Abstract P5-10-02: Clinical trials: "A holistic approach"
Authors: Spears PA , Devine P , Finestone S , Carbine N 
Published: May 2016

Goal:

New and improved treatments depend on the completion of successful clinical trials. Our goal is to impact all aspects of the clinical trial process to enhance accrual and outcomes.

1) To provide patient focused feedback at the design phase of clinical trials

2) To increase health literacy about clinical trials at both the national and community level

3) To provide decision aids for individual trials

4) To provide patient focused staff communication trainings

Strategy: CISN principals are currently working with the following groups

National Clinical Trial Network

Academic Medical Centers: UCSF and Mayo

Industry: Genentech, Pfizer, Novartis, and Lilly

Nonprofit Organizations: AACR, Faster Cures, Susan G. Komen, SOCRA

CISN principals are working within the NCTN to accomplish strategies one and two. The goal is to branch out to more community venues in the future. A 2001 study by Lara et. al. reported that the consent process with its legalistic and confusing forms is itself a barrier to patient participation with 49% of eligible patients declining enrollment. We address these concerns by accomplishing strategies 3 and 4 above.

Action Taken

CISN is introducing the medical community to an array of issues affecting patients considering participation in clinical trials. They are also developing patient-centered, study specific, educational materials included as part of the informed consent process. These interventions may enhance patient literacy, improve patient satisfaction and advance public trust in the research enterprise, leading to responsible increased accrual and retention. Additionally, CISN has worked as a contractor for several biotech companies to develop patient educational materials for several studies.

Work done at the Clinical Trial Summit documented that 67% of professionals consenting patients have less than 6 hours of psychosocial training. To address that issue, CISN developed a training program for those professionals who administer consent. Two PhD psychologists where brought onboard as consultants to assist in the development of the training. To date CISN has conducted many trainings for various groups and will soon submit grants to partner with other organizations to translate the materials into Spanish and work with patient navigators to further ensure proper training in all communities.

Outcome

Interest in our methods and materials continues to grow. CISN was identified by Faster Cures as having "best practice" methods in the area of informed consent. We work closely with academic, government, other non-profits and industry researchers to help foster public awareness about the importance of medical research to daily life. CISN addresses these issues and presents various strategies that might be applied to NCI network group and industry trials so as to bridge the research gap, move research forward, and adopt the best course to serve the needs of the community, researchers and patients.

Citation Format: Spears PA, Devine P, Finestone S, Carbine N. Clinical trials: "A holistic approach". [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-10-02.