Scholars@Duke

• Publications & Artistic Works
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  Selected Publications

  • Academic Articles

    • Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang AD, Wallach JD, et al. Consistency between trials presented at conferences, their subsequent publications and press releases. Bmj Evidence Based Medicine. 2023 Apr;28(2):95–102.
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    • Zhang AD, Anderson TS. Comparison of Industry Payments to Physicians and Advanced Practice Clinicians. Jama. 2022 Dec;328(24):2452–5.
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    • Zhang AD, Puthumana J, Egilman AC, Schwartz JL, Ross JS. Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020. Journal of General Internal Medicine. 2022 Feb;37(3):700–2.
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    • Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, et al. 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 Nov;4(11):e2133667.
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    • Egilman A, Wallach JD, Puthumana J, Zhang AD, Schwartz JL, Ross JS. Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration. Journal of General Internal Medicine. 2021 Oct;36(10):3281–4.
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    • 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 (London, England). 2021 Aug;18(4):488–99.
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    • Dhodapkar M, Zhang AD, Puthumana J, Downing NS, Shah ND, Ross JS. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019. Jama Network Open. 2021 Jun;4(6):e2113224.
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    • Long AS, Zhang AD, Meyer CE, Egilman AC, Ross JS, Wallach JD. Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review. Jama Network Open. 2021 May;4(5):e215731.
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    • Puthumana J, Egilman AC, Zhang AD, Schwartz JL, Ross JS. Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration. Jama Internal Medicine. 2021 Apr;181(4):559–60.
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    • Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, et al. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. Jama Netw Open. 2021 Apr 1;4(4):e217063.
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    • MacGregor A, Zhang AD, Wallach JD, Ross JS, Herder M. Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015. Jama Network Open. 2020 Jul;3(7):e209498.
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    • Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. Jama Network Open. 2020 Apr;3(4):e203284.
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    • Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, et al. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. Bmj (Clinical Research Ed). 2020 Feb;368:l7078.
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    • Egilman AC, Zhang AD, Wallach JD, Ross JS. Medicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors. Annals of Internal Medicine. 2019 Oct;171(7):521–3.
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    • Zhang AD, Ross JS. Biomarkers as Surrogate Endpoints: Ongoing Opportunities for Validation. The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics. 2019 Sep;47(3):393–5.
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    • Zhang AD, Schwartz JL, Ross JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. The Milbank Quarterly. 2019 Sep;97(3):796–819.
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    • Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents. The New England Journal of Medicine. 2017 Jun;376(26):2598.
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    • Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015. The New England Journal of Medicine. 2017 Apr;376(14):1386–7.
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  • Preprints

    • Rowhani-Farid A, Egilman AC, Zhang AD, Gross CP, Krumholz HM, Ross JS. Clinical Trial Data Sharing: A Cross-Sectional Study of Outcomes Associated with Two NIH Models. Cold Spring Harbor Laboratory. 2021.
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    • Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. U.S. Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018. Cold Spring Harbor Laboratory. 2020.
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    • Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents Over Three Decades, 1995-2017: Cross-Sectional Analysis. Cold Spring Harbor Laboratory. 2019.
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    • Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, et al. Updating Insights into Rosiglitazone and Cardiovascular Risk through Shared Data: Individual Patient- and Summary-Level Meta-Analyses. Cold Spring Harbor Laboratory. 2019.
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