A national program to streamline the recruitment of volunteers for biomedical clinical trials has been launched online by the National Institutes of Health, the primary federal agency charged with supporting and developing medical research in the United States.
People who want to participate in approved clinical trials can log on now to ResearchMatch.org and self-register. Beginning in January, researchers looking for volunteers will be able to review their personal profiles and send them an e-mail message through ResearchMatch — initially, without knowing the volunteer’s name, address or phone number.
If, after the initial message, a prospective volunteer wants to release his or her contact information, the researcher might provide more specifics about the study and ask the person to complete a survey at home, go to an outpatient clinic or travel to a research hospital. There is no obligation to participate.
Since the ResearchMatch Web site went up Nov. 10, about 2,300 volunteers from 48 states have registered, organizers said. The program is aimed primarily at medical research but is open to researchers in the social sciences as well.
“ResearchMatch offers a convenient solution to the complex, competitive and often costly participant recruitment system,” said Gordon Bernard, a principal investigator for the Vanderbilt Institute for Clinical and Translational Research, in Nashville, Tenn., which is hosting the national registry. “NIH data indicates that 85 percent of trials don’t finish on time due to low patient participation, and 30 percent of trial sites fail to enroll even a single patient.”
The NIH invests more than $28 billion in medical research yearly. Most of the funding is awarded through 50,000 competitive grants to more than 325,000 researchers, working at more than 3,000 universities, medical schools and clinics, in every state and around the world.
Yet studies show that only 4 percent of the U.S. population has ever participated in a clinical trial. According to a 2008 survey by the Society for Women’s Health Research, 94 percent of Americans say their doctors have never referred them to a medical study.
In fact, finding volunteers is the most difficult part of clinical trials, said Steven Alexander, a pediatric researcher who directs the compliance and training programs for clinical research at the Stanford University School of Medicine in Palo Alto, Calif. Stanford and Vanderbilt belong to a network of 52 hospitals and universities supporting ResearchMatch.
It is particularly hard to find volunteers in pediatrics because serious disease is uncommon in children, Alexander said. He recalled how, several years ago, a study that he helped conduct on children with kidney disease was inconclusive because he and his colleagues could not find enough participants.
“The question was whether a protein-restricted diet could reduce the rate of kidney-function deterioration in children,” Alexander said. “You start the study, you get it going, you spend the money, and then if you don’t have enough subjects, you end up not answering your question. You don’t have enough information to say that whatever you saw was a significant result. It means it could have happened by chance.”
Some researchers have resorted to running ads in newspapers and on Craigslist and even putting up posters in elevators to get the word out, Alexander said.
“We’re not down to Twitter yet, but we’ve used just about everything else,” he said.
For volunteers trying to connect with clinical trials, it can be like looking for a needle in a haystack, too. Stanford gets hundreds of calls from very sick people who are trying to hook up with researchers, but with 1,000 active studies under way at its School of Medicine, it’s difficult to find the right matches, Alexander said.
ResearchMatch is being billed as the first nonprofit initiative in the U.S. to put researchers in touch with a “disease-neutral” database of prospective volunteers. It places the burden on the researcher to find volunteers who fit their studies, instead of the other way around. It is designed to complement ClinicalTrials.gov, an NIH initiative that asks volunteers to pick the trials that might work for them.
“Instead of having the volunteer spend a wealth of time looking and searching for the right match, researchers with approved studies will be able to search the registry for potential matches,” said Kirstin Scott, the program manager. “It’s a pool of interested volunteers. There is no disease prerequisite. You can have breast cancer, asthma, cardiovascular conditions or a rare disease — or you can be perfectly healthy. A family could register on the site.”
Typically, people seek to join a clinical trial in order to obtain free access to a drug or medical treatment that they could not otherwise afford, or to participate in an experimental program, not yet approved for general use, that they believe might cure their disease. They may want to help researchers find a cure for a family member who is afflicted. They may be healthy and simply committed to moving medicine forward.
“There are truly altruistic people who are determined to be on the team,” Alexander said. “Or they have a serious medical problem and are looking for the most advanced treatment. There’s a lot of good medicine that can be done in the setting of clinical research.”
Childhood leukemia is now a curable disease because a lot of determined people volunteered their children for clinical trials, and doctors were able to learn more about the timing and use of already existing medications, Alexander said.
“It is the great success story of clinical research,” he said. “Childhood leukemia was cured by clinical research. It wasn’t the silver bullet of some wonderful medicine.
“Every child with leukemia now is a part of a study. I think that’s the model for all of us. It is like a mission. It is the only way.”
The 52 institutions supporting ResearchMatch are affiliated with the Clinical and Translational Science Awards, a national network of medical research institutions working to improve the way medical research is conducted across the country. All researchers must submit their studies to a review board for approval before soliciting volunteers.
