- •Participants’ outcome expectations may contribute to clinical trial outcome variability.
- •Outcome expectations are influenced by a number of factors.
- •A brief, content-valid measure of outcome expectations is needed.
- •Adjusting for expectations in clinical trial analyses may improve assay sensitivity.
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Financial support for this article was provided by a NIH K award (K24NS126861; JSG) and the ACTTION public-private partnership with the FDA (U01FD007474; RHD), which has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, and other sources. No official endorsement by the FDA or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION should be inferred. JTF reports over the past 3 years funding from NIH-NCATS – UL1 Grant (Co-I), NIH-NIDDK - U01 Grant (CoI), from NIH-NINDS - U24 Grant (PI), and two FDA-BAA Contracts; and compensation for serving on two NIH DSMBs and advisory boards or consulting on clinical trial methods from Vertex and Lilly. During than the past 3 years, DCT has received research grants and contracts from the US Food and Drug Administration and US National Institutes of Health and has received compensation for consulting on clinical trial and patient preferences from Eli Lilly & Company, Flexion, Novartis/GlaxoSmithKline, and Pfizer. RHD has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, Beckley, Biogen, Biohaven, Biosplice, Boston Scientific, Braeburn, Cardialen, Celgene, Centrexion, Chiesi, Chromocell, Clexio, Collegium, Concert, Confo, Decibel, Editas, Eli Lilly, Endo, Ethismos (equity), Eupraxia, Exicure, Glenmark, Gloriana, Grace, Hope, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, OCT, OliPass, Pfizer, Q-State, Reckitt Benckiser, Regenacy (also equity), Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Biopharmaceuticals, Sollis, SPRIM, Teva, Theranexus, Toray, Vertex, Vizuri, and WCG. The remaining authors report no conflicts of interest related to this work.