The OSUCCC– James designed a culture-changing program to raise clinical trial participation rates
BY WILLIAM E. CARSON III, MD, Associate Director for Clinical Research, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
In 2007, we at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) conducted a comprehensive review of patient participation in therapeutic clinical trials and discovered that our accrual rate had flatlined at about 14 percent per year.
While that rate was significantly higher than the 2-3 percent of adult cancer patients nationally who participate in treatment trials, we wanted to do far better. Clinical trials, after all, are the source of new treatments for our patients, giving them access to the most advanced therapies and the highest standards of care.
Every agent regarded as the standard of care today was first tested in a clinical trial at some point. High trial-participation rates are associated with many of our greatest achievements in cancer care. Cancers in which we’ve had the most success, such as childhood cancers and testicular cancer, have high rates of clinical trial participation.
The Ohio State University is an NCI-designated Comprehensive Cancer Center, and clinical trials are where our clinical mission and our research mission intersect, where advances in the laboratory are first applied to patient care. They are not something separate that we do; they are why we are here. We should regard all patients as potential trial participants, and we should provide all patients with an opportunity to participate.
To convey these messages to our physicians and staff, to referring physicians and to our patients and their families, we designed a multipronged campaign titled “2010 by 2010,” and launched it in late 2007. Our goal was to accrue 2,010 patients to therapeutic clinical trials by the year 2010, which would represent a 40-percent increase over 2007 accrual levels.
First, Michael A. Caligiuri, MD, director of the OSUCCC and CEO of The James, along with James Thomas, MD, director of our Clinical Trials Office, and I took the campaign to all hospital leaders, division chiefs and staff councils to explain our campaign strategy.
We used several mechanisms to educate patients and families about clinical trials. An updated clinical-trials brochure was placed in new-patient mail packets and made available in clinic waiting areas. Attractive posters with testimonials by clinical-trial participants were displayed near clinic areas, a clinical-trials video ran in a kiosk in The James lobby and in patient rooms, and hospital physicians and staff wore a colorful button that read, “Ask Your Doctor About Clinical Trials.”
We reached out to nursing staff by providing information about clinical trials during new-employee orientation, and OSUCCC leadership held a series of informal educational sessions with nursing units and physician groups. Nurses began encouraging patients to ask their doctors about clinical trials at The James.
We reinvigorated faculty by reminding them of the importance of clinical trials through presentations at faculty meetings, during orientation for new physicians, and in one-on-one meetings, and we dedicated a session of the OSUCCC Grand Rounds to the topic. We provided support to top accruers and trial coordinators, and we offered help with protocol development to those who needed it.
Referring physicians received targeted, disease-specific, monthly e-mail updates about our clinical trial activity, and new clinical trials were featured in OSUCCC – James publications.
We reorganized our Clinical Trials Office into disease teams and adopted a management system that enabled us to monitor accrual rates and conduct trials more efficiently. Trial development and implementation was organized along disease-specific lines. The hospital’s 10 disease-specific committees were charged with conducting a real-time analysis of accrual progress, regularly evaluating their clinical trials portfolio and examining their protocol activation timelines.
These changes enabled us to open trials faster and accrue patients more efficiently. OSUCCC members were updated on the progress of the campaign through monthly e-mail announcements that provided detailed accrual information.
At the state level, we wrote the Ohio Cancer Clinical Trial Legislation, which requires insurance companies to cover the routine costs of care associated with clinical trials such as physician visits, blood work, hospital stays and X-rays.
The campaign was highly successful. We achieved our goal of accruing 2,010 therapeutic patients in late August 2009, four months ahead of schedule. Furthermore, we surpassed our goal by 695 patients, or 35 percent.
Currently, 27 percent of patients coming to The James for therapy are entering clinical trials. Beyond that, we want to increase our rate to 40 percent and establish a program-wide mindset that regards every patient as a potential participant in a clinical trial.
Our experience shows that a comprehensive campaign to increase accrual to therapeutic trials by educating key stake holders in the clinical trials process can be successful. For more information on our program, please send an e-mail with your questions to email@example.com.