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

Author:

Blagden Sarah P., ,Billingham Lucinda,Brown Louise C.,Buckland Sean W.,Cooper Alison M.,Ellis Stephanie,Fisher Wendy,Hughes Helen,Keatley Debbie A.,Maignen Francois M.,Morozov Alex,Navaie Will,Pearson Sarah,Shaaban Abeer,Wydenbach Kirsty,Kearns Pamela R.

Abstract

AbstractThe traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions.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

Funder

Cancer Research UK

Publisher

Springer Science and Business Media LLC

Subject

Cancer Research,Oncology

Reference33 articles.

1. International Agency for Research on Cancer. All cancers fact sheet. Globocan, 2018. http://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf (2018).

2. International Agency for Research on Cancer. Cancer tomorrow—Estimated number of incident cases from 2018 to 2040, all cancers, both sexes, all ages. https://gco.iarc.fr/tomorrow/graphic-isotype?type=0&;population=900&mode=population&sex=0&cancer=39&age_group=value&apc_male=0&apc_female=0 (2018).

3. The Institute of Cancer Research. From Patent to Patient—Analysing access to innovative cancer drugs. https://d1ijoxngr27nfi.cloudfront.net/docs/default-source/default-document-library/from-patent-to-patient.pdf?sfvrsn=8fa95f69_2 (2018).

4. Bhatt, D. L. & Mehta C. Adaptive designs for clinical trials. https://doi.org/10.1056/NEJMra1510061. https://www.nejm.org/doi/10.1056/NEJMra1510061 (2016).

5. Renfro, L. A. & Mandrekar, S. J. Definitions and statistical properties of master protocols for personalized medicine in oncology. J. Biopharm. Stat. 28, 217–228 (2018).

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3