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Page 1 of 3 Recommendations about Translations in the Final FDA Guidance on PRO Measures: What has Changed and What has Remained
Katrin Conway1, Isabelle Méar2 | | |
Keywords: adolescents, health services, research/methods, health status, quality of life, questionnaires
Objective
Almost four years of discussion were necessary to finalize FDA guidance on the use of PRO measures in clinical trials.1,2
Our objective was to compare how the recommendations about translations and cultural adaptation of PRO measures had
evolved from the 2006 draft to the 2009 final guidance.
Methods
The draft and final guidances1,2 were retrieved on the FDA website and analyzed.
Results
Recommendations on translations and cultural adaptation were moved to another section within the Evaluating PRO Instruments Part: from “IV.D. Modification of an existing instrument“ to “III.G. PRO Instruments intended for specific
populations.“ As for the content, the text in the body of the final guidance is more concise compared to the draft guidance. (See Table 1).
New is in the stipulation that the FDA will review the process used to translate/culturally adapt the instruments. As a consequence, an Appendix (section VIII) was added in which the FDA explains which topics should be addressed in the
PRO documents provided to the FDA for review: description of process used, patient testing, rationale for decisions made, copies of versions, and evidence about validity. Mentions about the background of the translators and the harmonization step were deleted in the final version. There is however one key point which did not change: the insistence on the need for providing evidence that content validity and other measurement properties are adequately similar between all versions.
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