Intended for healthcare professionals

Letters FDA on PROMs

Two important points

BMJ 2010; 341 doi: (Published 05 October 2010) Cite this as: BMJ 2010;341:c5454
  1. D Rowen, research fellow ,
  2. J Carlton, research associate,
  3. J E Brazier, professor of health economics,
  4. B Mulhern, research associate,
  5. S Palfreyman, research nurse/honorary lecturer,
  6. K Stevens, research fellow,
  7. A Tsuchiya, reader in economics and health economics
  1. 1Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK
  1. d.rowen{at}

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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