What strategies work effectively in reaching full enrollment in clinical trials? That was the question addressed at a 1½-day symposium held in Bethesda, Maryland, last April. With a limit of 300 participants, many who wanted to attend had to be turned away. "There was tremendous enthusiasm for the conference among investigators at both academic medical centers and community sites," said Neal J. Meropol, MD, from University Hospitals Case Medical Center and Case Western Reserve University, one of four cochairs of the event.

The "launch pad" for the NCI-ASCO Cancer Trial Accrual Symposium: Science and Solutions, according to Dr. Meropol, was the premise that everyone understands what the barriers are. With that as the foundation, the symposium focused on empirical research that had tested ways to overcome obstacles to clinical trial enrollment. "This was the first national meeting in which the explicit focus was on solutions to barriers in clinical trial recruitment," he pointed out.

Successful Strategies Presented

Representatives from sites actively engaged in clinical trial recruitment presented research and interventions that had enhanced accrual among a variety of patient populations and types of trials. In breakout sessions, research was presented about specific aspects of accrual, such as recruitment planning, community outreach, leadership, organizational culture, and minority recruitment.

"I was excited to see some of the successes that organizations had by using strategies with doctors as well as patients," Dr. Meropol said. As an example, a three-pronged approach used successfully at Ohio State University Comprehensive Cancer Center (OSUCCC) involved interventions with patients and family members, referring physicians, and the faculty and staff of the cancer center. During the 4-year period 2004-2007, accruals to therapeutic clinical trials had stagnated at about 700 accruals each year. To counter this, OSUCCC developed a campaign called "2010 by 2010" with the ambitious goal of enrolling 2,010 patients during the year 2010. Using a variety of strategies, including staff and faculty training, new communication methods with patients and referring physicians, and revised management systems in the Clinical Trials Office, annual patient accrual at OSUCCC has already increased 69% and is on track to exceed its goal for the year 2010 by 695 patients.

Commenting on the OSUCCC experience, which was one of four presented in a plenary session at the symposium, Dr. Meropol said, "The notion that institutional culture plays a big role in accrual success really resonated with the participants at the symposium."

He identified several take-home messages that emerged at the symposium:

• Site-specific applicability: Some interventions are more appropriate and effective in the community, whereas others work better in academic medical centers.
• Awareness: Any steps that improve awareness about clinical trials among communities, physicians, and patients can be useful.
• Organizational culture: Any changes to institutional culture that promote the importance of clinical trials among stakeholders at all levels can be helpful.
• Infrastructure: Basic changes in clinical trial infrastructure are needed to decrease impediments to physicians and patients to participate in clinical trials. Such infrastructure changes may include increased reimbursement to cover administrative costs of participation, wider insurance coverage for patients, and reduction in regulatory and paperwork requirements.
• Recruitment planning: In planning a clinical trial, more attention should be given to developing recruitment strategies and making sure that eligibility requirements are applicable to the patients seen in routine practice.

Dr. Meropol noted that funding for clinical trials was not addressed, in that it was outside the scope of the symposium.

Disseminating Results and Next Steps

A report summarizing the findings of the meeting is being prepared for submission to a cancer-related journal, Dr. Meropol stated. The document will incorporate literature references for the reader to refer to in developing accrual strategies. The success of the symposium has also generated enthusiasm for having similar meetings in the future, perhaps every other year.

One of the goals of the meeting was to identify recommendations for future research about accrual. To that end, each breakout group identified specific topics related to clinical trial accrual for which more research is needed. The report of the symposium will include recommendations for a research agenda related to clinical trial recruitment.

Slides presented at the meeting can be viewed on ASCO's website at www.university.asco.org/CT2010. ■

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