2025
An individual-level data synthesis of Clinical Trials Network studies to examine the impact of psychosocial treatments for Black people who use cocaine and/or opioids
Burlew A, Ruglass L, Espinosa A, McCuistian C, Haeny A, Jordan A, Roundtree C, Lopez J, Vena A, Morgan-López A. An individual-level data synthesis of Clinical Trials Network studies to examine the impact of psychosocial treatments for Black people who use cocaine and/or opioids. Drug And Alcohol Dependence 2025, 276: 112850. PMID: 40902223, DOI: 10.1016/j.drugalcdep.2025.112850.Peer-Reviewed Original ResearchCocaine useSocial contextual factorsClinical Trials NetworkNational Drug Abuse Treatment Clinical Trials NetworkSubstance useReduction of cocaine useImpact of psychosocial treatmentsEffects of behavioral treatmentCocaine use severityClinical Trials Network studyTargeting substance useEssential treatment componentMeasurement non-invarianceBlack adultsLong-term reductionRandomized clinical trialsPsychosocial treatmentsBehavioral treatmentTreatment componentsCocaineBehavioral interventionsSeverity Scale scoreLinear mixed modelsComparative effectiveness of treatmentsScale scoreAnesthesiology Clinical Trial Networks in the United States: A Report From the Anesthesia Research Council
Hua M, BillingsIV F, Aziz M, Dutton R, Kheterpal S, Legrand M, Leslie K, Mathew J, McCann M, Subramaniam B, Treggiari M, Wijeysundera D, Gropper M. Anesthesiology Clinical Trial Networks in the United States: A Report From the Anesthesia Research Council. Anesthesia & Analgesia 2025, 141: 522-530. PMID: 40816252, DOI: 10.1213/ane.0000000000007619.Peer-Reviewed Original ResearchClinical Trials NetworkAnesthesiology Clinical Trial Networks in the United States: A Report from the Anesthesia Research Council
Hua M, Billings F, Aziz M, Dutton R, Kheterpal S, Legrand M, Leslie K, Mathew J, McCann M, Subramaniam B, Treggiari M, Wijeysundera D, Gropper M. Anesthesiology Clinical Trial Networks in the United States: A Report from the Anesthesia Research Council. Anesthesiology 2025, 143: 509-517. PMID: 40793804, DOI: 10.1097/aln.0000000000005624.Peer-Reviewed Original ResearchClinical Trials NetworkA phase 2 study of olaparib in IDH1 and IDH2 mutant advanced chondrosarcomas and other solid tumors.
Costa P, Pilat M, Rodon Ahnert J, Burgess M, Tinoco G, Close J, Groisberg R, Subbiah V, Powers B, Haddox C, Grilley-Olson J, Keedy V, Li J, Ivy S, Patel A, Shapiro G, Ishizuka J, Schalper K, LoRusso P. A phase 2 study of olaparib in IDH1 and IDH2 mutant advanced chondrosarcomas and other solid tumors. Journal Of Clinical Oncology 2025, 43: 3087-3087. DOI: 10.1200/jco.2025.43.16_suppl.3087.Peer-Reviewed Original ResearchProgression-free survivalSolid tumorsOverall survivalClinical benefitOpen-label phase II clinical trialSolid tumors refractory to standard treatmentMedian progression-free survivalRefractory to standard treatmentIDH mutant tumorsPhase II clinical trialBRCA-mutated cancersEfficacy of olaparibPhase 2 studyPhase II trialFollow-up timePre-clinical dataII clinical trialsPre-clinical evidenceImpaired homologous recombinationClinical Trials NetworkAdvanced chondrosarcomaMedian OSII trialIDH1/2 mutationsMedian ageA phase 2 study of the olaparib and AZD6738, an ATM/ATR inhibitor, in isocitrate dehydrogenase (IDH) mutant solid tumors.
Costa P, Hafez N, Pilat M, Kalyan A, Azad N, Gore S, Shields A, Al Hallak M, Jin N, Malalur P, Hays J, Rodon Ahnert J, Schalper K, LoRusso P. A phase 2 study of the olaparib and AZD6738, an ATM/ATR inhibitor, in isocitrate dehydrogenase (IDH) mutant solid tumors. Journal Of Clinical Oncology 2025, 43: 3089-3089. DOI: 10.1200/jco.2025.43.16_suppl.3089.Peer-Reviewed Original ResearchProgression-free survivalSolid tumorsOverall survivalClinical benefitOpen-label phase II clinical trialSolid tumors refractory to standard treatmentMedian progression-free survivalRefractory to standard treatmentNational Clinical Trials NetworkPhase II clinical trialCombination of olaparibEfficacy of olaparibLow-grade tumorsLower-grade tumorsPhase 2 studyNCI's National Clinical Trials NetworkFollow-up timePre-clinical dataII clinical trialsIsocitrate dehydrogenase mutationPre-clinical evidenceClinical Trials NetworkMedian OSStable diseaseImpaired homologous recombination repairSummary from the NCI clinical trials planning meeting on next generation of clinical trials in non-muscle invasive bladder cancer *
Apolo A, Baumann B, Al-Ahmadie H, Ballas L, Bangs R, Brothers K, Greenberg S, Delacroix S, Dignam J, Efstathiou J, Feldman A, Foster J, Hahn N, Hall E, Hansel D, Hoffman-Censits J, Kamat A, Kamran S, Khani F, Lerner S, Lipman R, Mann B, McConkey D, McKiernan J, Rose T, Smith A, Tangen C, Amiri A, Weinstock C, West P, Milowsky M, Black P. Summary from the NCI clinical trials planning meeting on next generation of clinical trials in non-muscle invasive bladder cancer *. Bladder Cancer 2025, 11: 23523735251319185. PMID: 40034245, PMCID: PMC11863732, DOI: 10.1177/23523735251319185.Peer-Reviewed Original ResearchNon-muscle invasive bladder cancerClinical Trials Planning MeetingNext generation of clinical trialsGeneration of clinical trialsInvasive bladder cancerClinical trialsNational Cancer InstituteBladder cancerHigh-risk non-muscle invasive bladder cancerNational Clinical Trials NetworkCancer InstituteMultidisciplinary expert consensusClinical trial conceptsClinical trial designClinical Trials NetworkCombination therapyTrial conceptsTrials NetworkExpert consensusTrial designTherapyPlanning meetingsCancerTrialsTask Force
2024
Clinical Trials That Have Changed Clinical Practice and Care of Pregnant People With HIV
Fisher S, Madden N, Espinal M, Garcia P, Jao J, Yee L. Clinical Trials That Have Changed Clinical Practice and Care of Pregnant People With HIV. Clinical Obstetrics & Gynecology 2024, 67: 381-398. PMID: 38450526, DOI: 10.1097/grf.0000000000000860.Peer-Reviewed Original ResearchConceptsPerinatal HIV transmissionRisk of perinatal transmissionObstetric practiceHIV transmissionPerinatal transmissionPregnant peopleRisk of perinatal HIV transmissionPregnant individualsPrelabor cesarean birthBaseline riskIntrapartum administrationCare of HIVViral suppressionInternational Maternal Pediatric Adolescent AIDS Clinical Trials NetworkClinical trialsRates of viral suppressionVaginal birthTime to viral suppressionCesarean birthAdverse pregnancy outcomesRupture of membranesAntiretroviral drug zidovudineClinical Trials NetworkStudy protocolEfavirenz-containing
2023
Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy
Jarrett J, Bratberg J, Burns A, Cochran G, DiPaula B, Dopp A, Elmes A, Green T, Hill L, Homsted F, Hsia S, Matthews M, Ghitza U, Wu L, Bart G. Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy. Substance Abuse 2023, 44: 264-276. PMID: 37902032, PMCID: PMC10870734, DOI: 10.1177/08897077231203849.Peer-Reviewed Original ResearchConceptsOpioid use disorderNational Drug Abuse Treatment Clinical Trials NetworkOUD treatmentCommunity pharmaciesDrug Abuse's National Drug Abuse Treatment Clinical Trials NetworkUse disordersOpioid use disorder treatmentFifth of peoplePrimary care settingBenefits of medicationsClinical Trials NetworkUse disorder treatmentHealth service modelClinical service provisionOpioid overdose crisisPatient populationCommunity pharmacy sectorPatient outcomesCare settingsMOUD servicesDisorder treatmentSynthetic opioidsChain pharmaciesTrials NetworkMOUDThe room where it happens: addressing diversity, equity, and inclusion in National Clinical Trials Network clinical trial leadership
Snyder R, Burtness B, Cho M, Del Rivero J, Doroshow D, Hitchcock K, Kalyan A, Kim C, Lukovic J, Parikh A, Sanford N, Singh B, Shen C, Shroff R, Vijayvergia N, Goodman K, Kunz P. The room where it happens: addressing diversity, equity, and inclusion in National Clinical Trials Network clinical trial leadership. Journal Of The National Cancer Institute 2023, 115: 1132-1138. PMID: 37364007, PMCID: PMC11009492, DOI: 10.1093/jnci/djad121.Peer-Reviewed Original ResearchConceptsNational Clinical Trials NetworkTrial leadershipClinical Trials NetworkDesign of trialsNational Cancer InstituteTask ForceCancer careClinical trialsNovel therapiesGastrointestinal oncologyCancer InstituteTrials NetworkMultidisciplinary investigatorsTrialsCooperative groupsBroader populationCancer researchOncologyNational Institute on Drug Abuse Clinical Trials Network Meeting Report: Advancing Emergency Department Initiation of Buprenorphine for Opioid Use Disorder
Cowan E, Perrone J, Bernstein S, Coupet E, Fiellin D, Hawk K, Herring A, Huntley K, McCormack R, Venkatesh A, D'Onofrio G. National Institute on Drug Abuse Clinical Trials Network Meeting Report: Advancing Emergency Department Initiation of Buprenorphine for Opioid Use Disorder. Annals Of Emergency Medicine 2023, 82: 326-335. PMID: 37178101, PMCID: PMC10524880, DOI: 10.1016/j.annemergmed.2023.03.025.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsOpioid use disorderEmergency departmentUse disordersDrug Abuse Clinical Trials NetworkEffective evidence-based treatmentsEmergency department initiationStandard emergency careMajor public health crisisClinical Trials NetworkEvidence of efficacyNational InstituteEvidence-based treatmentsOpioid overdose deathsTechnology-based interventionsBuprenorphine dosingBuprenorphine initiationPeer-based interventionsPublic health crisisPatient outcomesED staffOverdose deathsEmergency careBuprenorphineTrials NetworkUniversal uptakeNIH HEAL Common Data Elements (CDE) implementation: NIH HEAL Initiative IDEA-CC
Adams M, Hurley R, Siddons A, Topaloglu U, Wandner L, Adams M, Arnsten J, Bao Y, Barry D, Becker W, Fiellin D, Fox A, Ghiroli M, Hanmer J, Horn B, Hurlocker M, Jalal H, Joseph V, Merlin J, Murray-Krezan C, Pearson M, Rogal S, Starrels J, Bachrach R, Witkiewitz K, Vasquez A. NIH HEAL Common Data Elements (CDE) implementation: NIH HEAL Initiative IDEA-CC. Pain Medicine 2023, 24: 743-749. PMID: 36799548, PMCID: PMC10321760, DOI: 10.1093/pm/pnad018.Peer-Reviewed Original ResearchConceptsClinical trialsClinical Trials NetworkCDE programsChronic painSecondary data analysisPainTrials NetworkDisease statesOpioidData standardsGeographical codingClinical researchHealing initiationData elementsNational InstituteTrialsDisordersFederal investmentInterventionStandard processDisorder researchSurveyed librariesCDELeveraging toolsNetwork alignment
2022
Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Rodriguez CP, Kang H, Geiger JL, Burtness B, Chung CH, Pickering CR, Fakhry C, Le QT, Yom SS, Galloway TJ, Golemis E, Li A, Shoop J, Wong S, Mehra R, Skinner H, Saba NF, Flores ER, Myers JN, Ford JM, Karchin R, Ferris RL, Kunos C, Lynn JM, Malik S. Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Journal Of The National Cancer Institute 2022, 114: 1619-1627. PMID: 36053203, PMCID: PMC9745425, DOI: 10.1093/jnci/djac163.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaSquamous cell carcinomaClinical trialsCell carcinomaTrial designTP53 mutationsNational Clinical Trials NetworkMetastatic disease settingsClinical trial developmentClinical Trials NetworkNovel therapeutic approachesNational Cancer InstituteMetastatic headTP53-mutated tumorsWorse outcomesClinical studiesFrequent genetic eventTherapeutic approachesCancer InstituteTrial developmentBreakout groupsPatientsDisease settingsBiomarker integrationTrials NetworkRepresentativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Redman M. Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP). Journal Of Clinical Oncology 2022, 40: 6543-6543. DOI: 10.1200/jco.2022.40.16_suppl.6543.Peer-Reviewed Original ResearchLung-MAPRepresentativeness of patientsNSCLC populationMaster protocolsNSCLC trialsMedicaid/National Clinical Trials NetworkNon-small cell lung cancer trialsSquamous cell lung cancerEnd Results registry dataNovel therapeuticsCell lung cancer trialsCell lung cancerLung cancer trialsClinical Trials NetworkNeighborhood socioeconomic deprivationArea-level measuresOlder patientsMore patientsHispanic patientsRural patientsTrial participationLung cancerTrial findingsCancer trials
2021
Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems
Ali J, Davis AF, Burgess DJ, Rhon DI, Vining R, Young‐McCaughan S, Green S, Kerns RD. Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems. Learning Health Systems 2021, 6: e10291. PMID: 35434355, PMCID: PMC9006531, DOI: 10.1002/lrh2.10291.Peer-Reviewed Original ResearchPragmatic clinical trialsPain management researchIntegrated health systemCo-occurring conditionsHealth systemClinical trialsEvidence-based therapiesClinical Trials NetworkVeterans Health SystemMultidisciplinary working groupPain researchEquitable careStudy settingTrials NetworkHealth inequitiesHealth equityEquitable healthcareHealthcare deliveryPainTrialsWorking GroupRelevant literaturePatientsGroupTherapyFinancial relationships between industry and principal investigators of US cooperative group randomized cancer clinical trials
Metzger AL, Appiah A, Wright CM, Jairam V, Amini A, Park HS, Welsh JW, Thomas CR, Verma V, Ludmir EB. Financial relationships between industry and principal investigators of US cooperative group randomized cancer clinical trials. International Journal Of Cancer 2021, 149: 1683-1690. PMID: 34173669, DOI: 10.1002/ijc.33719.Peer-Reviewed Original ResearchConceptsClinical trialsMultivariable gamma regression analysesNational Clinical Trials NetworkPrincipal investigatorPhase III componentSystemic therapy trialsUS cooperative groupsClinical Trials NetworkCooperative groupsCancer clinical trialsGamma regression analysisSystemic therapySuch RCTsTherapy trialsRCTsTrials NetworkTrialsRegression analysisOne-thirdMedical journalsDrugsP10015/SARC033: A phase 2 trial of trametinib in patients with advanced epithelioid hemangioendothelioma (EHE).
Schuetze S, Ballman K, Ganjoo K, Davis E, Morgan J, Tinoco G, Burgess M, Van Tine B, Choy E, Shepard D, Kelly C, Riedel R, von Mehren M, Siontis B, Attia S, Schwartz G, Deshpande H, Kozlowski E, Chen H, Rubin B. P10015/SARC033: A phase 2 trial of trametinib in patients with advanced epithelioid hemangioendothelioma (EHE). Journal Of Clinical Oncology 2021, 39: 11503-11503. DOI: 10.1200/jco.2021.39.15_suppl.11503.Peer-Reviewed Original ResearchObjective response ratePhase 2 trialEpithelioid hemangioendotheliomaObjective responseLarge prospective clinical studiesGI adverse effectsMetastatic epithelioid hemangioendotheliomaObjective tumor progressionPrimary trial endpointNausea/vomitingWeeks of therapyBiomarkers of inflammationProspective clinical studyTreatment of patientsClinical Trials NetworkCommon AEsMedian PFSOS ratesPt ageStable diseasePain scoresAdverse eventsMetastatic diseasePain intensityIndolent growthA phase 1b study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO).
Dumbrava E, Dougan M, Gupta S, Cappelli L, Katsumoto T, Rahma O, Painter J, Wang Y, Suarez-Almazor M, Reid P, Wesley S, Hafler D, Bingham C, Warner B, Chung L, Ott P, Kluger H, Khosroshahi A, Tawbi H, Sharon E. A phase 1b study of nivolumab in patients with autoimmune disorders and advanced malignancies (AIM-NIVO). Journal Of Clinical Oncology 2021, 39: tps2676-tps2676. DOI: 10.1200/jco.2021.39.15_suppl.tps2676.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsDisease-specific cohortsAutoimmune disordersAdverse eventsAdvanced malignanciesAnti-PD-1/PD-L1 antibodiesPre-existing autoimmune disordersAnti-PD1 monoclonal antibodiesImpact of nivolumabPhase 1b studyKey secondary endpointPhase Ib studySerious adverse eventsDose-limiting toxicityInflammatory bowel diseasePD-L1 antibodiesSeverity IndexSystemic lupus erythematosusDysfunctional immune systemClinical Trials NetworkTissue-based biomarkersSpecific eligibility criteriaICI therapyPrimary endpointSecondary endpoints
2020
Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol
Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol. The Lancet Oncology 2020, 21: 1589-1601. PMID: 33125909, PMCID: PMC8109255, DOI: 10.1016/s1470-2045(20)30475-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Decision-MakingDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingPrecision MedicinePredictive Value of TestsProgression-Free SurvivalTime FactorsYoung AdultConceptsCell lung cancerNational Cancer InstituteTargeted therapy groupLung cancerLung-MAPMaster protocolsDocetaxel groupTherapy groupEastern Cooperative Oncology Group performance statusUnmet needMedian progression-free survivalNational Clinical Trials NetworkMedian overall survivalAdvanced lung cancerProgression-free survivalPlatinum-based chemotherapyClinical Trials NetworkNational InstituteClinical trial componentUS National Cancer InstituteNew screening protocolBristol-Myers SquibbAdditional substudyEligible patientsImmunotherapy combinationsHispanic participants in the National Institute on Drug Abuse’s Clinical Trials Network: A scoping review of two decades of research
Eghaneyan BH, Sanchez K, Haeny AM, Montgomery L, Lopez-Castro T, Burlew AK, Rezaeizadeh A, Killian MO. Hispanic participants in the National Institute on Drug Abuse’s Clinical Trials Network: A scoping review of two decades of research. Addictive Behaviors Reports 2020, 12: 100287. PMID: 32637563, PMCID: PMC7330873, DOI: 10.1016/j.abrep.2020.100287.Peer-Reviewed Original ResearchClinical Trials NetworkSubstance abuse treatmentTreatment outcomesNational Drug Abuse Treatment Clinical Trials NetworkTrials NetworkAbuse treatmentDrug Abuse Clinical Trials NetworkEffective interventionsPoor treatment outcomesHispanic populationSubstance use disordersPatient characteristicsClinical trialsTobacco useTreatment accessUse disordersHispanic participantsGreater riskTreatment participationSystematic searchSubstance useTreatment issuesRelevant studiesInfluence utilizationLess likelihoodLung-MAP (SWOG S1400): Design, implementation, and lessons learned from a biomarker-driven master protocol (BDMP) for previously-treated squamous lung cancer (sqNSCLC).
Redman M, Papadimitrakopoulou V, Minichiello K, Gandara D, Hirsch F, Mack P, Schwartz L, Vokes E, Ramalingam S, Leighl N, Bradley J, LeBlanc M, Malik S, Miller V, Sigal E, Adam S, Blanke C, Kelly K, Herbst R. Lung-MAP (SWOG S1400): Design, implementation, and lessons learned from a biomarker-driven master protocol (BDMP) for previously-treated squamous lung cancer (sqNSCLC). Journal Of Clinical Oncology 2020, 38: 9576-9576. DOI: 10.1200/jco.2020.38.15_suppl.9576.Peer-Reviewed Original ResearchBiomarker-driven studiesLung-MAPNational Clinical Trials NetworkClinical Trials NetworkSquamous lung cancerNational Cancer InstituteLung cancerTherapy questionsCancer InstituteUnmet needSuccess of PDMaster protocolsTrials NetworkPatientsBiomarker resultsSqNSCLCRegulatory approvalTherapyDurvalumabIpilimumabNivolumabTrial partsFoundationOneNSCLCS1400
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