Assessment of clinical trials supporting US Food and Drug Administration approval of novel therapeutic agents, 1995-2017 AD Zhang, J Puthumana, NS Downing, ND Shah, HM Krumholz, JS Ross JAMA Network Open 3 (4), e203284-e203284, 2020 | 100 | 2020 |
Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses JD Wallach, K Wang, AD Zhang, D Cheng, HKG Nardini, H Lin, ... bmj 368, 2020 | 97* | 2020 |
Regulatory review of new therapeutic agents—FDA versus EMA, 2011–2015 NS Downing, AD Zhang, JS Ross New England Journal of Medicine 376 (14), 1386-1387, 2017 | 87 | 2017 |
Reporting of study participant demographic characteristics and demographic representation in premarketing and postmarketing studies of novel cancer therapeutics T Varma, JD Wallach, JE Miller, D Schnabel, JJ Skydel, AD Zhang, ... JAMA Network Open 4 (4), e217063-e217063, 2021 | 41 | 2021 |
Speed, evidence, and safety characteristics of vaccine approvals by the US Food and Drug Administration J Puthumana, AC Egilman, AD Zhang, JL Schwartz, JS Ross JAMA Internal Medicine 181 (4), 559-560, 2021 | 29 | 2021 |
Characteristics of clinical studies used for US Food and Drug Administration supplemental indication approvals of drugs and biologics, 2017 to 2019 M Dhodapkar, AD Zhang, J Puthumana, NS Downing, ND Shah, JS Ross JAMA Network Open 4 (6), e2113224-e2113224, 2021 | 27 | 2021 |
Association between Food and Drug Administration advisory committee recommendations and agency actions, 2008–2015 AD Zhang, JL Schwartz, JS Ross The Milbank Quarterly 97 (3), 796-819, 2019 | 25 | 2019 |
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018 JJ Skydel, AD Zhang, SS Dhruva, JS Ross, JD Wallach Clinical Trials 18 (4), 488-499, 2021 | 22 | 2021 |
Feasibility of using real-world data to emulate postapproval confirmatory clinical trials of therapeutic agents granted US Food and Drug Administration accelerated approval JD Wallach, AD Zhang, JJ Skydel, VL Bartlett, SS Dhruva, ND Shah, ... JAMA Network Open 4 (11), e2133667-e2133667, 2021 | 21 | 2021 |
Evaluation of trials comparing single-enantiomer drugs to their racemic precursors: A systematic review AS Long, AD Zhang, CE Meyer, AC Egilman, JS Ross, JD Wallach JAMA Network Open 4 (5), e215731-e215731, 2021 | 16 | 2021 |
Comparison of industry payments to physicians and advanced practice clinicians AD Zhang, TS Anderson JAMA 328 (24), 2452-2455, 2022 | 10 | 2022 |
Medicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors AC Egilman, AD Zhang, JD Wallach, JS Ross Annals of Internal Medicine, 2019 | 7 | 2019 |
Consistency between trials presented at conferences, their subsequent publications and press releases A Rowhani-Farid, K Hong, M Grewal, J Reynolds, AD Zhang, JD Wallach, ... BMJ Evidence-Based Medicine 28 (2), 95-102, 2023 | 6 | 2023 |
Disagreements within the US Food and Drug Administration regarding approval of novel therapeutic agents, 2011-2015 A MacGregor, AD Zhang, JD Wallach, JS Ross, M Herder JAMA Network Open 3 (7), e209498-e209498, 2020 | 6 | 2020 |
Biomarkers as surrogate endpoints: ongoing opportunities for validation AD Zhang, JS Ross The Journal of Law, Medicine & Ethics 47 (3), 393-395, 2019 | 4 | 2019 |
Characteristics of preapproval and postapproval studies of vaccines granted accelerated approval by the US Food and Drug Administration A Egilman, JD Wallach, J Puthumana, AD Zhang, JL Schwartz, JS Ross Journal of General Internal Medicine 36 (10), 3281-3284, 2021 | 3 | 2021 |
Clinical trial data sharing: a cross-sectional study of outcomes associated with two US National Institutes of Health models A Rowhani-Farid, M Grewal, S Solar, AO Eghrari, AD Zhang, CP Gross, ... Scientific Data 10 (1), 529, 2023 | 2 | 2023 |
Demographic characteristics of participants in trials essential to US Food and Drug Administration vaccine approvals, 2010–2020 AD Zhang, J Puthumana, AC Egilman, JL Schwartz, JS Ross Journal of General Internal Medicine, 1-3, 2021 | 2 | 2021 |
Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021 N Chaudhry, AD Zhang, JL Schwartz, R Ramachandran, JS Ross JAMA Network Open 7 (10), e2436789, 2024 | | 2024 |
Initiation and Persistence of Antipsychotic Medications at Hospital Discharge Among Community-Dwelling Veterans with Dementia AD Zhang, L Zepel, S Woolson, KEM Miller, LJ Schleiden, ... The American Journal of Geriatric Psychiatry, 2024 | | 2024 |