by Deborah Borfitz

Finding clinical research studies can be a chore for would-be participants, even Internet-savvy ones who know how to utilize search engines for the task. To Google one’s way into the main Web site of university-based health systems, where much of the research takes place, is easy enough. It’s a haphazard journey from there. The search term “research” is as likely to turn up something on engineering as it is diabetes. The term “clinical research” might produce listings of studies involving human subjects, but those specific to cancer will be on a separate Web site from those specific to heart disease or arthritis. Studies on many types of medical conditions won’t be listed at all.

To expedite the search, the University of Michigan Health System (UMHS) in Ann Arbor recently launched a Web site that provides one-stop public access to recruiting studies taking place around the University of Michigan (U-M). Known as Engage (umengage.org), the site allows community members with any medical condition – as well as healthy volunteers – to search for studies that need people like them, says Dorene Markel, program director of the Center for the Advancement of Clinical Research, part of the University of Michigan Medical School. The site also includes general information on how clinical research studies work and how U-M ensures that study participants are protected from harm. In the near future, visitors to the site will have the option of filling out an online subject registry form indicating that they want to be considered for future studies.

University health systems have a vested interest in connecting people to clinical studies. “Many, many studies never reach the number of subjects needed to achieve a targeted statistical value because suitable volunteers are hard to find,” says Markel. The result is wasted time, effort, and money “not only for the research team, but also for the sponsor and people who did participate.”

The shortage of clinical research participants is due in part to ever-larger studies required by the U.S. Food and Drug Administration in order to bring a new drug to market or trumpet a new use for an older medication, says Markel. There is also a considerable amount of misinformation and fear about what it means to be a study participant. Some studies require overnight stays in the hospital and frequent tests and blood draws, making participation inconvenient and possibly uncomfortable. Many other would-be participants don’t think about, or are wholly unfamiliar with, clinical research and how important public involvement is to a project’s success.

Those who decide to participate in a study do so for a variety of reasons. Their current medication isn’t working well, for instance, or they want free medication and care. Many volunteers want to help further science. Others have exhausted other treatment options. Their challenge is where and how to look for a clinical research study. “Even within our own health system, doctors [in a position to refer patients] don’t necessarily know a colleague down the hall is doing a study their patients may be eligible for,” says Markel.

Complementary initiatives
Engage was launched internally two months before postings went up for public viewing in October, Markel says. That provided time for researchers to write narratives describing their studies and U-M’s institutional review board, which is responsible for ensuring studies comply with federal regulations, to begin approving the postings as accurate and non-coercive. Less than 100 studies were initially listed on Engage, with many more in the queue awaiting review board approval. The backlog was expected to be cleared up by mid-November. Markel estimates that there will be 300 to 400 listings once a marketing campaign is in full swing and more researchers recognize the site’s value in reaching subjects. Although U-M has more than 1,000 clinical studies active at any one time, some are no longer recruiting participants and others are at the data analysis stage.

To prevent someone from posting an “artificial study,” clinical research investigators are required to use their university security passwords, which give them access to an online template to describe their particular study or “protocol,” says Markel. The write-up is then transmitted to the institutional review board for review, a process that typically takes two to three weeks.

Listed protocols are automatically checked against a centralized data warehouse of review board-approved studies to ensure Web site visitors don’t see listings for studies that have ended or were closed because of patient safety or other concerns, says Markel. Most other trial-listing Web sites have outdated postings, as U-M once did.

Listings come primarily from the medical school, but the schools of public health, nursing, dentistry, and pharmacy are also being allowed to post studies. At least half of the studies are sponsored by the National Institutes of Health (NIH). The rest are funded by pharmaceutical companies.

A U-M programmer is currently working on a subject registry to complement the trial listing. “To get to a study, people have to contact a study coordinator listed in an Engage posting,” says Markel. “In the future, they’ll have the option to complete a registry form online.” Among the questions will be whether they’re interested in that one study only or if they’d also consider future studies. For registrants to be matched to a research study, they’d need to provide basic demographic information and indicate if they’re taking medications or have been diagnosed with a disease. To help ensure people are who they claim to be, the form will ask UMHS patients to give permission for the information they provide to be checked against their medical record. Data in the medical record would also be used to more effectively match people to studies, since many factors – including certain co-morbid conditions, current medications, and addictive behaviors such as smoking and drinking – may automatically exclude people from consideration for some studies.

Engage will dovetail with a new e-research initiative launched university-wide that streamlines the internal review process for all studies involving human subjects. Investigators can now go to a single portal to fill out an electronic form that answers questions heretofore asked multiple times by various ancillary review committees. “Investigators enter information one time,” says Markel, “and communication between the investigator and a committee is transparent to all other committees, so [investigators] don’t get conflicting requests.” After the next revision phase of the e-research project in the spring, investigators will also be able to fill out a single electronic form offering a “lay description” of a study for both the institutional review board and Engage.

Few glitches
Within two weeks of Engage’s public launch, research project managers were reporting “unsolicited calls from study coordinators that they were getting fantastic results already,” Markel notes. A formal assessment of the Web site’s recruitment value is being planned. A two-question survey that precedes each study search will also allow tabulation of the number and type of unique site visitors – physicians, staff members, students/trainees, patients, or community members.

Major stories about Engage appeared in the Detroit News and Ann Arbor News in advance of the launch. An ambitious marketing campaign is expected to drive additional traffic to the site. “The goal … is not only to create awareness and encourage people to visit the site, but also to increase awareness of the important role that volunteers play in the clinical research process,” says Maria White, lead marketing representative in the medical school’s office of public relations and marketing communications. “The take-away message is that it’s easy for just about anyone to get information or find a study … by visiting umengage.org.”

Posters have been distributed throughout the health system as well as mailed to 1,500 community organizations. Three versions of the poster have been produced, each showing a “slice of life” image portraying everyday people getting involved in clinical research in the hope of helping someone they love.

One poster features a college student hovered over his laptop in a Laundromat. With Engage at his fingertips, he’s researching his brother’s autism. Another pictures an elderly man walking down a hall with a little girl. The man is participating in a study in hopes of helping researchers learn more about cancer prevention for the sake of future generations. In the third poster, a young girl and her father are sitting at the dinner table. The girl is eating a large forkful of spinach, with the poster saying that the father not only makes sure his daughter gets her vegetables, but he’s also trying to make sure she doesn’t get Alzheimer’s disease, which took his father’s life. Each poster has a tear-off pad whose pages feature the Engage Web site address and the health system’s toll-free TeleCare number for accessing the same information by telephone.

Ads, which are based on the same creative concepts as the posters, have also begun appearing in local newspapers and university publications. Newspaper ads specifically recruiting clinical research subjects will have a common look and thus better visibility, says Markel. A U-M fax service used by physicians across Michigan and northern Ohio and Indiana to stay abreast of happenings at the university has also been used as a marketing vehicle for Engage. Information about the Web site will continue to appear as a crawl on the Weather Channel during certain segments. Online marketing, thus far, has been limited to an advertisement on a Michigan-specific Web site known as MLive.com. Local radio spots will begin airing next year. The Engage marketing campaign is expected to cost $100,000 the first year, according to Markel.

Markel says that there have been surprisingly few glitches since Engage was launched. A concern about the site excluding the poor and less educated, who aren’t as likely to have Web access, is being addressed through TeleCare. To encourage participation in clinical research among under-represented groups, extra online information will be available on a minority community page under development by the UMHS program in multicultural health and the medical school’s diversity and career development office.

Other recruitment sites
In developing Engage, UMHS reviewed five other academic medical centers that list clinical research studies on their Web sites.

University of Virginia Health System. Its clinical trials Web site (http://healthsystem.virginia.edu/internet/clinical_trials) has an enormous listing of studies, searchable by type (adult or pediatric), doctor, and 25 medical areas. For frequent visitors, there’s a link to all newly posted clinical trials.

Mayo Clinic. Its research volunteer program (http://clinicaltrials.mayo.edu/?CFID=5611576&CFTOKEN=36093063) gives visitors the option of viewing all clinical trials or searching by one of 10 subjects, such as “brain and nerve” or “infectious disease.”

Massachusetts General Hospital. At CRnet (http://crnet.mgh.harvard.edu/home/home.asp), the Harvard-affiliated institution lists trials in 38 therapeutic areas, from acupuncture to women’s mental health, conducted at Mass General, Brigham and Women’s Hospital, and other Partners HealthCare System institutions. Visitors can also register online for the organization’s research study volunteer program, called RSVP for health, to receive information about research studies.

University of Washington. To find studies conducted at its health science schools (http://www.washington.edu/healthresearch), visitors can either search postings seeking healthy volunteers or those investigating specific diseases or conditions. They can also find studies doing a text-based search using their own words.

Washington University. Its volunteer for health program (http://vfh.wustl.edu) lets visitors search research studies in 32 categories. To participate in a study, interested volunteers are asked to register online or print and mail a general health questionnaire. Those who meet the initial criteria are contacted by the investigator or study coordinator to provide further information and arrange for screening tests to establish eligibility.

Started in 1998, Washington University’s program is perhaps the best developed recruitment site. “The database was originally populated with 3,000 diabetic subjects from an original study database belonging to … an endocrinologist here at Washington University who is very involved in research,” says program director Sally Anderson. Another 21,500 study volunteers have since registered to be in the database. A total of about 8,500 e-questionnaires have been received since that capability was added in March 2000. In May 2005, online registration became interactive and volunteers could access the database to update their demographics and medical history at any time. In the six months thereafter, 1,015 online questionnaires were received, Anderson adds.

To date, the program has made over 49,000 referrals. In June 2003, feedback from study coordinators became a condition for receiving future referrals, Anderson says. Since that time, the program has documented that 13,000 subjects have been screened and 8,663 have been enrolled in studies.

Pleasing to NIH
“Engage, and Web sites like it, will become important mechanisms of reaching [members of] the public and getting them involved in research as participants as well as advisors and partners,” says Markel. One key reason is that NIH, which is the primary source of government funding for clinical research studies, is encouraging those types of interactions in its funding applications.

“From its inception, Engage was designed as a partnership between university researchers and individuals in the community who might be interested in participating in research,” says Daniel J. Clauw, MD, director of the Center for the Advancement of Clinical Research at University of Michigan Medical School. “Many new NIH initiatives … encourage investigators and institutions to develop these types of ‘community outreach’ programs.” In fact, NIH is awarding $30 million to a half-dozen institutions next year to develop professional interest in research and ensure new knowledge gets translated into clinical practice.