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# More Research Needed on Multiple Myeloma PRO Data: CDER
- URL: https://www.fdaweb.com/more-research-needed-on-multiple-myeloma-pro-data-cder/
- Published: 2021-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:13:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150103

CDER researchers say their review of patient-reported outcomes (PROs) in multiple myeloma (MM) registrational trials shows the need for further research to determine the most appropriate approaches for statistical and analytical methodologies for PRO data in MM trials. Writing in *Blood Cancer Journal*, the researchers [say](https://www.nature.com/articles/s41408-021-00543-y?ref=fdaweb.com) they found substantial heterogeneity in terms of PRO collection methods, measures, definitions, and analyses, which may hinder the ability to effectively capture and interpret patient experience in future MM clinical trials. They also found substantially different methods for the handling of missing data and the use of statistical methods for analyses.