Selected Publications
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article
- Factors influencing central nervous system medication deprescribing and behavior change in hospitalized older adults.. Journal of the American Geriatrics Society. 72:2359-2371. 2024
- Demographic characteristics of participants in clinical trials to treat Alzheimer disease, 2008-2023.. Journal of the American Geriatrics Society. 72:942-945. 2023
- Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models.. Scientific data. 10:-. 2023
- Long-Term Prognosis of Patients With Coexisting Obesity and Malnutrition After Acute Myocardial Infarction: A Cohort Study.. Circulation. Cardiovascular quality and outcomes. 16:-. 2023
- Consistency between trials presented at conferences, their subsequent publications and press releases.. BMJ evidence-based medicine. 28:95-102. 2022
- Comparison of Industry Payments to Physicians and Advanced Practice Clinicians. JAMA. 2022
- 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. 4:-. 2021
- Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.. Journal of general internal medicine. 36:3281-3284. 2021
- Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.. JAMA network open. 4:-. 2021
- Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review.. JAMA network open. 4:-. 2021
- US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.. Clinical trials (London, England). 18:488-499. 2021
- Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics.. JAMA network open. 4:-. 2021
- Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020.. Journal of general internal medicine. 37:700-702. 2021
- Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration. JAMA Internal Medicine. 2021
- Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open. 2020
- Disagreements within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015. JAMA Network Open. 2020
- Updating insights into rosiglitazone and cardiovascular risk through shared data: Individual patient and summary level meta-analyses 2020
- Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015 2019
- Biomarkers as Surrogate Endpoints: Ongoing Opportunities for Validation 2019
- Medicare part D spending on single-enantiomer drugs versus their racemic precursors. Annals of Internal Medicine. 2019
- Regulatory review of new therapeutic agents - FDA versus EMA, 2011-2015. New England Journal of Medicine. 2017
- The authors reply. New England Journal of Medicine. 2017
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document
- Clinical trial data sharing: A cross-sectional study of outcomes associated with two NIH models. medRxiv. 2021
- U.S. Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018. medRxiv. 2020
- Clinical trial evidence supporting FDA approval of novel therapeutic agents over three decades, 1995-2017: Cross-sectional analysis. medRxiv. 2019
- Updating insights into rosiglitazone and cardiovascular risk through shared data: Individual patient- and summary-level meta-analyses. medRxiv. 2019