PROs in Anti-Cancer Trials Should Focus on Five Core Areas, FDA Guidance Says
An FDA draft guidance released last week provides sponsors of anti-cancer therapies with a list of five core areas that patient-reported outcomes (PRO) tools should focus on to demonstrate a therapy’s effect on survival, tumor response or disease progression.
PROs should standardize patients’ reports on the overall impact of side effects by providing them with an objective rating scale. Sponsors also should collect PROs related to the drug’s effect on a patient’s physical and daily life function.
The guidance also addresses the frequency of PRO assessments within cancer trials, recommending that PROs be collected more frequently in the early treatment cycles and then tapered off, if appropriate. Different core PROs may be collected at different frequencies, the guidance says.
Comments on the draft guidance are due by Aug. 9.
Read the FDA’s draft guidance here: https://bit.ly/3pB733L.