TY - JOUR
T1 - Accelerating the Future of Oncology Drug Development
T2 - The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials
AU - Liu, Jia
AU - Farrow, Max
AU - Seymour, Lesley
AU - Desai, Jayesh
AU - Loong, Herbert H.
AU - Ivy, Percy
AU - Koyoma, Takafumi
AU - Cook, Natalie
AU - Blagden, Sarah
AU - Garralda, Elena
AU - Massard, Christophe
AU - Tolcher, Anthony W.
AU - Adashek, Jacob J.
AU - Zhang, Li
AU - Zhao, Shen
AU - Shen, Lin
AU - Kurzrock, Razelle
AU - El-Deiry, Wafik S.
AU - Subbiah, Vivek
AU - Joshua, Anthony M.
N1 - Publisher Copyright:
© 2025 American Society of Clinical Oncology.
PY - 2025/1/1
Y1 - 2025/1/1
N2 - PURPOSEOver the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner. Networks and consortia may overcome some of these challenges of enrolling suitable patients and streamlining start-up, particularly when distance and disease trajectory come into play.DESIGNIn this article, we provide an overview of EPCT consortia in adult oncology across different continents assembled through systematic review of the literature and snowball sampling methodology. We illustrate their scope, structure, funding, and achievements.RESULTSFifteen EPCT consortia were identified including two in the United States, three in Europe, five in Asia-Pacific, two intercontinental consortia, and three within private oncology networks. These consortia vary in their scope, funding, and structure from government-funded models such as the National Cancer Institute Experimental Therapeutics Clinical Trials Networks through charitably funded and private research organizations. EPCT consortia play a role in collaborative research, molecular tumor boards to provide patient-centric biomarker-matched treatments, and streamlining trial conduct to improve timelines and cost efficiency.CONCLUSIONThe growth in EPCT activity and complexity has resulted in expansion in the number of EPCT consortia globally. By actively engaging with regulatory bodies and pharmaceutical and contract research organization industries, consortia have an opportunity to address the evolving challenges faced in this field and to accelerate the translation of scientific discoveries into clinical practice.
AB - PURPOSEOver the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner. Networks and consortia may overcome some of these challenges of enrolling suitable patients and streamlining start-up, particularly when distance and disease trajectory come into play.DESIGNIn this article, we provide an overview of EPCT consortia in adult oncology across different continents assembled through systematic review of the literature and snowball sampling methodology. We illustrate their scope, structure, funding, and achievements.RESULTSFifteen EPCT consortia were identified including two in the United States, three in Europe, five in Asia-Pacific, two intercontinental consortia, and three within private oncology networks. These consortia vary in their scope, funding, and structure from government-funded models such as the National Cancer Institute Experimental Therapeutics Clinical Trials Networks through charitably funded and private research organizations. EPCT consortia play a role in collaborative research, molecular tumor boards to provide patient-centric biomarker-matched treatments, and streamlining trial conduct to improve timelines and cost efficiency.CONCLUSIONThe growth in EPCT activity and complexity has resulted in expansion in the number of EPCT consortia globally. By actively engaging with regulatory bodies and pharmaceutical and contract research organization industries, consortia have an opportunity to address the evolving challenges faced in this field and to accelerate the translation of scientific discoveries into clinical practice.
UR - http://www.scopus.com/inward/record.url?scp=85215858972&partnerID=8YFLogxK
U2 - 10.1200/JCO-24-01534
DO - 10.1200/JCO-24-01534
M3 - Review article
C2 - 39808749
AN - SCOPUS:85215858972
SN - 0732-183X
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
ER -