Joshua J. Skydel, MD
Clinical FellowDownloadHi-Res Photo
Cards
Education
MD
Tufts University School of Medicine (2021)
Tufts University School of Medicine (2021)
BS (Hon)
University of Connecticut, Biological Sciences (2016)
University of Connecticut, Biological Sciences (2016)
Training
Clinical and Research Fellow
Yale-New Haven Hospital (2027)
Yale-New Haven Hospital (2027)
Resident
Dartmouth Hitchcock Medical Center (2024)
Dartmouth Hitchcock Medical Center (2024)
About
Titles
Clinical Fellow
Biography
Joshua Skydel, MD, attended Tufts University School of Medicine, earning his medical degree in 2021. He completed his residency in internal medicine at Dartmouth Hitchcock Medical Center before joining the Yale Rheumatology fellowship program in 2024. Dr. Skydel's research interests include US pharmaceutical policy and "meta-research" into the role of real-world evidence to support the use of new therapies, including disease-modifying antirheumatic drugs. With members of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), he has published on the US Food and Drug Administration's use of expedited review programs and postmarketing actions, as well as enrollment patterns for clinical trials investigating new lupus therapies.
Departments & Organizations
- Rheumatology, Allergy, & Immunology
Education & Training
- Clinical and Research Fellow
- Yale-New Haven Hospital (2027)
- Resident
- Dartmouth Hitchcock Medical Center (2024)
- MD
- Tufts University School of Medicine (2021)
- BS (Hon)
- University of Connecticut, Biological Sciences (2016)
Board Certifications
Internal Medicine
- Certification Organization
- American Board of Internal Medicine
- Original Certification Date
- 2024
Research
Overview
Medical Research Interests
Rheumatology; United States Food and Drug Administration
Public Health Interests
Health Policy; Pharmaceuticals and Medical Devices; Regulatory Affairs
ORCID
0000-0002-3527-4277
Research at a Glance
Research Interests
Research topics Joshua J. Skydel is interested in exploring.
United States Food and Drug Administration
Publications
2024
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study
Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.Peer-Reviewed Original ResearchAltmetricConceptsNational Comprehensive Cancer NetworkNational Comprehensive Cancer Network guidelinesComprehensive Cancer NetworkFood and Drug AdministrationCancer NetworkUS Food and Drug AdministrationCategories of evidenceAccelerated approvalCross sectional studyDrug treatmentConfirmatory trialsClinical benefitTrial resultsOncological indicationsTraditional approvalGuideline recommendationsOutcome measuresSectional studyApproval statusFDA decisionRecommended alignmentOncologyUpdate recommendationsPostapproval trialsGuidelines
2023
Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies
Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.Peer-Reviewed Original ResearchAltmetricWant to make drugs, including insulin, affordable? End patent abuse.
Skydel J, Ramachandran R. Want to make drugs, including insulin, affordable? End patent abuse. The Baltimore Sun. 03/03/2023. https://www.baltimoresun.com/opinion/op-ed/bs-ed-op-0306-pharmaceutical-patent-abuse-20230303-i5m23qxza5dkfd2oji5fv3v4ru-story.htmlPublications for non-academic audiences
2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
Skydel J, Ross J, Ramachandran R. Accelerated approval: unfulfilled promises for FDA’s expedited review program. The Hill. 05/27/2022. https://thehill.com/blogs/congress-blog/3504591-accelerated-approval-unfulfilled-promises-for-fdas-expedited-review-program/Publications for non-academic audiencesAgreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study
Moneer O, Daly G, Skydel JJ, Nyhan K, Lurie P, Ross JS, Wallach JD. Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study. The BMJ 2022, 377: e069400. PMID: 35537738, PMCID: PMC9086409, DOI: 10.1136/bmj-2021-069400.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsCOVID-19 treatmentObservational studyMeta-epidemiological studyEfficacy outcomesLopinavir-ritonavirLiving reviewTreatment effectsCOVID-19 treatment guidelinesSame interventionCOVID-19Continuous outcomesMeta-analyze evidenceTrial sequential analysisSummary treatment effectsDistribution of sexTreatment guidelinesIndividual RCTsSelection of studiesEvidence DatabasePlacebo comparatorClinical dataStudy demographicsRCTsDichotomous outcomesTherapeutic interventionsSpending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial results
2021
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, Ross JS. Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. JAMA Network Open 2021, 4: e2133667. PMID: 34751763, PMCID: PMC8579227, DOI: 10.1001/jamanetworkopen.2021.33667.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsUS Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approvalReporting 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 ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsNovel 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 samplePatientsCharacteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019
Elliott MH, Skydel JJ, Dhruva SS, Ross JS, Wallach JD. Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019. JAMA Internal Medicine 2021, 181: 282-284. PMID: 33226398, PMCID: PMC7684521, DOI: 10.1001/jamainternmed.2020.4799.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and Concepts
Academic Achievements & Community Involvement
activity Heterogeneous neutrophil subsets infiltrate glomeruli of lupus nephritis patients and are elevated in the kidneys and urine of sunlight-induced nephritis flares
Poster PresentationACR Convergence 2024Details11/18/2024 - PresentWashington, DC, United StatesCollaborators- Noelle KosarekGeisel School of Medicine at Dartmouth
- Joshua J. Skydel, MD
- Alecia RoyDartmouth College
- Fred KollingGeisel School of Medicine at Dartmouth
- Lucas SalasGeisel School of Medicine at Dartmouth
- Christopher BurnsDartmouth Hitchcock Medical Center
- Andrea FavaJohns Hopkins University
- Sladjana Skopelja-GardnerGeisel School of Medicine at Dartmouth
activity Geographic and demographic representation in industry-sponsored, US-based clinical trials of systemic lupus erythematosus therapies
Oral PresentationACR Convergence 2023Details11/13/2023 - PresentSan Diego, CA, United StatesCollaborators- Joshua J. Skydel, MD
- Reshma Ramachandran, MD, MPP, MHS
- Sakinah Carter Suttiratana, PhD, MPH, MBA
- Joseph Ross, MD, MHS
- Joshua Wallach
- Christopher BurnsDartmouth Hitchcock Medical Center
activity Spatial transcriptomics reveals normal-density and low-density neutrophils are more prevalent than macrophages in lupus nephritis glomeruli, and urine DNA methylation analyses capture both myeloid populations
Poster PresentationACR Convergence 2023Details11/13/2023 - PresentSan Diego, CA, United StatesCollaborators- Sladjana Skopelja-GardnerGeisel School of Medicine at Dartmouth
- Joshua J. Skydel, MD
- Alecia RoyDartmouth College
- Brenna KerinGeisel School of Medicine at Dartmouth
- James WhitleyGeisel School of Medicine at Dartmouth
- Fred KollingGeisel School of Medicine at Dartmouth
- Noelle KosarekGeisel School of Medicine at Dartmouth
- Michelle PetriJohns Hopkins University
- Andrea FavaJohns Hopkins University
- Lucas SalaGeisel School of Medicine at Dartmouth
- Christopher BurnsDartmouth Hitchcock Medical Center
activity Exploring the clinical characteristics and correlation with corticosteroid dependence in polymyalgia rheumatica (PMR) patients: insights from an academic center
Poster PresentationACR Convergence 2023Details11/13/2023 - PresentSan Diego, CA, United StatesCollaborators- William RigbyDartmouth Hitchcock Medical Center
- Todd MackenzieDartmouth College
- Emily CampbellDartmouth Hitchcock Medical Center
- Joshua J. Skydel, MD
- Bryan SavageDartmouth Hitchcock Medical Center
- Monica DimambroDartmouth College
- Vivekanand TiwariDartmouth Hitchcock Medical Center
honor Student and Resident Research Award
National AwardRheumatology Research FoundationDetails10/01/2023United States