USA – FDA releases draft guidance on assessment of PROs for cancer trials

The US Food and Drug Administration (FDA) has released a draft guidance that recommends how sponsors can collect “meaningful” patient-reported outcome (PRO) measurements to assess results from cancer clinical trials.
 
The draft guidance focuses on PRO measures that are intended to demonstrate a drug’s effect on survival, tumor response, or the progression of a malignancy. It supplements previous guidance on the use of PROs by addressing considerations specific to cancer trials and discusses trial design and labeling considerations when PROs are used to assess a therapy…