A group of UK experts have made recommendations on the use of Complex Innovative Design (CID) cancer trials.
Trials that address multiple clinical questions in the cancer drug development pathway are collectively termed CID trials. CID trials assess the safety and toxicity of novel anticancer medicines as well as their efficacy in biomarker-selected patients, specific cohorts or in combination with other treatments. Adaptations of these trials can include new cohorts and allow testing of additional agents within a single protocol. They can enhance the traditional route to drug licencing, however, they can be challenging to design, conduct and interpret.
The experts have proposed ten consensus recommendations which aim to improve the conduct, quality and acceptability of cancer CID trials in clinical research, allowing more effective treatments to reach cancer patients.
Here is a simplified list of the recommendations:
- Early stakeholder engagement in trial planning and design.
- Robust, but adaptable, protocol development.
- Patient and public involvement.
- Encouraging patient-facing multimedia documentation.
- Experienced and detailed statistical considerations.
- Defined leadership and management responsibilities for trial conduct and delivery.
- Dissemination of trial results.
- Evaluation of the impact on the trial team and training requirements.
- Fat-tracking CID trials to the clinic to allow rapid transition to regulatory approval.
- Evaluation of the public health impact of CID trials.
Oncology CID trials have the potential to facilitate rapid access to innovative treatments, to enhance the therapeutic options available to cancer patients and to accelerate the development of treatments that can significantly improve clinical outcomes. The above recommendations provide a framework for multiple stake-holders to ensure that the experience gained from conducting these trials is shared efficiently between regulatory authorities, optimising the approval of life-saving treatments.
To read more about the recommendations of the expert group, click here.