Letters
FDA on PROMs
Two important points
BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c5454 (Published 05 October 2010) Cite this as: BMJ 2010;341:c5454
- D Rowen, research fellow ,
- J Carlton, research associate,
- J E Brazier, professor of health economics,
- B Mulhern, research associate,
- S Palfreyman, research nurse/honorary lecturer,
- K Stevens, research fellow,
- A Tsuchiya, reader in economics and health economics
- 1Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK
- d.rowen{at}sheffield.ac.uk
The new Food and Drug Administration (FDA) guidance on patient reported outcome measures (PROMs)1 2 will affect the use of PROMs in clinical trials and thus the evidence available to licensing and reimbursement authorities worldwide.
We have two comments. Firstly, the guidance …
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