Involving the community in cancer clinical trials

IRBs, others can improve community participation

More meaningfully involving communities – especially minorities and other ethnic groups – in clinical research isn't just good ethics — it could help address under-recruitment and failure of cancer clinical trials, says one of the authors of a new report on the subject.

"One of the more compelling issues that came up in the course of this project is how many cancer clinical trials closed without having enough enrollment in the study to actually complete it," says Sarena D. Seifer, MD, research associate professor at the University of Washington School of Public Health and Community Medicine in Seattle. "If resources go into getting studies designed and opened and then they close because they can't get enough enrollment to actually complete the study, that's a tragedy and a waste of resources."

Seifer's group, Community-Campus Partnerships for Health (CCHP) along with the Education Network to Advance Cancer Clinical Trials (ENACCT), recently released the report "Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy," which was funded in part by the National Cancer Institute, the Agency for Healthcare Research and Quality (AHRQ).

The report looks at community involvement throughout the cancer clinical trial process, and finds room for improvement at every step. In its 58 recommendations, the report challenges:

—Sponsors and investigators, both locally and nationally, to include a greater community voice in the design of cancer research, through the use of community representatives and patient advocates;

IRBs to increase the number of community members on their own boards and to challenge investigators to connect with the community;

—Those involved in research to develop better plans for distributing the results – in an understandable way – to the communities that participate in them.

The group also is offering seed grants of up to $8,000 to partners who implement some of the recommendations.

New hope for progress

Seifer says that while community researchers have promoted these goals for years, she now sees new impetus for change. She notes that the new Clinical and Translational Science Awards (CTSA) program focuses on community engagement in research.

"Until that initiative, there had been NIH funding for community-based research, but it was pretty small amounts of money, very isolated little efforts," Seifer says. "This is now part of a major re-haul of clinical research, so it's got a lot of investigators looking at these issues in a way that they might not have looked at them before."

In addition, she says, the Council of Public Representatives of the National Institutes of Health has become more vocal about community involvement in clinical research. And communities themselves are increasingly setting up boards to act in their own interest when approached by researchers.

"We found more than 100 community groups around the country that have put in place some IRB or IRB-type mechanism to be able to vet research," Seifer says. "I think more community groups have wised up to the fact that they have power in this relationship and there are legitimate questions they need to be asking about what research gets done."

Seifer says despite the complexity of many cancer clinical trials, there still are vital roles for community members to contribute:

—They can help researchers figure out better ways to advertise and recruit participants for studies, steering them toward existing forums in the community, appeals to church leaders, or connecting with community health centers that serve underserved populations.

—They can participate on IRBs, giving their insights into the potential risks and benefits to people in the community, helping ensure that informed consent is understandable and making presentations to the community about research involvement.

—When the study is completed, they can help researchers come up with ways to disseminate findings to the community in an understandable way.

"How do you reach people so that not just the clinicians understand it, but people with the disease and their family members?" Seifer says. "Having community groups around the table – patient advocacy organizations, support groups, those sorts of folks – they can come up with ways to reach their peers in lay language."

Interest is there

Seifer says many representatives of community organizations, even those who had been involved with cancer prevention public health efforts, didn't know about existing opportunities to be a part of clinical research.

"Having them realize there's this whole clinical trial enterprise that's currently not very community engaged, they wanted to become a part of it," she says. "That really impressed me, because many people ask 'Where are we going to get these community people? Are they even interested?'

"I think they are interested in research that is going to be useful and going to be used."

[Editor's Note: For more information on the report "Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy," including specific recommendations and resources for IRBs, as well as details about available seed grants, visit the web site ]