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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2020, The Author(s). The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions. These are collectively termed Complex Innovative Design (CID) trials. CID trials not only assess the safety and toxicity of novel anticancer medicines but also their efficacy in biomarker-selected patients, specific cancer cohorts or in combination with other agents. They can be adapted to include new cohorts and test additional agents within a single protocol. Whilst CID trials can speed up the traditional route to drug licencing, they can be challenging to design, conduct and interpret. The Experimental Cancer Medicine Centres (ECMC) network, funded by the National Institute for Health Research (NIHR), Cancer Research UK (CRUK) and the Health Boards of Wales, Northern Ireland and Scotland, formed a working group with relevant stakeholders from clinical trials units, the pharmaceutical industry, funding bodies, regulators and patients to identify the main challenges of CID trials. The working group generated ten consensus recommendations. These aim to improve the conduct, quality and acceptability of oncology CID trials in clinical research and, importantly, to expedite the process by which effective treatments can reach cancer patients.
Author(s): Blagden SP, Billingham L, Brown LC, Buckland SW, Cooper AM, Ellis S, Fisher W, Hughes H, Keatley DA, Maignen FM, Morozov A, Navaie W, Pearson S, Shaaban A, Wydenbach K, Kearns PR, Abouzeid C, Ahmed R, Bailey S, Blewett C, Campbell H, Cerone MA, Clack G, Cook N, Ghiorghiu S, Halford S, Johnston A, Kaplan R, Lawson A, Lowe E, Mathews J, Mirabile I, Osipenko L, Patel D, Potter C, Regan A, Ricamara M, Ringrose C, Rodger J, Sandhu GK, Schiavone F, Silvester J, Sydes MR, Weller C, Yiangou A
Publication type: Article
Publication status: Published
Journal: British Journal of Cancer
Year: 2020
Volume: 122
Pages: 473-482
Print publication date: 18/02/2020
Online publication date: 06/01/2020
Acceptance date: 06/11/2019
Date deposited: 20/01/2020
ISSN (print): 0007-0920
ISSN (electronic): 1532-1827
Publisher: Springer Nature
URL: https://doi.org/10.1038/s41416-019-0653-9
DOI: 10.1038/s41416-019-0653-9
PubMed id: 31907370
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