Design, power, and alpha levels in randomized phase II oncology trials

Summary: This study examined the methodology, reporting, and bias in the interpretation of outcomes in randomized phase II oncology trials. It found that many trials failed to report essential data for determining sample size calculations, did not use a comparator to determine efficacy, and had positive conclusions even though the results were indeterminate or the primary endpoint was not met. The study concluded that phase II trials need to adhere to the same reporting standards and be interpreted in the context of their primary endpoint and endpoints important for the patient.

(By ChatGPT, reviewed and edited)

Article: Design, power, and alpha levels in randomized phase II oncology trials – ESMO Open