The rapid enrollment design for Phase I clinical trials

We propose a dose‐finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose–toxicity curve is non‐decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow‐up. We also recommend always using a safety rule in any fast accruing dose‐finding trial. Copyright © 2016 John Wiley & Sons, Ltd.