2024
A single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer
Verma N, Johung K, Kortmansky J, Zaheer W, Lacy J, Cecchini M, Stein S, Cheng Y, Lam W, Liu S, Reddy V, Hochster H, Higgins S. A single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer. Journal Of Gastrointestinal Oncology 2024, 15: 1050-1059. PMID: 38989411, PMCID: PMC11231844, DOI: 10.21037/jgo-24-23.Peer-Reviewed Original Research
2021
Publication Bias in Gastrointestinal Oncology Trials Performed over the Past Decade
Peters GW, Tao W, Wei W, Miccio JA, Jethwa KR, Cecchini M, Johung KL. Publication Bias in Gastrointestinal Oncology Trials Performed over the Past Decade. The Oncologist 2021, 26: 660-667. PMID: 33728733, PMCID: PMC8342580, DOI: 10.1002/onco.13759.Peer-Reviewed Original ResearchConceptsGI oncologyPublication biasImpact of RCTsFuture trial designMultivariable logistic regressionSignificant publication biasPast trialsAccrual completionCancer RCTsEvidence-based practiceGastrointestinal cancerClinical managementTrial completionTrial designOncology trialsClinical practicePublication statusRCTsTrial questionModern RCTsLogistic regressionHalf of trialsTrialsPhase IIIGold standard
2019
Challenges with Novel Clinical Trial Designs: Master Protocols
Cecchini M, Rubin EH, Blumenthal GM, Ayalew K, Burris HA, Russell-Einhorn M, Dillon H, Lyerly HK, Reaman GH, Boerner S, LoRusso PM. Challenges with Novel Clinical Trial Designs: Master Protocols. Clinical Cancer Research 2019, 25: 2049-2057. PMID: 30696689, DOI: 10.1158/1078-0432.ccr-18-3544.Peer-Reviewed Original ResearchConceptsClinical trial designPlatform trialsMaster protocolsUmbrella trialsTrial designBasket trialsNovel clinical trial designsPanel of expertsMultiple investigational agentsInnovative clinical trial designsNovel clinical trialsInstitutional review boardDifferent tumor typesExpansion cohortInvestigational agentsSame histologyClinical trialsTumor typesBasket studyPatientsReview boardTrialsDrug development processDrug assessmentHistology