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Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies.
- Published in:
- JAMA Network Open, 2024, v. 7, n. 8, p. e2430486, doi. 10.1001/jamanetworkopen.2024.30486
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- Publication type:
- Article
Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study.
- Published in:
- BMC Medical Research Methodology, 2024, v. 24, n. 1, p. 1, doi. 10.1186/s12874-024-02307-1
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- Publication type:
- Article
Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.
- Published in:
- JAMA Health Forum, 2022, v. 3, n. 5, p. e221158, doi. 10.1001/jamahealthforum.2022.1158
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- Publication type:
- Article
Reproducible research practices, transparency, and open access data in the biomedical literature, 2015–2017.
- Published in:
- PLoS Biology, 2018, v. 16, n. 11, p. 1, doi. 10.1371/journal.pbio.2006930
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- Publication type:
- Article
Altmetric Attention Scores and Citations of Published Research With or Without Preprints.
- Published in:
- JAMA Network Open, 2024, v. 7, n. 7, p. e2424732, doi. 10.1001/jamanetworkopen.2024.24732
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- Publication type:
- Article
Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.
- Published in:
- JAMA Network Open, 2024, v. 7, n. 4, p. e249233, doi. 10.1001/jamanetworkopen.2024.9233
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- Publication type:
- Article
Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics.
- Published in:
- JAMA Network Open, 2023, v. 6, n. 8, p. e2331753, doi. 10.1001/jamanetworkopen.2023.31753
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- Publication type:
- Article
Characteristics of Registered Clinical Trials Evaluating the Role of e-Cigarettes in Cessation or Reduction of Cigarette Smoking.
- Published in:
- 2021
- By:
- Publication type:
- letter
Characteristics of Ongoing Clinical Trials for Alcohol Use Disorder Registered on ClinicalTrials.gov.
- Published in:
- 2020
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- Publication type:
- journal article
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials.
- Published in:
- Clinical Trials, 2023, v. 20, n. 6, p. 689, doi. 10.1177/17407745231193137
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- Publication type:
- Article
Characteristics of available studies and dissemination of research using major clinical data sharing platforms.
- Published in:
- Clinical Trials, 2021, v. 18, n. 6, p. 657, doi. 10.1177/17407745211038524
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- Publication type:
- Article
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018.
- Published in:
- Clinical Trials, 2021, v. 18, n. 4, p. 488, doi. 10.1177/17407745211005044
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- Publication type:
- Article
Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews.
- Published in:
- 2020
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- Publication type:
- Letter
The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation.
- Published in:
- Clinical Trials, 2018, v. 15, n. 3, p. 243, doi. 10.1177/1740774518770657
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- Publication type:
- Article
The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.
- Published in:
- Clinical Trials, 2018, v. 15, n. 3, p. 219, doi. 10.1177/1740774518770648
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- Publication type:
- Article
Breakthrough Therapy Designation for New Drugs-Reply.
- Published in:
- 2018
- By:
- Publication type:
- Letter to the Editor
Off-label Use of Medications-Reply.
- Published in:
- 2018
- By:
- Publication type:
- letter
Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation.
- Published in:
- 2018
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- Publication type:
- journal article
Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts.
- Published in:
- 2018
- By:
- Publication type:
- editorial
Adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals.
- Published in:
- 2018
- By:
- Publication type:
- journal article
Assessment of transparency indicators across the biomedical literature: How open is open?
- Published in:
- PLoS Biology, 2021, v. 19, n. 3, p. 1, doi. 10.1371/journal.pbio.3001107
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- Publication type:
- Article
Evaluation of confounding in epidemiologic studies assessing alcohol consumption on the risk of ischemic heart disease.
- Published in:
- 2020
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- Publication type:
- journal article
Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
- Published in:
- JAMA Network Open, 2019, v. 2, n. 5, p. e193410, doi. 10.1001/jamanetworkopen.2019.3410
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- Publication type:
- Article
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.
- Published in:
- Journal of Law, Medicine & Ethics, 2021, v. 49, n. 3, p. 456, doi. 10.1017/jme.2021.67
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- Publication type:
- Article
Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015.
- Published in:
- JAMA Network Open, 2020, v. 3, n. 7, p. e209498, doi. 10.1001/jamanetworkopen.2020.9498
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- Publication type:
- Article
Assessment of Preprint Policies of Top-Ranked Clinical Journals.
- Published in:
- JAMA Network Open, 2020, v. 3, n. 7, p. e2011127, doi. 10.1001/jamanetworkopen.2020.11127
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- Publication type:
- Article
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.
- Published in:
- JAMA: Journal of the American Medical Association, 2024, v. 332, n. 19, p. 1646, doi. 10.1001/jama.2024.4175
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- Publication type:
- Article
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics.
- Published in:
- JAMA: Journal of the American Medical Association, 2023, v. 330, n. 24, p. 2392, doi. 10.1001/jama.2023.21958
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- Publication type:
- Article
Conflicts of Interest Among Authors of Published Cannabidiol Articles, 2014-2019.
- Published in:
- 2020
- By:
- Publication type:
- letter
Conflicts of Interest Among Authors of Published Cannabidiol Articles, 2014–2019.
- Published in:
- Annals of Internal Medicine, 2020, v. 172, n. 11, p. 769, doi. 10.7326/M19-3650
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- Publication type:
- Article
Medicare Part D Spending on Single-Enantiomer Drugs Versus Their Racemic Precursors.
- Published in:
- 2019
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- Publication type:
- journal article
Not Reporting Results of a Clinical Trial Is Academic Misconduct.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Systematic overview of Freedom of Information Act requests to the Department of Health and Human Services from 2008 to 2017.
- Published in:
- Research Integrity & Peer Review, 2019, v. 4, n. 1, p. N.PAG, doi. 10.1186/s41073-019-0086-2
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- Publication type:
- Article
Vibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk.
- Published in:
- 2020
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- Publication type:
- journal article
Commentary: The challenge of evaluating and improving evidence when research lacks reproducibility.
- Published in:
- 2016
- By:
- Publication type:
- journal article
Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies.
- Published in:
- Journal of Rheumatology, 2024, v. 51, n. 3, p. 320, doi. 10.3899/jrheum.2023-0920
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- Publication type:
- Article
U.S. Prescribing of On-and-Off-Label Medications for Alcohol Use Disorder in Outpatient Visits: NAMCS 2014 to 2016.
- Published in:
- 2022
- By:
- Publication type:
- Letter
Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
- Published in:
- 2021
- By:
- Publication type:
- Letter
Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies.
- Published in:
- 2019
- By:
- Publication type:
- letter
Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Evidence of subgroup differences in meta‐analyses evaluating medications for alcohol use disorder: An umbrella review.
- Published in:
- Alcohol: Clinical & Experimental Research, 2024, v. 48, n. 1, p. 5, doi. 10.1111/acer.15229
- By:
- Publication type:
- Article
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 11, p. e2133667, doi. 10.1001/jamanetworkopen.2021.33667
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- Publication type:
- Article
Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 11, p. e2133601, doi. 10.1001/jamanetworkopen.2021.33601
- By:
- Publication type:
- Article
Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 10, p. e2130587, doi. 10.1001/jamanetworkopen.2021.30587
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- Publication type:
- Article
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 5, p. e215731, doi. 10.1001/jamanetworkopen.2021.5731
- By:
- Publication type:
- Article
Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 5, p. e217075, doi. 10.1001/jamanetworkopen.2021.7075
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- Publication type:
- Article
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 4, p. e217063, doi. 10.1001/jamanetworkopen.2021.7063
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- Publication type:
- Article
Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals.
- Published in:
- JAMA Network Open, 2021, v. 4, n. 3, p. e212110, doi. 10.1001/jamanetworkopen.2021.2110
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- Publication type:
- Article
Characterizing Patient-Centered Postoperative Recovery After Adult Cardiac Surgery: A Systematic Review.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.
- Published in:
- 2018
- By:
- Publication type:
- journal article