2023
Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study
Varma T, Mello M, Ross J, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Medicine 2023, 2: e000395. PMID: 36936269, PMCID: PMC9951369, DOI: 10.1136/bmjmed-2022-000395.Peer-Reviewed Original ResearchRetrospective cross-sectional studyCross-sectional studyPivotal trialsOlder adultsSectional studyNovel oncology therapeuticsUS cancer populationUS Cancer StatisticsUS patient populationAmerican Cancer SocietyPatient populationCancer populationOncology therapeuticsCancer SocietyCancer statisticsNovel cancer therapeuticsOncology trialsBaseline scoresPatientsUS FoodDrug AdministrationTrial dataStudy participantsTrialsEthics Committee
2022
Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE
Manyara AM, Davies P, Stewart D, Weir CJ, Young A, Butcher NJ, Bujkiewicz S, Chan AW, Collins GS, Dawoud D, Offringa M, Ouwens M, Ross JS, Taylor RS, Ciani O. Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open 2022, 12: e064304. PMID: 36220321, PMCID: PMC9557267, DOI: 10.1136/bmjopen-2022-064304.Peer-Reviewed Original ResearchConceptsSurrogate endpointsPeer-reviewed publicationsSurrogate primary endpointOpen-access peer-reviewed publicationPATIENTS/PARTICIPANTSCompleteness of reportingTranslation of effectsPhase 1Primary endpointPrimary outcomeTrial findingsEthical approvalCONSORT extensionSuch trialsEthics CommitteeEndpointHealth benefitsTrialsPhase 3Final outcomePhase 2Transparent reportingOutcomesPhase 4Additional items