TY - JOUR
T1 - Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement
AU - Experimental Cancer Medicine Centres (ECMC) CID trials working group
AU - Blagden, Sarah P.
AU - Billingham, Lucinda
AU - Brown, Louise C.
AU - Buckland, Sean W.
AU - Cooper, Alison M.
AU - Ellis, Stephanie
AU - Fisher, Wendy
AU - Hughes, Helen
AU - Keatley, Debbie A.
AU - Maignen, Francois M.
AU - Morozov, Alex
AU - Navaie, Will
AU - Pearson, Sarah
AU - Shaaban, Abeer
AU - Wydenbach, Kirsty
AU - Kearns, Pamela R.
PY - 2020/1/6
Y1 - 2020/1/6
N2 - The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions.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.
AB - The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions.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.
UR - http://www.scopus.com/inward/record.url?scp=85077526040&partnerID=8YFLogxK
U2 - 10.1038/s41416-019-0653-9
DO - 10.1038/s41416-019-0653-9
M3 - Article
SN - 0007-0920
VL - 122
SP - 473
EP - 482
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 4
ER -
