Time for a Clinical Trials Revolution – Complex Innovative Design (CID) Cancer Trials
This 1-hour webinar reviews a published consensus statement from the British Journal of Cancer (BJC), looking at recommendations for effective delivery of Complex Innovative Design (CID) cancer trials.
The traditional cancer drug development pathway is being superseded by trials that address multiple clinical questions. 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.
Sarah Blagden, Associate Professor of Medical Oncology, University of Oxford and Alain Thibault, Chairman Simbec-Orion Oncology Advisory Board, will review the changing landscape and the need for a clinical trials revolution in early phase oncology drug development. They will also review the operational recommendations and practical considerations for delivering CID cancer trials.
This webinar covers:
- The changing landscape of oncology drug development – safety, toxicity and efficacy in biomarker selected patient cohorts and other agents
- Trial planning & design – stakeholder engagement, engagement with regulators
- Protocol development & structure – identifying adaptations
- Data & databases – defining the end of the trial
- Risk assessment & monitoring – financial and operational, including source data verification
- Trial management – the importance of compliance and communication in managing multiple cohorts from multiple parties
- Statistical considerations – experience and flexibility