IMPACT: Increasing clinical trial participation

Before a new treatment for a disease like cancer becomes available, physician-researchers must recruit hundreds or thousands of patients to participate in clinical research trials.

Yet, too often, finding these patients is difficult, as individuals may be unaware of clinical studies, or logistical barriers may preclude participation. The result is that many patients miss out on opportunities for novel treatment approaches, and the development of new and improved therapies is delayed.

Addressing this vital issue is a unique and innovative collaborative study, known as IMPACT, for "Improving Methods for Patient Accrual to Clinical Trials." Two institutions -- Weill Cornell Medical College in New York City and the Cornell University College of Agriculture and Life Sciences in Ithaca, NY -- have teamed to develop strategies to better understand and enhance such patient participation in clinical trials.

"Low patient accrual in clinical trials poses a serious problem for the advancement of medical science," observes Dr. John Leonard, a co-leader of the IMPACT study, who is also professor of medicine at Weill Cornell Medical College and attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "The time required to conduct clinical trials is widely recognized as a rate-limiting step in moving novel treatments forward. As one example, less than 2 percent of patients choose to participate in clinical trials for cancer therapies across the United States. Even a modest increase of 2 to 3 percentage points would make a major impact, meaning the difference between completing a study in two years instead of three years -- and potentially resulting in thousands of lives saved if the standard of care is improved more rapidly. To this end, this unique collaborative study will seek to uncover new means for improving recruitment and better serving patients," he says.

"We're excited to strengthen the alliances between our two campuses while bringing together expertise in both medical and communication science to address important social issues. The IMPACT project is the start of what we envision as a long-term collaboration between our two groups. We envision that together we will use established communication research methods to promote health-related activities in numerous areas," says Dr. Geri Gay, another co-leader of the effort as well as professor and chairman of the Department of Communication in the College of Agriculture and Life Sciences at Cornell University.

IMPACT investigators will also collaborate with The Leukemia & Lymphoma Society, which has helped finance the first phase of the project, including a national survey on attitudes toward participation in clinical trials. The funding will also support a doctoral student in the Communication Department focusing in this area.

"Cancer clinical trials have brought enormous advances in the areas of cancer prevention, treatment and diagnosis. By encouraging broader and more rapid enrollment, the benefits of clinical research, including prevention and treatment, will be more quickly available to a greater number of patients," says Dr. Dwayne Howell, president and CEO of The Leukemia & Lymphoma Society.

"Hundreds of studies have sought to identify and overcome barriers to enrollment. This project is the first to assess the problem from a socio-psychological perspective, using the specialized methods of risk communication," says Dr. Katherine McComas, principal leader of the IMPACT study and assistant professor in the Department of Communication at the College of Agriculture and Life Sciences at Cornell. "We will be using two proven approaches -- the model of Risk Information Seeking and Processing (RISP) and Theory of Planned Behavior. These will allow us to examine specific factors that influence how patients inform themselves about a clinical trial and decide whether to participate."

Previous research has identified several barriers to enrollment, including patients' fears of randomization and risk of side effects; distrust of physicians and researchers; time commitment and other logistical concerns; and lack of familiarity with clinical trials. On the flip side, patients may choose to participate in clinical trials because they perceive potential for a better treatment (or for refractory cases, any treatment where no good alternative is available), reduced treatment cost and feelings of altruism.

The IMPACT project is one of several recent efforts at Weill Cornell Medical College to foster clinical research programs across the medical spectrum, including the development of the Institute for Clinical Research under the direction of Dr. Ralph Nachman, Associate Dean for Clinical Research at Weill Cornell.

"Our aim is to provide data-supported recommendations for strategies to improve the accrual of patients in clinical trials," adds Dr. Andrew Dannenberg, also a co-leader of the IMPACT project, professor of medicine at Weill Cornell Medical College and attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "Future phases of the study will develop specific tools to better inform patients, educate them as to the pros and cons of enrolling in clinical trials, as well as create strategies to facilitate participation so that new therapies for many disorders can be more rapidly designed and evaluated in order to deliver their maximal benefit."