Abstract
Background
The Ohio State University Comprehensive Cancer Center (OSUCCC) embarked on a single institution campaign over 2 years to enhance the enrollment of cancer patients into therapeutic clinical trials. The goal of this campaign was to achieve a 40 % increase in accrual over a 2-year period.
Methods
The entire process of accruing patients to clinical trials at the OSUCCC was carefully evaluated and broken down into several interlocking components. The four key areas of emphasis were as follows: (i) tasking of OSUCCC leadership with increased oversight of the entire process; (ii) education of all stakeholders [patients, their families, nurses and staff, physicians (both internal and external), Disease-Specific Committees (DSCs), and the OSUCCC leadership] as to the purpose, advantages, and availability of clinical trials, with an emphasis on accrual to cancer clinical trials (CCTs) being a critical function of all OSUCCC employees; (iii) increased oversight of the portfolio of clinical trials by DSCs; and (iv) optimization of accrual operations and infrastructure center-wide.
Results
The accrual goal was achieved a full 4 months ahead of schedule. In total, 2327 patients were accrued to therapeutic clinical trials over the course of this 2-year campaign. Prior to implementation of the accrual program, the accrual rate was consistently below 15 %. From 2009 onwards, the therapeutic accrual rate was always greater than 25 %.
Conclusions
A campaign to educate key stakeholders in the clinical trials accrual process was successful in its goal of increasing accrual to therapeutic trials.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21(5):830–5.
Lara PN Jr., Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728–33.
Go RS, Frisby KA, Lee JA, et al. Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer. 2006;106(2):426–33.
Sherman SL, Waldinger MB, Lepisto EM, Hinkel JM, Minogue KA, Paul DE. The 2008 National Comprehensive Cancer Network (NCCN) research benchmarking survey (RBS): clinical trials (CTs) operations in the academic center. J Clin Oncol. 2010;28(15 Suppl): 6154.
Djulbegovic B, Kumar A, Soares HP, et al. Treatment success in cancer: new cancer treatment successes identified in phase 3 randomized controlled trials conducted by the national cancer institute-sponsored cooperative oncology groups, 1955 to 2006. Arch Intern Med. 2008;168(6):632–42.
Horstmann E, Yamamoto S, Budd T, et al. Risk and benefits of phase 1-oncology trials, 1991 through 2002. N Engl J Med. 2005;352(9):895–904.
Du W, Mood D, Gadgeel S, et al. An educational video to increase clinical trials enrollment among breast cancer patients. Breast Cancer Res Treat. 2009;117(2):339–47.
Umutyan A, Chiechi C, Beckett LA, et al. Overcoming barriers to cancer clinical trial accrual: impact of a mass media campaign. Cancer. 2008;112(1):212–9.
Day T, Tosey P. Beyond SMART? A new framework for goal setting. Curriculum J. 2011;22(4):515–34.
Cheng SK, Dietrich MS, Dilts DM. A sense of urgency: evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies. Clin Cancer Res. 2010;16(22):5557–63.
Heskett JL, Jones TO, Loveman GW, Sasser WE Jr., Schlesinger LA. Putting the service-profit chain to work. Harv Bus Rev. 2008;86(7–8):164–70.
Balch CM, Nelson H, Niederhuber J. Surgery: limitations of prospective surgical oncology—a US view. Nat Rev Clin Oncol. 2016;13(1):6–8.
London JW, Balestrucci L, Chatterjee D, Zhan T. Design-phase prediction of potential cancer clinical trial accrual success using a research data mart. J Am Med Inform Assoc. 2013;20(e2):e260–6.
Lewis JH, Kilgore ML, Goldman DP, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383–9.
Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720–6.
Sateren WB, Trimble EL, Abrams J, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002;20(8):2109–17.
Ghebre RG, Jones LA, Wenzel JA, Martin MY, Durant RW, Ford JG. State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. Cancer. 2014;120:1122–30.
Conflict of interest
Mark Porter, Bhuvaneswari Ramaswamy, Karen Beisler, Poonam Neki, Nancy Single, James Thomas, Janie Hofacker, Michael Caligiuri, and William E. Carson III report no conflicts of interest.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Porter, M., Ramaswamy, B., Beisler, K. et al. A Comprehensive Program for the Enhancement of Accrual to Clinical Trials. Ann Surg Oncol 23, 2146–2152 (2016). https://doi.org/10.1245/s10434-016-5091-9
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1245/s10434-016-5091-9