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Audrey D. Zhang
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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
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
822020
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
812020
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
292021
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
262021
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
232021
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
202021
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
202019
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
172021
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
112021
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
72019
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
62020
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
52023
Comparison of industry payments to physicians and advanced practice clinicians
AD Zhang, TS Anderson
jama 328 (24), 2452-2455, 2022
52022
Biomarkers as surrogate endpoints: ongoing opportunities for validation
AD Zhang, JS Ross
The Journal of Law, Medicine & Ethics 47 (3), 393-395, 2019
32019
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
22021
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
22021
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
12023
Demographic characteristics of participants in clinical trials to treat Alzheimer disease, 2008–2023
AD Zhang, TS Anderson, SN Hastings
Journal of the American Geriatrics Society 72 (3), 942-945, 2024
2024
INCLUSION AND EXCLUSION CRITERIA IN INDUSTRY-SPONSORED CLINICAL TRIALS OF DRUGS FOR TYPE 2 DIABETES, 2006-2015
AD Zhang, JD Wallach, JS Ross
JOURNAL OF GENERAL INTERNAL MEDICINE 35 (SUPPL 1), S173-S174, 2020
2020
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