One #PeerReview comment on a recent protocol paper was that we should focus less on checklist items required for protocols and write instead about other stuff.

We more or less respectfully declined.

#SPIRITPRO #HRQL #AcademicChatter

In #ISOQOL-s most recent #QualityTALK, a team argues that while such a modular approach has advantages, it complicates the decision of choosing a PROM. The selection should take account of the overall trial objectives and context (e.g., see #ISOQOL, #SPIRITPRO, #SISAQOL) and involve all relevant stakeholders.
https://www.isoqol.org/implementing-the-fdas-draft-guidance-on-core-pros-in-cancer-trials-the-challenge-of-a-modular-approach/

Link to ISOQOL's perspective: https://www.isoqol.org/wp-content/uploads/2023/07/ISOQOL-R_HE-SIG-Comments-on-PFDD-Draft-Guidance-4_Final.pdf
and a commentary presenting the position:
https://link.springer.com/article/10.1007/s11136-023-03396-z

#FDA