Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement
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.
The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions.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 anti-cancer medicines but their efficacy in, for example, biomarker-selected patients, specific cancer cohorts or in combination with other agents. They can be adapted to include new cohorts, for example to test additional agents, during the trial. Whilst CID trials can speed up the traditional route to drug licencing, they can be challenging to design, conduct and interpret. To address this, the Experimental Cancer Medicine Centre (ECMC) network 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.