Whitepaper: What the New FDA Guidelines Mean for Patient-Reported Outcomes in Oncology Trials

The FDA has just released its draft guidance on oncology clinical trials using patient reported outcome measures (PROMS). The guidance covers such topics as study design, instrumentation, implementation, and more. A new Signant Health white paper breaks down what these guidelines mean for the field, explains how it changes the current oncology trial landscape, and offers recommendations on trial design.

According to the white paper, “Typically, in oncology trials patients are asked to complete PROMs at clinic visits at the start of each cycle of treatment. This is the point at which patients have recovered sufficiently from the previous treatment to receive the next cycle. If patients are not well enough to commence treatment, then cycle starts and the associated PROM assessments are delayed. This  assessment schedule is, therefore, less optimal for PROMs assessing the impact of treatment.”

Download the free white paper by clicking here.

(Source: Signant Health, February 14^th, 2022)