NEW YORK -- Before a new treatment becomes available, researchers must recruit hundreds or thousands of patients to participate in clinical research trials. But finding these patients is often difficult. Many potential candidates are unaware of the studies or unable to participate due do logistical hurdles. As a result, patients miss out on opportunities for novel treatment approaches -- and beneficial new therapies take longer to reach the public.
In a new initiative, researchers at Weill Cornell Medical College (WCMC) and Cornell's College of Agriculture and Life Sciences (CALS) have teamed up to develop strategies to better understand and enhance patient participation in clinical trials. The project, called Improving Methods for Patient Accrual to Clinical Trials (IMPACT), is one of several recent efforts at WCMC to foster clinical research programs across the medical spectrum.
"Low patient accrual in clinical trials poses a serious problem for the advancement of medical science," said John Leonard, professor of medicine at WCMC, attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and co-leader of the study.
The time required to conduct clinical trials is widely recognized as a limiting step in moving novel treatments forward, Leonard said. For 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.
"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," said Katherine McComas, principal leader of IMPACT and assistant professor of communication at Cornell. "We will be using two proven approaches -- the model of Risk Information Seeking and Processing, 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."
IMPACT investigators will collaborate with The Leukemia and 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 Department of Communication.
"Our aim is to provide data-supported recommendations for strategies to improve the accrual of patients in clinical trials," said Andrew Dannenberg, also a co-leader of the IMPACT project, professor of medicine at WCMC and attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Future phases of the study will develop specific tools to better educate patients about clinical trials and break down common barriers to participation, Dannenberg added, "so that new therapies for many disorders can be more rapidly designed and evaluated in order to deliver their maximal benefit."