a not-for-profit organization working to create standards for exchanging clinical trials information electronically.
Growth in electronic data capture will be significant over the next several years, consultants say. Thirty-four percent of clinical trial professionals expect to use Web-enabled systems for between 10% and 20% of their trials in 2003, while 4% expect to use such tools for 90% to 100% of trials by then, according to a Forrester Research survey of 400 people in the field.
For physician practices, however, using software that automates the collection of clinical trial data poses problems even as it solves others, Kush says.
Because trials can be performed by single practitioners as well as large clinics or physicians in university settings, the difference in available technology such as high-speed Internet connections varies greatly.
Typically, pharmaceutical companies or private sponsors provide the electronic tools to physicians, even setting up Internet access if an office does not have it. Study sponsors usually pay for such tools in addition to providing drugs, paying physicians fees of about $500 to $5,000 for each patient and covering other expenses. They often provide software via an application service provider or a third-party company that operates the trial's software and databases.
But offices have to enter the data, which can take more time than filling out a paper form. They also can end up with a half-dozen or more systems, sometimes on separate computers, depending on the number of studies they are in.
The upside, Kush says, is that such software is designed to catch mistakes. That saves time in the long run. Errors on paper can take hours to fix if a study sponsor has to send forms back to be corrected later.
Collecting data electronically also gives study sponsors immediate access to treatment data that they now must wait weeks to see if the researcher is using paper records, says Paul Bleicher, M.D. Bleicher is founder and chief scientific officer at Phase Forward, a Waltham, Mass.-based vendor of electronic data capture software for clinical trials.
Conducting trials electronically can save months at the end of a study, says Eric Hoffman, director of the office of clinical trial management at The Ludwig Institute for Cancer Research in New York.
"Now we can view data, ask questions and get answers in real-time," Hoffman says.
