Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials - 04/04/23
, Raissa Lou †, #, Soun Sheen †, Dagmar Amtmann ‡, Luana Colloca §, Robert R. Edwards ¶, John T. Farrar ‖, Nathaniel P. Katz ⁎⁎, Michael P. McDermott †, Bryce B. Reeve ††, Ajay D. Wasan ‡‡, Dennis C. Turk ‡, Robert H. Dworkin †, Jennifer S. Gewandter †Highlights |
• | 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. |
Abstract |
Variability in pain-related outcomes can hamper assay sensitivity of chronic pain clinical trials. Expectations of outcome in such trials may account for some of this variability, and thereby impede development of novel pain treatments. Measurement of participants’ expectations prior to initiating study treatment (active or placebo) is infrequent, variable, and often unvalidated. Efforts to optimize and standardize measurement, analysis, and management of expectations are needed. In this Focus Article, we provide an overview of research findings on the relationship between baseline expectations and pain-related outcomes in clinical trials of pharmacological and nonpharmacological pain treatments. We highlight the potential benefit of adjusting for participants’ expectations in clinical trial analyses and draw on findings from patient interviews to discuss critical issues related to measurement of expectations. We conclude with suggestions regarding future studies focused on better understanding the utility of incorporating these measures into clinical trial analyses.
Perspective |
This focus article provides an overview of the relationship between participants’ baseline expectations and pain-related outcomes in the setting of clinical trials of chronic pain treatments. Systematic research focused on the measurement of expectations and the impact of adjusting for expectations in clinical trial analyses may improve assay sensitivity.
Le texte complet de cet article est disponible en PDF.Key Words : Outcome expectations, chronic pain, clinical trials, covariate adjustment, assay sensitivity
Plan
| 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. |
Vol 24 - N° 4
P. 575-581 - avril 2023 Retour au numéro
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