Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015

por MacGregor, Andrea, Zhang, Audrey D., Wallach, Joshua D., Ross, Joseph S., Herder, Matthew
Publicado 2020

Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020

por Zhang, Audrey D., Puthumana, Jeremy, Egilman, Alexander C., Schwartz, Jason L., Ross, Joseph S.
Publicado 2021

Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019

por Dhodapkar, Meera, Zhang, Audrey D., Puthumana, Jeremy, Downing, Nicholas S., Shah, Nilay D., Ross, Joseph S.
Publicado 2021

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

por Zhang, Audrey D., Puthumana, Jeremy, Downing, Nicholas S., Shah, Nilay D., Krumholz, Harlan M., Ross, Joseph S.
Publicado 2020

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration

por Egilman, Alexander, Wallach, Joshua D., Puthumana, Jeremy, Zhang, Audrey D., Schwartz, Jason L., Ross, Joseph S.
Publicado 2021

Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review

por Long, Aaron S., Zhang, Audrey D., Meyer, Caitlin E., Egilman, Alexander C., Ross, Joseph S., Wallach, Joshua D.
Publicado 2021

Consistency between trials presented at conferences, their subsequent publications and press releases

por Rowhani-Farid, Anisa, Hong, Kyungwan, Grewal, Mikas, Reynolds, Jesse, Zhang, Audrey D, Wallach, Joshua D, Ross, Joseph S
Publicado 2023

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval

por Wallach, Joshua D., Zhang, Audrey D., Skydel, Joshua J., Bartlett, Victoria L., Dhruva, Sanket S., Shah, Nilay D., Ross, Joseph S.
Publicado 2021

Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models

por Rowhani-Farid, Anisa, Grewal, Mikas, Solar, Steven, Eghrari, Allen O., Zhang, Audrey D., Gross, Cary P., Krumholz, Harlan M., Ross, Joseph S.
Publicado 2023

Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics

por Varma, Tanvee, Wallach, Joshua D., Miller, Jennifer E., Schnabel, Dominic, Skydel, Joshua J., Zhang, Audrey D., Dinan, Michaela A., Ross, Joseph S., Gross, Cary P.
Publicado 2021

Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses

por Wallach, Joshua D, Wang, Kun, Zhang, Audrey D, Cheng, Deanna, Grossetta Nardini, Holly K, Lin, Haiqun, Bracken, Michael B, Desai, Mayur, Krumholz, Harlan M, Ross, Joseph S
Publicado 2020