IWQOL-Lite-Clinical Trials

• To meet the developmental rigor required by the Food and Drug Administration (FDA) to support product labeling, an alternative version of the IWQOL-Lite questionnaire - IWQOL-Clinical Trials - has been developed and refined through two qualitative studies.
• The IWQOL-Lite-Clinical Trials consists of 20 items optimized for use in the adult patient population typically targeted for obesity clinical trials, both with and without type 2 diabetes.
• Once quantitative data become available, tests of reliability, validity and responsiveness will be conducted and a scoring algorithm will be developed for the IWQOL-Lite-Clinical Trials.
• It is anticipated that the final measure will be qualified by the FDA for use in clinical trials of new weight-loss medications to support product labeling claims.

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