Recommendations for clinical trial accrual published in Journal of Oncology Practice

October 21, 2013

CLEVELAND: New recommendations for overcoming issues related to cancer clinical trial accrual have been published online in the Journal of Oncology Practice. Following a National Cancer Institute (NCI) and American Society of Clinical Oncology (ASCO) co-sponsored symposium, the research team compiled a summary of best practices and strategies for future research aimed at advancing cancer trials more rapidly.

"Cancer clinical trials provide the evidence base for new advances in oncology. However, only a few percent of cancer patients participate in them," says Neal J. Meropol, MD, senior author, Chief of the Division of Hematology and Oncology at UH Case Medical Center and Case Western Reserve University School of Medicine. "Poor enrollment onto trials threatens to slow progress in cancer care at a time when advances in science are enabling new opportunities for prevention and treatment. To help address this problem, we have compiled a series of recommendations to address multiple barriers to clinical trials for patients, health care providers and the clinical trials sites."

Titled "Cancer Trial Accrual Symposium: Science and Solutions", the symposium brought together more than 350 cancer research experts, including clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. It was held in Bethesda, MD, in April 2010.

Common barriers to patient enrollment in clinical trials include lack of awareness, fear of side effects, receiving placebo instead of treatment, financial concerns and logistical issues.

For health care providers, a common obstacle is the view that clinical trials should only be considered as a "last resort" option. Attendees developed innovative strategies for improving recruitment and identified priority areas for future research at the patient/community, physician/provider, and site/organizational levels.

Recommendations at the patient/community level included involving patient advocates, community leaders, representatives of target minority groups, peer mentors and patient navigators to enhance recruitment and retention. Simplifying patient consent forms and enhancing communication during the informed consent process as well as including multilingual staff and medical interpreters on the medical team were additional strategies.

In the physican/provider arena, recommendations included developing evidence-based training initiatives to improve communication and disseminating the availability of local trials to primary care providers. Using information technology such as registries and electronic health records was also encouraged.

At the site level, participants suggested promoting accrual through leadership best practices, including establishing a "culture of commitment" to clinical trials in addition to adopting formal quality improvement processes to increase the efficiency of opening and conducting trials.

"Clinical trials should be considered as an option in the care for all patients with cancer, regardless of their socioeconomic status or where they choose to receive their care," concluded the authors. "If all sites participating in cancer clinical trials identify ways in which to improve their own accrual, we will be able to advance cancer research more rapidly and ultimately improve the lives of people at risk for or diagnosed with cancer."
The study's coauthors are: Andrea M. Denicoff, MS, RN; Worta McCaskill-Stevens, MD, MS, Stephen S. Grubbs, MD; Suanna S. Bruinooge, Robert L. Comis, MD, Peggy Devine, David M. Dilts, PhD, MBA, CMA; Michelle E. Duff, DPT, Jean G. Ford, MD, Steven Joffe, MD, MPH, Lidia Schapira, MD; Kevin P. Weinfurt, PhD; Margo Michaels, MPH; Derek Raghavan, MD, PhD; Ellen S. Richmond, MS, RN; Robin Zon, MD, FACP, FASCO; Terrance L. Albrecht, PhD; Michael A. Bookman, MD; Afshin Dowlati, MD; Rebecca Enos, RN, MPH; Mona N. Fouad, MD, MPH; Marjorie Good, RN, MPH, OCN; William J. Hicks, MD; Patrick J. Loehrer Sr, MD; Alan P. Lyss, MD; Steven N. Wolff, MD; and Debra M. Wujcik, PhD, RN, FAAN.

University Hospitals Case Medical Center

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