Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement
Sarah P. Blagden, Lucinda Billingham, Louise Brown, Sean Buckland, Alison M. Cooper, Stephanie Ellis, Wendy Fisher, H Hughes, Debbie Keatley, F. Maignen, Alex Morozov, Will Navaie, Sarah Pearson, Abeer M. Shaaban, Kirsty Wydenbach, Pamela Kearns, Christiane Abouzeid, Rubina Ahmed, Sue Bailey, Catherine Blewett, Helen Campbell, Maria Antonietta Cerone, Glen Clack, Natalie Cook, Serban Ghiorghiu, Sarah Halford, Andrew Johnston, Rick Kaplan, Anna Lawson, Emma T. Lowe, Jacqueline Mathews, Ilaria Mirabile, Leeza Osipenko, Dipak Patel, Claire Potter, Aoife Regan, Marivic Ricamara, Carly Ringrose, Joanne Rodger, Gurcharan K. Sandhu, Francesca Schiavone, Julie Silvester, Matthew R. Sydes, Charles G. Weller, A. Yiangou
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The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions.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.