Reshma Ramachandran, MD, MPP, MHS, not only believes in equitable access to healthcare and medical products but is a formidable force in advocating for it.
Reshma Ramachandran, MD, MPP, MHS
Assistant Professor of Medicine (General Medicine)Cards
About
Reshma Ramachandran is a primary care physician trained in family medicine and health services researcher. Her research focuses on developing evidence-driven strategies to ensure equitable access to meaningfully effective and safe health innovations in the United States and abroad.
Research
Publications
2024
Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program
Mooghali M, Dhruva S, Ross J, Ramachandran R. Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program. JAMA 2024, 332 PMID: 39535767, PMCID: PMC11561719, DOI: 10.1001/jama.2024.20493.Peer-Reviewed Original ResearchAt-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation?
Kadakia K, Ross J, Ramachandran R. At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? JAMA Internal Medicine 2024, 184: 1153-1155. PMID: 39133501, DOI: 10.1001/jamainternmed.2024.2883.Peer-Reviewed Original ResearchTemporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021
Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.Peer-Reviewed Original ResearchFeasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study
Janda G, Jeffery M, Ramachandran R, Ross J, Wallach J. Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study. BMC Medical Research Methodology 2024, 24: 187. PMID: 39198727, PMCID: PMC11351457, DOI: 10.1186/s12874-024-02307-1.Peer-Reviewed Original ResearchConceptsElectronic health record dataElectronic health recordsSubstance use disordersCross-sectional studyAdministrative claimsEligibility criteriaTrials evaluating treatmentPublic health systemClinical trialsIntroductionReal-world evidenceSafety of medical productsHealth recordsHealth systemReal-world dataTrial emulationPrimary end pointInsurance claimsPhase 2Placebo comparatorActive comparatorInterventionEligibilityEnd pointsTrialsSurrogate Markers and Clinical Outcomes—Reply
Wallach J, Ramachandran R, Ross J. Surrogate Markers and Clinical Outcomes—Reply. JAMA 2024, 332: 936-937. PMID: 39167385, DOI: 10.1001/jama.2024.14279.Peer-Reviewed Original ResearchPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyConsent Form Reporting on ClinicalTrials.Gov, 2013-2023
Axson S, Ramachandran R, Lisenby A, Giordano N. Consent Form Reporting on ClinicalTrials.Gov, 2013-2023. JAMA Network Open 2024, 7: e2418895. PMID: 38904965, PMCID: PMC11193120, DOI: 10.1001/jamanetworkopen.2024.18895.Peer-Reviewed Original ResearchHPR82 Assessment of Supporting Evidence and Postmarketing Requirements for Therapeutic Indications With Real-Time Oncology Drug Review, 2018-2023
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. HPR82 Assessment of Supporting Evidence and Postmarketing Requirements for Therapeutic Indications With Real-Time Oncology Drug Review, 2018-2023. Value In Health 2024, 27: s208. DOI: 10.1016/j.jval.2024.03.1151.Peer-Reviewed Original ResearchHPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates
Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. HPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates. Value In Health 2024, 27: s214. DOI: 10.1016/j.jval.2024.03.1178.Peer-Reviewed Original ResearchAssociations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug Administration
News
News
- November 16, 2024Source: The Washington Post
In RFK Jr., drugmakers face an antagonist with regulatory power
- July 06, 2024Source: MSN
Chevron doctrine ruling a 'gut-punch' for US health and environment – experts
- June 26, 2024
Yale CRRIT Researchers Examine Cancer Drug Guidelines and FDA Approvals
- June 13, 2024Source: Nature
Unease as US drug agency weighs its use of independent scientists