2022
Diversity in clinical research: public health and social justice imperatives
Varma T, Jones CP, Oladele C, Miller J. Diversity in clinical research: public health and social justice imperatives. Journal Of Medical Ethics 2022, 49: 200-203. PMID: 35428737, DOI: 10.1136/medethics-2021-108068.Peer-Reviewed Original Research
2021
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatients
2015
The 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