2024
Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies
Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.Peer-Reviewed Original ResearchUS Food and Drug AdministrationFood and Drug AdministrationClinical trialsReference standardDrug AdministrationInternational Federation of Pharmaceutical ManufacturersTrial designPhases of clinical trialsEuropean Medicines AgencyEnrollment targetsPharmaceutical company websitesTrial recruitmentPatient populationImprove patient awarenessInternational FederationMedicines AgencyWorld Health OrganizationEligibility criteriaCompany policiesDiversity policiesStakeholder guidanceTrialsFDAPharmaceutical Research and Manufacturers of AmericaCharacteristics of participants
2023
Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models
Rowhani-Farid A, Grewal M, Solar S, Eghrari A, Zhang A, Gross C, Krumholz H, Ross J. Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models. Scientific Data 2023, 10: 529. PMID: 37553403, PMCID: PMC10409750, DOI: 10.1038/s41597-023-02436-0.Peer-Reviewed Original ResearchMetrics, 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
2021
Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis
Axson S, Mello MM, Lincow D, Yang C, Gross C, Ross JS, Miller J. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open 2021, 11: e053248. PMID: 34281933, PMCID: PMC8291313, DOI: 10.1136/bmjopen-2021-053248.Peer-Reviewed Original Research
2016
Randomized trial assessing the impact of survivorship care plans on the quality of care for childhood cancer survivors.
Gross C, Ross W, Rotatori J, Mitchell H, Ma X, Kadan-Lottick N. Randomized trial assessing the impact of survivorship care plans on the quality of care for childhood cancer survivors. Journal Of Clinical Oncology 2016, 34: 10007-10007. DOI: 10.1200/jco.2016.34.15_suppl.10007.Peer-Reviewed Original ResearchRandomized Trial Of Exercise On Body Composition In Breast Cancer Survivors Taking Aromatase Inhibitors
Thomas G, Cartmel B, Harrigan M, Fiellin M, Capozza S, Zhou Y, Ercolano E, Gross C, Hershman D, Ligibel J, Schmitz K, Li F, Sanft T, Irwin M. Randomized Trial Of Exercise On Body Composition In Breast Cancer Survivors Taking Aromatase Inhibitors. Medicine & Science In Sports & Exercise 2016, 48: 334. DOI: 10.1249/01.mss.0000486010.57056.60.Peer-Reviewed Original Research
2011
Are the Efforts of Current Clinical Trials Involving Radiation Therapy Focused on the Evidence Gaps in Cancer Treatment?
Lloyd S, Gross C, Makarov D, Yu J. Are the Efforts of Current Clinical Trials Involving Radiation Therapy Focused on the Evidence Gaps in Cancer Treatment? International Journal Of Radiation Oncology • Biology • Physics 2011, 81: s139-s140. DOI: 10.1016/j.ijrobp.2011.06.286.Peer-Reviewed Original Research