Publications by authors named "Mark Levenson"

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US Food and Drug Administration's Advancing Real-World Evidence Program: Initial Experience.
Kimberly A Smith, Yin Huang, Theresa Kehoe, Stefanie Kraus, Mark Levenson

Clin Pharmacol Ther· September 2025

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Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration-National Institutes of Health Collaboration.
Donna R Rivera, Tracy L Cutler, Lisa McShane, Ann Meeker-O'Connell, Hilary D Marston, Mark Levenson

JAMA Netw Open· June 2025

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When can real-world data generate real-world evidence?
Motiur Rahman, Gerald Dal Pan, Peter Stein, Mark Levenson, Stefanie Kraus

Pharmacoepidemiol Drug Saf· January 2024

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Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.
Sean D Pokorney, Noelle Cocoros, Hussein R Al-Khalidi, Kevin Haynes, Shuang Li, Mark Levenson

JAMA Netw Open· May 2022

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Regulatory-grade clinical trial design using real-world data.
Mark S Levenson

Clin Trials· August 2020

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University of Pennsylvania 12th annual conference on statistical issues in clinical trials: Electronic health records in randomized clinical trials-challenges and opportunities (morning panel session).
Denise Esserman, Benjamin A Goldstein, Mark Levenson, Richard Platt, Matthew T Roe

Clin Trials· August 2020

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Comment on "Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic".
Sylva H Collins, Mark S Levenson

Stat Biopharm Res· July 2020

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Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project.
Jessica M Franklin, Ajinkya Pawar, David Martin, Robert J Glynn, Mark Levenson

Clin Pharmacol Ther· April 2020

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The impact of FDA regulatory activities on incident dispensing of LABA-containing medication: 2005-2011.
Meghan A Baker, Melissa G Butler, Sally Seymour, Fang Zhang, Yute Wu, Mark S Levenson

J Asthma· August 2018

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Important statistical considerations in the evaluation of post-market studies to assess whether opioids with abuse-deterrent properties result in reduced abuse in the community.
Kunthel By, Jana K McAninch, Stephine L Keeton, Alex Secora, Cynthia J Kornegay, Mark S Levenson

Pharmacoepidemiol Drug Saf· May 2018

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Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights.
Olga Marchenko, Estelle Russek-Cohen, Mark Levenson, Richard C Zink, Michelle R Krukas-Hampel

Ther Innov Regul Sci· March 2018

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Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare.
Cunlin Wang, Robert Kane, Mark Levenson, Jeffrey Kelman, Michael Wernecke

JAMA Intern Med· December 2016

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Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.
Simone P Pinheiro, Donna R Rivera, David J Graham, Andrew N Freedman, Jacqueline M Major, Mark Levenson

Ann Epidemiol· November 2016

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The role of quantitative safety evaluation in regulatory decision making of drugs.
Aloka G Chakravarty, Rima Izem, Stephine Keeton, Clara Y Kim, Mark S Levenson

J Biopharm Stat· October 2016

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Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database.
Katrina Mott, David J Graham, Sengwee Toh, Joshua J Gagne, Mark Levenson

Pharmacoepidemiol Drug Saf· September 2016

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Strategies addressing inadequate information on health factors in pharmacoepidemiology studies relying on healthcare databases: commentary from a public workshop.
Efe Eworuke, Fadia Shaya, David J Graham, Jacqueline Major, Mark Levenson

Pharmacoepidemiol Drug Saf· September 2016

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Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association.
Susan Gruber, Aloka Chakravarty, Susan R Heckbert, Mark Levenson, David Martin

Pharmacoepidemiol Drug Saf· September 2016

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Changing patterns of asthma medication use related to US Food and Drug Administration long-acting β2-agonist regulation from 2005-2011.
Melissa G Butler, Esther H Zhou, Fang Zhang, Yu-te Wu, Ann Chen Wu, Mark S Levenson

J Allergy Clin Immunol· March 2016

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Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products.
Cunlin Wang, David J Graham, Robert C Kane, Diqiong Xie, Michael Wernecke, Mark Levenson

JAMA· November 2015

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Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation.
David J Graham, Marsha E Reichman, Michael Wernecke, Rongmei Zhang, Mary Ross Southworth, Mark Levenson

Circulation· January 2015

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Round window reinforcement for superior semicircular canal dehiscence: a retrospective multi-center case series.
Herbert Silverstein, Jack M Kartush, Lorne S Parnes, Dennis S Poe, Seilesh C Babu, Mark J Levenson

Am J Otolaryngol· December 2014

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Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study.
David J Graham, Kunthel By, Stephen McKean, Andrew Mosholder, Cynthia Kornegay, Mark Levenson

Pharmacoepidemiol Drug Saf· November 2014

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Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems.
Carlos Bell, Aloka Chakravarty, Susan Gruber, Susan R Heckbert, Mark Levenson

Pharmacoepidemiol Drug Saf· November 2014

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Drug risk assessment and data reuse.
Solomon Iyasu, Judy Staffa, Dave Graham, Azadeh Shoaibi, Mark Levenson

Pharmacoepidemiol Drug Saf· January 2014

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