Welcome To The Estimand: Patient-Reported Outcome Framework Gets Warm Response At FDA/ASCO Workshop
Estimand structure is part of effort to generate standard principles and analyses for patient experience data in oncology and beyond.
You may also be interested in...
Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.
Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
An addendum to the International Council for Harmonisation's guideline on statistical principles for clinical trials proposes a new framework on how the concept of estimands can be used to help clearly describe the effects of a medicine.