Yale asks community to “help us discover” cures for disease

Yale University is launching a major effort to recruit thousands of volunteers to participate in clinical trials being conducted at Yale’s Schools of Medicine, Nursing, and Public Health. Posters, brochures, newspaper ads, radio spots, transit ads, and community health fairs will encourage members of the Greater New Haven community, including students, to enroll in the hundreds of trials that are initiated every year.

The campaign is called “Help Us Discover” because without community involvement, lab research cannot be translated into treatments. Clinical trials are necessary to test the safety and effectiveness of new, potentially life-saving treatments. “It’s how we get the new medications and other treatments that doctors prescribe every day,” said David J.  Leffell, M.D., deputy dean for clinical affairs and CEO of Yale Medical Group, who relies on clinical trials to bring cutting-edge new medications into his practice at Yale, which is focused on skin cancer and melanoma.

But recruiting volunteers for such trials is one of the biggest challenges now facing clinical researchers. In recent years, there has been a shortage of volunteers for many clinical trials, not just at Yale but at academic research centers around the world — particularly among minorities, adolescents, and cancer patients.

The mission of the Yale Center for Clinical Investigation (YCCI) is to facilitate the translation of medical discoveries from the lab to the patient community to improve care. YCCI was launched in 2006 to support clinical and translational research and training, and much of its work, including this recruitment campaign, receives Clinical and Translational Science Award (CTSA) funding from the National Center for Advancing Translational Sciences at the National Institutes of Health. To date, Yale has received more than $100 million in research funding through the CTSA.

For more information on clinical trials at Yale, go to http://www.yalestudies.org.

One of YCCI’s top responsibilities is recruiting and screening enough volunteers with certain medical conditions – or those in perfect health – to fill Yale’s many trials. “There is a lack of awareness that clinical trials are safe and essential to develop new treatments for a broad range of illnesses,” Leffell said.

“We hope to recruit thousands of healthy Yale students, faculty, and staff as well as healthy members of the New Haven community to fill the ‘control group’ quota in our trials,” said YCCI director Robert Sherwin, M.D., section chief of endocrinology at Yale School of Medicine. “Healthy volunteers are absolutely necessary for us to figure out the specific causes of a disease so better therapies can be developed in the future.”

Many people suffer from chronic conditions like diabetes, cancer, cardiovascular disease, and pediatric and geriatric illnesses, which are all being studied at Yale. Sherwin said that they could potentially benefit from enrolling in clinical trials. “People need to realize that if they participate in clinical trials they may be able to benefit from new drugs and medical devices now, while we are still in the research phase of development,” Sherwin explained.

To increase public awareness, YCCI is going all-out to educate the Yale and New Haven communities about how their participation in trials can help improve health care for everyone. To help increase the participation of the Hispanic and African-American populations in clinical trials, Yale has partnered with two “cultural ambassadors” – JUNTA for Progressive Action and the African Methodist Episcopal Zion (AME Zion) Church. The goal is to ensure that clinical trial participation reflects the diversity in New Haven and that it will benefit patients here and beyond. JUNTA is the oldest Latino community-based non-profit organization in New Haven, and the AME Zion Church is New Haven’s oldest African-American congregation.

One area of particular concern is diabetes. Sherwin and his Yale colleague William Tamborlane, M.D. were pioneers in the development of the insulin pump that is to this day used in the treatment of type 1 diabetes. “The development of the insulin pump was only the initial step in a 30-year journey of research into better care of diabetes at Yale that has now led to testing of the first prototypes of an artificial pancreas for patients with diabetes,” said Tamborlane, professor of pediatrics and endocrinology.

Leffell said he hopes people will realize that participating in clinical trials is safe, whether they come in as patients or as healthy volunteers. “There are many safeguards in place today,” he said, adding that he understands why some people may be suspicious of clinical trials because of unethical practices that took place more than half a century ago. Leffell acknowledged, “We have to talk about these difficult things with the community in order to ease their fears.”

YCCI’s ultimate goal with this recruitment campaign is to be able to bring the benefits of the research done at Yale to more people. When asked why anyone – healthy or sick – would want to participate, Leffell said, “Because most people understand that participation has the potential to help them, their children, and all of mankind. Clinical research is imperative to reach that goal.”