David Martin

发表

Sequential surveillance for drug safety in a regulatory environment

Susan Gruber, J. Gagne, S. Schneeweiss, 2018, Pharmacoepidemiology and drug safety.

Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting

Lin Wang, Adrian F Hernandez, Jesse A Berlin, 2020, Therapeutic Innovation & Regulatory Science.

FDA-Catalyst—Using FDA’s Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial

Vinit Nair, Richard Platt, Kevin Haynes, 2018, Clinical trials.

Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial

C. Granger, R. Platt, N. Cocoros, 2020, Clinical Trials.

Evaluating the Use of Nonrandomized Real‐World Data Analyses for Regulatory Decision Making

David Martin, Sebastian Schneeweiss, Jessica M Franklin, 2019, Clinical pharmacology and therapeutics.

Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation

Jonathan W. Inselman, P. Noseworthy, N. Desai, 2020, Circulation. Cardiovascular quality and outcomes.

Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).

Vinit Nair, Richard Platt, Kevin Haynes, 2020, American heart journal.

Using Real-World Data to Predict Findings of an Ongoing Phase IV Cardiovascular Outcome Trial: Cardiovascular Safety of Linagliptin Versus Glimepiride

S. Schneeweiss, J. Franklin, C. Gopalakrishnan, 2019, Diabetes Care.

Recommendations for patient similarity classes: results of the AMIA 2019 workshop on defining patient similarity

Gil Alterovitz, Matvey B Palchuk, Feichen Shen, 2020, J. Am. Medical Informatics Assoc..

Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative.

S. Schneeweiss, R. Glynn, R. Desai, 2020, Circulation.

Nonrandomized Real‐World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project

Mark S Levenson, S. Schneeweiss, R. Glynn, 2020, Clinical pharmacology and therapeutics.

A causal roadmap for generating high-quality real-world evidence

Raymond A. Huml, E. Stuart, Emre Kıcıman, 2023, Journal of Clinical and Translational Science.

Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials.

J. Concato, S. Schneeweiss, R. Glynn, 2023, JAMA.

Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions

Robert W. Platt, James R. Rogers, T. Brennan, 2022, Nature Communications.

Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

Richard Platt, David Martin, Jeffrey S Brown, 2020, Journal of the American Society of Nephrology : JASN.

Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug–outcome association

Sengwee Toh, Susan Gruber, Mark Levenson, 2016, Pharmacoepidemiology and drug safety.