While oncology trials comprise a large proportion of current research pipelines, conventional oncology development programs are frequently expensive, inefficient, and plagued by high failure rates. In the early stage of a trial, decisions about dose selection and target indications are of paramount importance and incorporating innovative design strategies such as adaptive designs and master protocols lead to more efficient, cost-effective trials. This webinar contrasts the Continual Reassessment Method (CRM) with other dose escalation designs and demonstrates the advantages of basket trial designs for dose expansion studies. Click here to register.
- Improved determination of the maximum tolerated dose, comparing different designs for dose selection
- Advantages of basket trial design for finding the most appropriate indication(s)
- Current regulatory positions and outlook of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human use (ICH)
- Operational implications of different designs
Jurgen Hummel, Senior Director of Statistical Science, Biostatistics, PPD
Dirk Reitsma, MD, Vice President and Therapeutic Area Head, Oncology, Global Product Development, Evidera