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