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

Department of Clinical Medicine

47 Citations (Scopus)

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
Journal	Pain
Volume	157
Issue number	2
Pages (from-to)	288-301
Number of pages	14
ISSN	0304-3959
DOIs	https://doi.org/10.1097/j.pain.0000000000000375
Publication status	Published - 1 Feb 2016

Keywords

Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Access to Document

10.1097/j.pain.0000000000000375

Cite this

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

@article{5a44f29d13894ca788683482623ddcbc,

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

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 = "Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.",

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",

year = "2016",

month = feb,

day = "1",

doi = "10.1097/j.pain.0000000000000375",

language = "English",

volume = "157",

pages = "288--301",

journal = "Pain",

issn = "0304-3959",

publisher = "IASP Press",

number = "2",

}

TY - JOUR

T1 - Research design considerations for single-dose analgesic clinical trials in acute pain

T2 - IMMPACT recommendations

AU - Cooper, Stephen A

AU - Desjardins, Paul J

AU - Turk, Dennis C

AU - Dworkin, Robert H

AU - Katz, Nathaniel P

AU - Kehlet, Henrik

AU - Ballantyne, Jane C

AU - Burke, Laurie B

AU - Carragee, Eugene

AU - Cowan, Penney

AU - Croll, Scott

AU - Dionne, Raymond A

AU - Farrar, John T

AU - Gilron, Ian

AU - Gordon, Debra B

AU - Iyengar, Smriti

AU - Jay, Gary W

AU - Kalso, Eija A

AU - Kerns, Robert D

AU - McDermott, Michael P

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

PY - 2016/2/1

Y1 - 2016/2/1

N2 - 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.

AB - 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.

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

KW - Research Support, U.S. Gov't, Non-P.H.S.

U2 - 10.1097/j.pain.0000000000000375

DO - 10.1097/j.pain.0000000000000375

M3 - Review

C2 - 26683233

SN - 0304-3959

VL - 157

SP - 288

EP - 301

JO - Pain

JF - Pain

IS - 2

ER -

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

Abstract

Keywords

Access to Document

Fingerprint

Cite this