General Discussions

Clinical Trial Enrollment

By Lisa Schulmeister, RN, MN, APRN-BC, OCN, FAAN
It is well recognized that increasing the number of patients enrolled in clinical trials could potentially improve cancer care and patient outcomes. However, the many challenges to accruing patients in these trials have created barriers to enrollment. The National Cancer Institute (NCI) and American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions to identity strategies to increase clinical trial enrollment. The symposium consisted of presentations, breakout sessions, and posters and the 358 attendees represented stakeholders ranging from patient advocates to research coordinators.  

Common barriers to patient enrollment in clinical trials include lack of awareness, fear of side effects, receiving a placebo instead of treatment (which was viewed as receiving no treatment versus receiving treatment), financial concerns, and logistical issues that included transportation concerns and increased frequency of testing.

The group concluded that a combination of approaches is needed to address the multifactorial nature of accrual challenges. For healthcare providers, to overcome the barrier of viewing clinical trials as a last resort option, the group suggested peer mentors and use of patient navigators in recruitment and retention. They also suggested simplifying consent forms and improving communication during the informed decision making process. Crucial to improved communication is the ability to present needed information in the patient’s preferred language; consequently, the group envisioned the benefit of having multilingual staff and medical interpreters.

Additional recommendations included developing evidence-based training initiatives for healthcare providers to improve communication and disseminating the availability of local trials to primary care providers in the community. Using information technology such as registries and electronic health records also was encouraged. At the site level, the group suggested promoting accrual through leadership best practices, including establishing a culture of commitment to clinical trials and esstreamlining the process of opening and conducting clinical trials.

Denicoff AM, McCaskill-Stevens W, Grubbs SS, et al. The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations. Journal of Oncology Practice; published online before print October 15, 2013, doi: 10.1200/JOP.2013.001119.
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