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
2014
Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: An ACTTION study
Farrar JT, Troxel AB, Haynes K, Gilron I, Kerns RD, Katz NP, Rappaport BA, Rowbotham MC, Tierney AM, Turk DC, Dworkin RH. Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: An ACTTION study. Pain 2014, 155: 1622-1631. PMID: 24831421, DOI: 10.1016/j.pain.2014.05.009.Peer-Reviewed Original ResearchConceptsDiabetic peripheral neuropathyLikelihood of responseClinical trialsPostherpetic neuralgiaPainful diabetic peripheral neuropathyAddiction Clinical Trial TranslationsNetworks (ACTTION) public-private partnershipBaseline pain levelsPlacebo-treated groupRandomized clinical trialsAnalgesic clinical trialsPatient-level dataClinical trial dataExploratory logistic regressionAvailable baseline factorsNeuropathic painPain diaryPain levelsBaseline factorsPain therapyPeripheral neuropathyPatient sexPatients' baselinePain ratingsStudy protocol
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