Leaders of the University and wider New Haven community rolled out a series of new initiatives last week aimed at increasing clinical trial participation.

The new initiatives come after two previous attempts at boosting enrollment, starting in January 2006 with the creation of the Yale Center for Clinical Investigation, launched to offer infrastructural and logistical support to clinical trial researchers. Five years later, YCCI began a cultural outreach program to tap into minority communities who have traditionally been less willing to participate in clinical trials.

This year’s push — which was launched last week — also emphasizes working more closely with community leaders to increase minority representation in clinical trials, using gift cards to reimburse patients and advertising clinical trials on MyChart. The proposals were informed through extensive surveys, interviews and focus groups, said YCCI Chief Operating Officer Tesheia Johnson.

“Support [for clinical trial participation] at my parish is growing because we are doing more than just asking people to sign up — we are engaging the community in a conversation,” said the Rev. Eldren Morrison, pastor of the Varick Memorial African Methodist Episcopal Zion Church.

According to YCCI Director and section chief of endocrinology at the Yale School of Medicine Robert Sherwin, although the University has a strong history of basic science research, it has placed less emphasis on clinical trials. Due to a lack of infrastructure and support staff, individual investigators have had to bear the logistical burdens of organizing participant recruitment and conforming to federal regulations. Over the past three to five years, YCCI has developed the necessary infrastructure to address those issues, Sherwin said.

Director of the Yale Cancer Center and Physician-in-Chief of Smilow Cancer Hospital Thomas Lynch ’82 MED ’86 said that the Cancer Center has not had to deal with the same issues as other research departments in the past because patients normally get involved in trials as part of the course of their treatment. In fact, he noted, YCCI struggles with the opposite problem — the demand exceeds supply. The therapeutic trials do not currently have room for everyone who wants to participate, but YCCI has still been able to increase participation in trials four-fold in the past six years. YCCI is trying to replicate those increases across the University.

Still, some groups have been harder than others to reach, said Dean of the School of Medicine Robert Alpern.

“The groups that have been the most difficult to reach are minorities,” Alpern said. “They have less trust in the medical establishment.”

He noted that not having many minority clinical trial participants makes it harder for investigators to be sure that particular drugs are safe for those minority groups, as drugs that are effective for Caucasians are not always as effective for Latinos, African Americans or patients of other races.

Johnson added that the delay between the discovery of promising medical treatments and those drugs going on the market is a direct result of difficulties in recruiting sufficient and varied participants for trials.

Sherwin acknowledged that the difficulty that the University and the country as a whole has experienced in recruiting minorities for clinical trials stems from a legacy of maltreatment in the medical establishment.

“Historically, minority populations have had concerns about how they will be treated in medical trials, and if people will be experimenting on them,” Sherwin said.

Morrison agreed that the distrust that the African-American community has of medical testing stems from past injustices, adding that would-be participants think they are going to be “guinea pigs” and are concerned that the drugs they are being given have not yet been proven to be safe. But Morrison and Sherwin said this view is no longer accurate.

“This was a problem historically, but is not a problem today,” Sherwin said.

Morrison added that minorities can be skeptical of offers of help from the medical community because they have not been granted the same access to healthcare as many of their white peers. He added that information serves as another obstacle to participation.

“A lot of people are skeptical because they don’t understand the language surrounding clinical trials,” Morrison said, explaining that many members of his parish did not know that they would be well-taken care of if they participated in a clinical trial.

He added that support for trial participation has been growing in the African-American community because YCCI has bridged the information gap. In addition to working closely with Junta for Progressive Action — a nonprofit working with the New Haven Latino community — YCCI has been working with the African Methodist Episcopal Zion Church to promote trial participation in minority communities.

Presently, information about upcoming clinical trials is advertised at Morrison’s church, with studies about stress and high blood pressure featured prominently on the parish noticeboard. Morrison explained that before any trial advertisement is posted, the church collectively decides with YCCI which trials the congregation would want more information about.

“The biggest issue we have is access to information, even before access to healthcare,” he said.

Johnson said that numerous events, including educational health fairs and talks about health issues not connected to medical research have been conducted in African-American and Latino communities to bridge the information gap. He added that the group has also developed informational materials that speak directly to minority populations’ concerns about clinical trial participation.

Morrison said individualized solutions to drawing in minority participation are the most important avenue for getting them to be involved. He noted that faith can also pose a barrier to trial participation among religious communities.

“There has always been the feeling in the religious community that people have so much faith, they think God is going to heal them, and they don’t take their medication,” Morrison said, adding that a more holistic approach would be thinking that God operates through doctors.

In addition to reaching out to the minority community, YCCI is now changing its method of reimbursement. Clinical trial participants will now be given refillable debit cards, as opposed to checks that take weeks to deposit into participants’ accounts. Johnson said that because trials reimburse people for expenses incurred to take part in the trials, such as parking meter fees, it is inconvenient for participants to wait for long periods of time to receive reimbursements.

Morrison noted that check reimbursement is particularly inconvenient for some members of his congregation, as not everyone has bank accounts.

Since YCCI’s launch in 2006, the center has received over $100 million in grant money from the National Institutes of Health.