Transforming the Early Drug Development Paradigm at the National Cancer Institute: The Formation of NCI's Experimental Therapeutics Clinical Trials Network (ETCTN)
08/2019
Journal Article
Authors:
Massett, H. A.;
Mishkin, G.;
Moscow, J. A.;
Gravell, A. ;
Steketee, M.;
Kruhm, M.;
Han, S. H.;
Barry, B.;
Montello, M.;
Zwiebel, J.;
Abrams, J. S.;
Doroshow, J. H.;
Ivy, S. P.
Volume:
25
Pagination:
6925-6931
Issue:
23
Journal:
Clin Cancer Res
PMID:
31439585
URL:
https://www.ncbi.nlm.nih.gov/pubmed/31439585
DOI:
10.1158/1078-0432.CCR-19-1754
Keywords:
Antineoplastic Agents/*therapeutic use *Clinical Trials as Topic *Drug Development Financing, Organized Humans National Cancer Institute (U.S.) Neoplasms/diagnosis/*drug therapy/*economics Program Development
Research Personnel/*statistics & numerical data Research Support as Topic/*economics United States
Abstract:
Early drug development for cancer requires broad collaboration and skilled clinical investigators to enable enrollment of patients whose tumors have defined molecular profiles. To respond to these challenges, the National Cancer Institute (NCI) transformed its 60-year-old early-phase drug development program in 2014 into the Experimental Therapeutics Clinical Trials Network (ETCTN). The ETCTN is a consolidated, national network of 40+ academic institutions responsible for conducting more than 100 early-phase clinical trials. It promotes team science coordinated among basic, translational, and clinical investigators, emphasizing the inclusion of early career trialists. This perspective provides a brief overview of the ETCTN, summarizes its successes and challenges over its first grant funding cycle, and discusses the program's future directions. Measures indicated strong connectivity across the institutions, significant increases in investigator approval of the ETCTN scientific portfolio from years 1 to 4, and substantial research activity over 5 years, with 334 letters of intent submitted, 102 trials activated, and 3,570 patients accrued. The ETCTN's successful adoption relied heavily on the inclusion of senior investigators who have long-standing interactions with the NCI and a willingness to participate in a team science approach and to mentor early career investigators. In addition, NCI invested substantial resources in a centralized infrastructure to conduct trials and to support the inclusion of biomarkers in its studies. The ETCTN provides evidence that a collaborative national clinical trial network for early drug development is feasible and can address the demands of precision medicine approaches to oncologic clinical trials.
