Lyerly HK, Ren J, Canetta R, Kim GH, Nagai S, Yamaguchi T, Hatogai K, Katayama H, Da Rocha Dias S, McManus D, Soltys K, Yang Z, Olopade O, Goodman N, Reaman G, Gross T.
J Glob Oncol. 2018 Dec;4:1-11. doi: 10.1200/JGO.18.00092. PMID: 30521412; PMCID: PMC7010455.
Based on the presentations of the international workshop in 2017 in North Bethesda, MD, the article discusses the individual regulatory pathways for marketing approval and reimbursement for individual nations conducting global cancer trials with a focus on uncommon cancers. A lack of uniform standards in both regulatory approval for marketing and reimbursement for approved agents across countries may make the newly developed agent either unavailable or inaccessible to patients in certain countries or regions, even if patients from those countries or regions participated in the clinical research.