Featured Publications
Social and Scientific History of Randomized Controlled Trials
Bothwell L, Kuo W, Jones D, Podolsky S. Social and Scientific History of Randomized Controlled Trials. 2020, 1-17. DOI: 10.1007/978-3-319-52677-5_196-1.Peer-Reviewed Original ResearchSocietal forcesTechnological forcesEthical standardsHistorical contextScientific historyGenerations of investigatorsRigorous research methodsConceptual foundationsResearch methodsCommercial interestRecent expansionKey challengesChapter brieflyChallengesHistoryForceContextTrials todayPracticeFoundationEmergenceTodayHistorical useRigorInnovation and Tribulation in the History of Randomized Controlled Trials in Surgery
Bothwell L, Jones D. Innovation and Tribulation in the History of Randomized Controlled Trials in Surgery. Annals Of Surgery 2019, 274: e616-e624. PMID: 34784667, PMCID: PMC8600053, DOI: 10.1097/sla.0000000000003631.Peer-Reviewed Original ResearchThe Real‐World Ethics of Adaptive‐Design Clinical Trials
Bothwell LE, Kesselheim AS. The Real‐World Ethics of Adaptive‐Design Clinical Trials. The Hastings Center Report 2017, 47: 27-37. PMID: 29171051, DOI: 10.1002/hast.783.Peer-Reviewed Original ResearchConceptsClinical equipoisePrimary ethical concernsMedical researchEthical approachEthical argumentsEthical justificationTrial control armEthical concernsEthicsAdaptive design clinical trialsTheoretical equipoiseCritical principlesEquipoiseAllocation of subjectsInferior treatmentProduct sponsorsArgumentCritical assessmentConventional RCTsAdditional concernsUseful standardActual trialAdaptive trialsJustificationClaimsAssessing the Gold Standard — Lessons from the History of RCTs
Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard — Lessons from the History of RCTs. New England Journal Of Medicine 2016, 374: 2175-2181. PMID: 27248626, DOI: 10.1056/nejmms1604593.Peer-Reviewed Original Research
2022
Trends in disparities in COVID hospitalizations among community‐dwelling residents of two counties in Connecticut, before and after vaccine introduction, March 2020–September 2021
McWilliams C, Bothwell L, Yousey‐Hindes K, Hadler J. Trends in disparities in COVID hospitalizations among community‐dwelling residents of two counties in Connecticut, before and after vaccine introduction, March 2020–September 2021. Influenza And Other Respiratory Viruses 2022, 17: e13082. PMID: 36509459, PMCID: PMC9835416, DOI: 10.1111/irv.13082.Peer-Reviewed Original ResearchConceptsCOVID-19 hospitalizationNon-Hispanic blacksGeocoded residential addressesAge-adjusted incidenceNon-Hispanic whitesHispanic/LatinxVaccination ratesLaboratory-confirmed COVID-19Residential addressesSocioeconomic statusSurveillance Network databaseCommunity-dwelling residentsNon-institutionalized personsIntroduction of vaccinesLow socioeconomic statusCensus tract measuresRace/ethnicityLower SES groupsVaccine registryVaccine introductionVaccination levelsHospitalizationVaccine rolloutDelta wavesSES disparitiesSocial and Scientific History of Randomized Controlled Trials
Bothwell L, Kuo W, Jones D, Podolsky S. Social and Scientific History of Randomized Controlled Trials. 2022, 3-19. DOI: 10.1007/978-3-319-52636-2_196.Peer-Reviewed Original ResearchSocietal forcesTechnological forcesEthical standardsHistorical contextScientific historyGenerations of investigatorsRigorous research methodsConceptual foundationsResearch methodsCommercial interestRecent expansionKey challengesChapter brieflyChallengesHistoryForceContextTrials todayPracticeFoundationEmergenceTodayHistorical useRigor
2021
Bioethical Issues in Pharmacoepidemiologic Research
Bothwell L, Richterich A, Greene J. Bioethical Issues in Pharmacoepidemiologic Research. 2021, 276-293. DOI: 10.1002/9781119701101.ch16.Peer-Reviewed Original ResearchField of bioethicsResearch ethics policiesGood Pharmacoepidemiology PracticesPharmacoepidemiologic researchEthical conceptsEthics policiesEthical policiesBioethical issuesBioethical principlesField of pharmacoepidemiologyInternational SocietyGlobal settingBioethicsPolicyPracticeConductKey elementsEuropean NetworkMedical therapeuticsSocietyKey challengesConceptPrinciplesResearchRecent developmentsInnovation and Tribulation in the History of Randomized Controlled Trials in Surgery
Bothwell LE, Jones DS. Innovation and Tribulation in the History of Randomized Controlled Trials in Surgery. Annals of Surgery 2021, 274 (6): e616-e624.Peer-Reviewed Original Research
2020
Social and Scientific History of Randomized Controlled Trials
Bothwell LE, Kuo W-H, Jones DS, Podolsky, SH. Social and Scientific History of Randomized Controlled Trials. In Principles and Practice of Clinical Trials. Ed. S. Piantadosi and C. Meinert. Springer, 2020.Books
2019
Bioethical Issues in Pharmacoepidemiologic Research
Bothwell L, Richterich A, Greene J. Bioethical Issues in Pharmacoepidemiologic Research. 2019, 772-791. DOI: 10.1002/9781119413431.ch31.Peer-Reviewed Original ResearchBioethical issuesField of bioethicsTechnologies of surveillancePharmacoepidemiologic researchSociological perspectiveEthical approachSociological dimensionsBioethical principlesField of pharmacoepidemiologyNational variationsInternational perspectivePerspectiveChapter brieflyBioethicsIssuesResearchMedical therapeuticsAttentionRecent yearsCommonalitiesPrinciplesData analysisRecent developmentsBrieflyDimensionsBioethical Issues in Pharmacoepidemiologic Research
Bothwell LE, Richterich A, Greene, JA. Bioethical Issues in Pharmacoepidemiologic Research. In Pharmacoepidemiology, 6th Edition. Ed. B. L. Strom, S. E. Kimmel, and S. Hennessy. Hoboken: Wiley, 2019.Books
2018
Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov
Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov. BMJ Open 2018, 8: e018320. PMID: 29440155, PMCID: PMC5829673, DOI: 10.1136/bmjopen-2017-018320.Peer-Reviewed Original ResearchConceptsIndependent data monitoring committeeData monitoring committeeDesign clinical trialEuropean Medicines AgencyClinical trialsInterim analysisAdaptive design clinical trialsPhase I/II trialPhase II/IIIAdaptive trialsControlled Clinical TrialsBasic study characteristicsWeb of ScienceII trialCochrane RegistryInclusion criteriaDose-finding designDrug AdministrationMedicines AgencyStudy characteristicsSuch trialsMonitoring committeeAdaptive design featuresPhase ITrials
2016
The Emergence of the Randomized, Controlled Trial
Bothwell LE, Podolsky SH. The Emergence of the Randomized, Controlled Trial. New England Journal Of Medicine 2016, 375: 501-504. PMID: 27509097, DOI: 10.1056/nejmp1604635.Peer-Reviewed Original Research