Featured Publications
The 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 trialsJustificationClaims
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