2023
Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement
Hohenschurz-Schmidt D, Cherkin D, Rice A, Dworkin R, Turk D, McDermott M, Bair M, DeBar L, Edwards R, Farrar J, Kerns R, Markman J, Rowbotham M, Sherman K, Wasan A, Cowan P, Desjardins P, Ferguson M, Freeman R, Gewandter J, Gilron I, Grol-Prokopczyk H, Hertz S, Iyengar S, Kamp C, Karp B, Kleykamp B, Loeser J, Mackey S, Malamut R, McNicol E, Patel K, Sandbrink F, Schmader K, Simon L, Steiner D, Veasley C, Vollert J. Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement. Pain 2023, 164: 1457-1472. PMID: 36943273, PMCID: PMC10281023, DOI: 10.1097/j.pain.0000000000002888.Peer-Reviewed Original ResearchConceptsPragmatic trialPain treatmentClinical careSystematic reviewAddiction Clinical Trial TranslationsNetworks (ACTTION) public-private partnershipTraditional efficacy trialsRoutine clinical careDaily clinical carePragmatic clinical trialsEvidence-based treatmentsRelated health policiesInternal validityPain assessmentClinical managementClinical trialsEfficacy trialsConsensus meetingTrial designConsensus discussionTrial objectivesSuch trialsHealth policyTrialsExpert presentations
2014
Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations
Gewandter JS, Dworkin RH, Turk DC, McDermott MP, Baron R, Gastonguay MR, Gilron I, Katz NP, Mehta C, Raja SN, Senn S, Taylor C, Cowan P, Desjardins P, Dimitrova R, Dionne R, Farrar JT, Hewitt DJ, Iyengar S, Jay GW, Kalso E, Kerns RD, Leff R, Leong M, Petersen KL, Ravina BM, Rauschkolb C, Rice ASC, Rowbotham MC, Sampaio C, Sindrup S, Stauffer JW, Steigerwald I, Stewart J, Tobias J, Treede RD, Wallace M, White RE. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain 2014, 155: 1683-1695. PMID: 24865794, PMCID: PMC4500524, DOI: 10.1016/j.pain.2014.05.025.Peer-Reviewed Original ResearchConceptsClinical trialsPain treatmentConfirmatory trialsPOC trialsChronic pain clinical trialsEfficacious pain treatmentsPain clinical trialsSingle-dose studyChronic pain treatmentConcept clinical trialPharmacokinetic-pharmacodynamic relationshipsSequential parallel comparison designIMMPACT recommendationsActive comparatorPatient populationConsensus meetingIneffective treatmentRapid onsetTrial designNovel treatmentsCrossover designTrial durationTrialsEnriched designStudy power
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