Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Stephen A. Cooper; Paul J. Desjardins; Dennis C. Turk; Robert H. Dworkin; Nathaniel P. Katz; Henrik Kehlet; Jane C. Ballantyne; Laurie B. Burke; Eugene Carragee; Penney Cowan; Scott Croll; Raymond A. Dionne; John T. Farrar; Ian Gilron; Debra B. Gordon; Smriti Iyengar; Gary W. Jay; Eija A. Kalso; Robert D. Kerns; Michael P. Mcdermott; Srinivasa N. Raja; Bob A. Rappaport; Christine Rauschkolb; Mike A. Royal; Märta Segerdahl; Joseph W. Stauffer; Knox H. Todd; Geertrui F. Vanhove; Mark S. Wallace; Christine West; Richard E. White; Christopher Wu

doi:10.1097/j.pain.0000000000000375

Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Stephen A. Cooper, Paul J. Desjardins, Dennis C. Turk, Robert H. Dworkin, Nathaniel P. Katz, Henrik Kehlet, Jane C. Ballantyne, Laurie B. Burke, Eugene Carragee, Penney Cowan, Scott Croll, Raymond A. Dionne, John T. Farrar, Ian Gilron, Debra B. Gordon, Smriti Iyengar, Gary W. Jay, Eija A. Kalso, Robert D. Kerns, Michael P. McdermottSrinivasa N. Raja, Bob A. Rappaport, Christine Rauschkolb, Mike A. Royal, Märta Segerdahl, Joseph W. Stauffer, Knox H. Todd, Geertrui F. Vanhove, Mark S. Wallace, Christine West, Richard E. White, Christopher Wu

Research output: Contribution to journal › Review article › peer-review

85 Scopus citations

Abstract

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

Original language	English (US)
Pages (from-to)	288-301
Number of pages	14
Journal	Pain
Volume	157
Issue number	2
DOIs	https://doi.org/10.1097/j.pain.0000000000000375
State	Published - Feb 1 2016

Keywords

Acute pain
Assay sensitivity
Clinical trial methods
Proof-of-concept trials
Randomized clinical trials
Research design

ASJC Scopus subject areas

Neurology
Clinical Neurology
Anesthesiology and Pain Medicine

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10.1097/j.pain.0000000000000375

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Cooper, S. A., Desjardins, P. J., Turk, D. C., Dworkin, R. H., Katz, N. P., Kehlet, H., Ballantyne, J. C., Burke, L. B., Carragee, E., Cowan, P., Croll, S., Dionne, R. A., Farrar, J. T., Gilron, I., Gordon, D. B., Iyengar, S., Jay, G. W., Kalso, E. A., Kerns, R. D., ... Wu, C. (2016). Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations. Pain, 157(2), 288-301. https://doi.org/10.1097/j.pain.0000000000000375

Cooper, SA, Desjardins, PJ, Turk, DC, Dworkin, RH, Katz, NP, Kehlet, H, Ballantyne, JC, Burke, LB, Carragee, E, Cowan, P, Croll, S, Dionne, RA, Farrar, JT, Gilron, I, Gordon, DB, Iyengar, S, Jay, GW, Kalso, EA, Kerns, RD, Mcdermott, MP, Raja, SN, Rappaport, BA, Rauschkolb, C, Royal, MA, Segerdahl, M, Stauffer, JW, Todd, KH, Vanhove, GF, Wallace, MS, West, C, White, RE & Wu, C 2016, 'Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations', Pain, vol. 157, no. 2, pp. 288-301. https://doi.org/10.1097/j.pain.0000000000000375

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abstract = "This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.",

keywords = "Acute pain, Assay sensitivity, Clinical trial methods, Proof-of-concept trials, Randomized clinical trials, Research design",

author = "Cooper, {Stephen A.} and Desjardins, {Paul J.} and Turk, {Dennis C.} and Dworkin, {Robert H.} and Katz, {Nathaniel P.} and Henrik Kehlet and Ballantyne, {Jane C.} and Burke, {Laurie B.} and Eugene Carragee and Penney Cowan and Scott Croll and Dionne, {Raymond A.} and Farrar, {John T.} and Ian Gilron and Gordon, {Debra B.} and Smriti Iyengar and Jay, {Gary W.} and Kalso, {Eija A.} and Kerns, {Robert D.} and Mcdermott, {Michael P.} and Raja, {Srinivasa N.} and Rappaport, {Bob A.} and Christine Rauschkolb and Royal, {Mike A.} and M{\"a}rta Segerdahl and Stauffer, {Joseph W.} and Todd, {Knox H.} and Vanhove, {Geertrui F.} and Wallace, {Mark S.} and Christine West and White, {Richard E.} and Christopher Wu",

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AU - Katz, Nathaniel P.

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AU - Ballantyne, Jane C.

AU - Burke, Laurie B.

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AU - Croll, Scott

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AU - Raja, Srinivasa N.

AU - Rappaport, Bob A.

AU - Rauschkolb, Christine

AU - Royal, Mike A.

AU - Segerdahl, Märta

AU - Stauffer, Joseph W.

AU - Todd, Knox H.

AU - Vanhove, Geertrui F.

AU - Wallace, Mark S.

AU - West, Christine

AU - White, Richard E.

AU - Wu, Christopher

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Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Abstract

Keywords

ASJC Scopus subject areas

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