Strategies to overcome barriers to accrual (BtA) to NCI-sponsored clinical trials: A project of the NCI-Myeloma Steering Committee Accrual Working Group (NCI-MYSC AWG).

Lymphoma and Plasma Cell Disorders
Session Type and Session Title: 
General Poster Session, Lymphoma and Plasma Cell Disorders
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr 8592)
Matthias Weiss, Morie A. Gertz, Richard F. Little, Vincent Rajkumar, Susanna J. Jacobus, Rafat Abonour, Kenneth Carl Anderson, Bart Barlogie, Natalie Scott Callander, Edward J. Gorak, Jeffrey Matous, Glenn Morris Mills, Robert C. Kane, Michael S. Katz, LeeAnn Jensen, James Omel, Robert Z. Orlowski, Paul Gerard Guy Richardson, Nikhil C. Munshi; Marshfield Clinic, Marshfield, WI; Mayo Clinic, Rochester, MN; National Cancer Institute, Rockville, MD; Dana-Farber Cancer Institute, Boston, MA; Indiana University Simon Cancer Center, Indianapolis, IN; Myeloma Institute for Research and Therapy, Little Rock, AR; University of Wisconsin, Madison, WI; Geisinger Medical Center, Danville, PA; Rocky Mountain Cancer Centers, Denver, CO; LSU Health Sciences Center, Shreveport, LA; Food and Drug Administration, Silver Spring, MD; International Myeloma Foundation, North Hollywood, CA; National Cancer Institue, Rockville, MD; Patient Advocate, Rockville, MD; The University of Texas MD Anderson Cancer Center, Houston, TX; VA Boston Healthcare System; Dana-Farber Cancer Institute, Boston, MA

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Abstract Disclosures


Background: Accrual to NCI clinical trials(CT)is often slower than planned at times mandating premature closure resulting in loss of valuable resources and delay of scientific progress. Methods: The NCI-MYSC AWG identified 10 potential BtA. SWOG, ECOG and Alliance investigators were queried and agreed that these barriers impede accrual (results stratified for academic and community sites). The MYSC AWG developed in collaboration with NCI and FDA strategies to overcome these barriers. Results: Strategies listed for the 3 most often cited BtA: 1. Reimbursement for CT related expenses:increase awareness of improved reimbursement for phase II CT; tailor reimbursement according to CT complexity; request funds from industry and other sources (http://biqsfp.cancer.gov) for qualifying ancillary CT components. 2. Spectrum of available treatment options influences CT participation: educate patients and providers about the significance of a new CT using social media, presentations at national meetings and by adding educational material to CT protocol; encourage opinion leaders and advocacy groups not to promote a new therapy as “standard” in the absence of phase III data. 3. Requirement of CT specific therapy at NCI designated sites only: “MYSC AWG Drug Administration Table” describes NCI/FDA approved rules for CT specific drug administration; CT protocol will outline which standard treatment components of a CT can be administered at any site as long as protocol specific guidelines are followed and conduct is supervised by enrolling investigator. Examples of additional strategies to overcome identified BtA: determine feasibility, indication and insurance coverage of CT specific tests during protocol development; discourage narrow eligibility criteria; avoid competing CT; allow up to 1 cycle of commercially available therapy prior to enrollment; CIRB support for phase II CT. Conclusions: The MYSC Accrual Working Group developed in collaboration with NCI and FDA strategies to overcome barriers to myeloma clinical trial accrual. These strategies may be applicable to NCI-sponsored clinical trials evaluating interventions in other diseases.