Enabling clinicians and researchers to effectively conduct Complex Innovative Design cancer trials

A new report, published in the British Journal of Cancer, outlines recommendations for the effective delivery of Complex Innovative Design (CID) trials in the UK and Europe for the first time.

CID trials are those that address multiple clinical questions, assessing not just the safety and toxicity of novel anti-cancer medicines, but also established drugs used in a different cancer population. CID trials test efficacy in, for example, biomarker-selected patients, specific cancer cohorts or in combination treatments with other agents. 

The traditional cancer drug development pathway is increasingly being superseded by these kinds of trials, yet there have been no practical guidelines for conducting them in the UK and Europe despite the fact they can be challenging to design, conduct and interpret. 

To address this, the Experimental Cancer Medicine Centre (ECMC) network formed a working group with stakeholders from clinical trial units, the pharmaceutical industry, funding bodies, regulators and patients to identify the main challenges of CID trials. 

Together, we have produced 10 consensus recommendations. These aim to improve the conduct, quality and acceptability of oncology CID trials in clinical research and, importantly, to accelerate the process by which effective treatments can reach cancer patients.

Dr Aoife Regan, Head of the ECMC Programme Office, said, “This work is a great demonstration of the convening power of the ECMC Network, and is a key part in our work to ensure that the UK remains at the forefront of experimental cancer medicine. We also hope that these recommendations have relevance for complex trials in all disease types.”