Audrey Zhang

Duke University Medical Center | DUMC

This cross-sectional study examines the recommendations and agency actions of temporary and permanent US Food and Drug Administration advisory committee members from 2017 to 2021.

The impact and effectiveness of clinical trial data sharing initiatives may differ depending on the data sharing model used. We characterized outcomes associated with models previously used by the U.S. National Institutes of Health (NIH): National Heart, Lung, and Blood Institute’s (NHLBI) centralized model and National Cancer Institute’s (NCI) dec...

Objective This study examined the extent to which trials presented at major international medical conferences in 2016 consistently reported their study design, end points and results across conference abstracts, published article abstracts and press releases. Design Cross-sectional analysis of clinical trials presented at 12 major medical conferen...

This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018.

Background: The impact and value of clinical trial data sharing, including the number and quality of publications that result from shared data — shared data publications — may differ depending on the data sharing model used. Methods: We characterized the outcomes associated with two data sharing models previously used by Institutes of the U.S. Nati...

Importance After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional clinical data to obtain supplemental approval for use for new indications. Objective To characterize pivotal trials supporting recent supplemental new indication approvals of drugs and biologics by the FDA and to compare them with pivotal...

Importance: Chiral switching, a strategy in which drug manufacturers develop a single-enantiomer formulation of a drug to be substituted for a racemic formulation, allows manufacturers to maintain market exclusivity for drugs losing patent protection, even without demonstrating superior efficacy or safety. Objective: To identify and characterize...

Importance Adequate representation of demographic subgroups in premarketing and postmarketing clinical studies is necessary for understanding the safety and efficacy associated with novel cancer therapeutics. Objective To characterize and compare the reporting of demographic data and the representation of individuals by sex, age, and race in prema...

Background/aims: The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics ("therapeutics"). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our und...

This cross-sectional study evaluates all of the novel vaccines approved by the US Food and Drug Administration over the last decade.

Background/Aims: The U.S. Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics ("therapeutics"). As regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, postmarketing studies are intended to advan...

This cross-sectional study examines the frequency of disagreements within the US Food and Drug Administration (FDA) regarding approval of novel therapeutic agents.

Importance Since the introduction of the Fast Track designation in 1988, the number of special regulatory programs available for the approval of new drugs and biologics by the US Food and Drug Administration (FDA) has increased, offering the agency flexibility with respect to evidentiary requirements. Objective To characterize pivotal efficacy tri...

Objectives To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approache...

Objective: To evaluate whether characteristics of pivotal efficacy trials supporting US Food and Drug Administration (FDA) approval of novel therapeutic agents have changed over the past three decades. Design: Cross-sectional study. Setting and population: Publicly available data on novel therapeutics approved by the FDA between 1995-1997, 2005-200...

Surrogate endpoints are a common application of biomarkers to estimate clinical benefit in clinical trials, despite questions about reliability. This article discusses ongoing opportunities for their validation, in the context of a regulatory environment in which they are increasingly championed.

Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory commit...

Between 2011 and 2015, the Food and Drug Administration (FDA) approved 170 new therapeutic agents, and the European Medicines Agency (EMA) approved 144. The times for those regulatory reviews were, on average, 60 days shorter at the FDA than at the EMA.