Practicalities in running early-phase trials using the time-to-event continual reassessment method (TiTE-CRM) for interventions with long toxicity periods using two radiotherapy oncology trials as examples.
Erik van WerkhovenSamantha HinsleyEleni FrangouJane HolmesRosemarie de HaanMaria HawkinsSarah BrownSharon B LovePublished in: BMC medical research methodology (2020)
Model-based designs can be complex. We hope this paper will help clinical trial teams to demystify the conduct of TiTE-CRM trials and be a starting point for using this methodology in practice.