@article{c8f945e607f544e1a2a94623771ea056,
title = "Clinical trial enrollment of adolescents and young adults with sarcoma",
abstract = "More than half of all sarcomas occur in adolescents and young adults (AYAs) aged 15 to 39 years. After the publication of the AYA series in the April 1, 2016 issue of Cancer, several leaders in the field of sarcoma across disciplines gathered to discuss the status of sarcoma clinical research in AYAs. They determined that a focused effort to include the underrepresented and understudied AYA population in current and future sarcoma clinical trials is overdue. Trial enrichment for AYA-aged sarcoma patients will produce more meaningful results that better represent the disease's biology, epidemiology, and treatment environment. To address the current deficit, this commentary outlines changes believed to be necessary to expediently achieve an increase in the enrollment of AYAs in sarcoma clinical trials. Cancer 2017;123:3434-40.",
keywords = "National Clinical Trials Network, adolescent, clinical trials, sarcoma, young adult",
author = "Davis, {Lara E.} and Janeway, {Katherine A.} and Weiss, {Aaron R.} and Chen, {Yen Lin E.} and Scharschmidt, {Thomas J.} and Mark Krailo and {Glade Bender}, {Julia L.} and Kopp, {Lisa M.} and Patel, {Shreyaskumar R.} and Schwartz, {Gary K.} and Horvath, {L. Elise} and Hawkins, {Douglas S.} and Chuk, {Meredith K.} and Reinke, {Denise K.} and Gorlick, {Richard G.} and Randall, {R. Lor}",
note = "Funding Information: Lara E. Davis reports grants from Novartis, personal fees from Eisai, and personal fees from Foundation Medicine outside the submitted work. Yen-Lin E. Chen reports grants and nonfinancial support (clinical trial support) from the Children{\textquoteright}s Oncology Group and NRG Oncology during the conduct of this study. Mark Krailo reports personal fees from Merck outside the submitted work. Shreyaskumar R. Patel reports grants and personal fees from Jans-sen, grants and personal fees from Eisai, grants from Morphotek, personal fees from EMD Serono, personal fees from CytRx, personal fees from Bayer, and personal fees from Eli Lilly outside the submitted work. R. Lor Randall reports working as a consultant for Zimmer Biomet. Funding Information: SARC is a nonprofit consortium of academic researchers that is funded in part through an NCI Specialized Program of Research Excellence (SPORE) grant. A goal of SARC{\textquoteright}s founding leaders, who included pediatric and medical oncologists, was to develop clinical trials including the full age spectrum for the disease being studied. When there is an exciting new therapeutic approach and both disciplines are included in the development of the study, rapid accrual across the population has been achieved (Table 1). Despite this commitment and the ability to activate studies including a lower age limit of 4 years, the enrollment of patients under the age of 18 years has not consistently been robust. From the perspective of SARC, the obstacles that hamper achieving enrollment of the full spectrum of the sarcoma population include the following: • There is separation of programs within academic insti-tutions. Contracting, IRB, and investigational drug services are separate for adult and pediatric depart-ments, and this results in increased costs and complex-ity; often, data management teams are separate as well. • There is a lack of complete engagement and commit-ment between the 2 disciplines in the design and devel-opment of study protocols. • SARC is not an NCI NCTN grantee and is, therefore, ineligible to be an LPO or to participate in CTSU cross-enrollment. Publisher Copyright: {\textcopyright} 2017 American Cancer Society",
year = "2017",
month = sep,
day = "15",
doi = "10.1002/cncr.30757",
language = "English (US)",
volume = "123",
pages = "3434--3440",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "18",
}