2016
Research design considerations for single-dose analgesic clinical trials in acute pain
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. Research design considerations for single-dose analgesic clinical trials in acute pain. Pain 2016, 157: 288-301. PMID: 26683233, DOI: 10.1097/j.pain.0000000000000375.Peer-Reviewed Original ResearchConceptsClinical trialsEarly phase clinical trialsAcute pain studiesAcute pain trialsPain clinical trialsAnalgesic clinical trialsPhase clinical trialsShort-duration trialsPostoperative painAcute painPain trialsPain assessmentStudy design factorsPain studiesDental impactionStudy designTrialsPainAssessment measuresResearch design considerationsPlaceboSurgeryBunionectomyDifferent settings
2012
Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations
Dworkin RH, Turk DC, Peirce-Sandner S, Burke LB, Farrar JT, Gilron I, Jensen MP, Katz NP, Raja SN, Rappaport BA, Rowbotham MC, Backonja M, Baron R, Bellamy N, Bhagwagar Z, Costello A, Cowan P, Fang WC, Hertz S, Jay GW, Junor R, Kerns RD, Kerwin R, Kopecky EA, Lissin D, Malamut R, Markman JD, McDermott MP, Munera C, Porter L, Rauschkolb C, Rice ASC, Sampaio C, Skljarevski V, Sommerville K, Stacey BR, Steigerwald I, Tobias J, Trentacosti AM, Wasan AD, Wells GA, Williams J, Witter J, Ziegler D. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain 2012, 153: 1148-1158. PMID: 22494920, DOI: 10.1016/j.pain.2012.03.003.Peer-Reviewed Original ResearchConceptsRecent randomized clinical trialsClinical trialsAnalgesic treatmentChronic pain clinical trialsPain clinical trialsAnalgesic drug developmentChronic pain treatmentChronic pain trialsRandomized clinical trialsAnalgesic clinical trialsNumber of patientsEvidence-based approachIMMPACT recommendationsPain treatmentPain trialsPharmacologic treatmentAnalgesic trialsPain assessmentAssay sensitivityEfficacious medicationsConsensus meetingNegative trialsImproved efficacyStudy designTrials
2010
Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations
Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomäki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath PJ, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve BB, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain 2010, 149: 177-193. PMID: 20207481, DOI: 10.1016/j.pain.2010.02.018.Peer-Reviewed Original ResearchConceptsChronic pain clinical trialsPain clinical trialsClinical trialsPrimary efficacy analysisChronic pain trialsDemonstration of efficacyIMMPACT recommendationsResearch design considerationsAnalgesic effectPain trialsChronic painEfficacy analysisTypes of trialsConsensus meetingTreatment groupsNew interventionsTrue lackTrialsTrial phaseEfficacyMethodological weaknessesAssay sensitivityTreatmentSubstantial variabilityParticipant selection