Working with UK Regulators
The ECMC Programme Office has worked with key stakeholders to address some of the challenges associated with set up and conducting research in a system as complex as the NHS.
Delivery of Complex Innovative Design Cancer Trials
The traditional cancer drug development pathway has increasingly been superseded by trials that address multiple clinical questions.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 in combination with other agents. They can be adapted to include new cohorts and test additional agents within a single protocol. The ECMC Programme Office 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 clinical trials. The working group generated ten consensus recommendations.
Following on from the recommendations the ECMC PO and the Health Research Authority collaborated to produce a set of podcasts to inform and educate a range of stakeholders around the management and delivery of CID trials.
New regulatory routes for cancer treatment in Britain
The departure of the UK from the EU in 2020 resulted in the Medicines and Healthcare products Regulatory Agency (MHRA) becoming a standalone regulator. This independence provided an opportunity to review the drug development and access pathway. The ECMC PO brought together a multi-stakeholder working group to compile a summary of the current status of the new regulatory approvals process