Gatekeepers for pragmatic clinical trials
Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clinical Trials 2015, 12: 442-448. PMID: 26374683, PMCID: PMC4592478, DOI: 10.1177/1740774515597699.Peer-Reviewed Original ResearchThe ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
Welch MJ, Lally R, Miller JE, Pittman S, Brodsky L, Caplan AL, Uhlenbrauck G, Louzao DM, Fischer JH, Wilfond B. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials 2015, 12: 503-510. PMID: 26374681, PMCID: PMC4662375, DOI: 10.1177/1740774515597701.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsClinical trialsPregnant womenVulnerable populationsClinical trial settingsMental disabilitiesPhysical handicapTraditional clinical trialsDisadvantaged personsVulnerable subjectsTrial settingsHealth interventionsClinical settingClinical researchTrialsNeonatesFetusesWomenSubjectsDisabilityChildrenVulnerable research subjectsPopulationSpecific recommendationsPersons