Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement

Abstract

The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions.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.

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Item Type:	Article
Authors/Creators:	This paper has 16 authors. You can scroll the list below to see them all or them all. Blagden, S.P. Billingham, L. Brown, L.C. Buckland, S.W. Cooper, A.M. Ellis, S. Fisher, W. Hughes, H. Keatley, D.A. Maignen, F.M. Morozov, A. Navaie, W. Pearson, S. Shaaban, A. Wydenbach, K. Kearns, P.R.
Copyright, Publisher and Additional Information:	© The Author(s) 2020. Published by Springer Nature on behalf of Cancer Research UK. Open Access: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Keywords:	Antineoplastic Agents; Clinical Trials as Topic; Humans; Neoplasms; Research Design
Dates:	Accepted: 6 November 2019 Published (online): 6 January 2020 Published: 18 February 2020
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Human Metabolism (Sheffield) The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Oncology (Sheffield)
Depositing User:	Symplectic Sheffield
Date Deposited:	14 Jan 2021 10:18
Last Modified:	14 Jan 2021 10:18
Status:	Published
Publisher:	Springer Science and Business Media LLC
Refereed:	Yes
Identification Number:	10.1038/s41416-019-0653-9
Related URLs:	PubMed URL
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:169987

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Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement

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