Cargando…

Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

OBJECTIVES: To investigate the regulatory handling of cancer drugs that were granted accelerated approval by the US Food and Drug Administration (FDA) but failed to improve the primary endpoint in post-approval trials and to evaluate the extent to which negative post-approval trials changed the reco...

Descripción completa

Detalles Bibliográficos
Autores principales:	Gyawali, Bishal, Rome, Benjamin N, Kesselheim, Aaron S
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group Ltd. 2021
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424519/ https://www.ncbi.nlm.nih.gov/pubmed/34497044 http://dx.doi.org/10.1136/bmj.n1959

Ejemplares similares

Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
por: Deshmukh, Anjali D., et al.
Publicado: (2023)

Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
por: Cherla, Avi, et al.
Publicado: (2021)

Medicare Spending on Drugs With Accelerated Approval, 2015-2019
por: Rome, Benjamin N., et al.
Publicado: (2021)

National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval
por: Cliff, Edward R. Scheffer, et al.
Publicado: (2023)

Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs
por: Gyawali, Bishal, et al.
Publicado: (2020)

The Vexing Voyage of Vasopressin: The Consequences of Granting Market Exclusivity to Unapproved Drugs
por: Bendicksen, Liam, et al.
Publicado: (2022)

Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007–2016
por: Hwang, Thomas J, et al.
Publicado: (2018)

Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs
por: Mitra-Majumdar, Mayookha, et al.
Publicado: (2022)

Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study
por: Mostaghim, Sana R, et al.
Publicado: (2017)

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis
por: Gyawali, Bishal, et al.
Publicado: (2019)

Challenges of globalization of cancer drug trials- recruitment in LMICs, approval in HICs
por: Gyawali, Bishal, et al.
Publicado: (2021)

A Comparison of Response Patterns for Progression-Free Survival and Overall Survival Following Treatment for Cancer With PD-1 Inhibitors: A Meta-analysis of Correlation and Differences in Effect Sizes
por: Gyawali, Bishal, et al.
Publicado: (2018)

Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration
por: Feldman, Daniel, et al.
Publicado: (2022)

A correlation analysis to assess event-free survival as a trial-level surrogate for overall survival in early breast cancer
por: Gyawali, Bishal, et al.
Publicado: (2021)

Getting the Right Evidence After Drug Approval
por: Vreman, Rick A., et al.
Publicado: (2020)

Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
por: Vokinger, Kerstin N., et al.
Publicado: (2022)

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
por: Jiao, Kuo, et al.
Publicado: (2019)

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., et al.
Publicado: (2021)

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review
por: Wang, Bo, et al.
Publicado: (2015)

Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective
por: Drozda, Katarzyna, et al.
Publicado: (2018)

Negative trials in ovarian cancer: is there such a thing as too much optimism?
por: Gyawali, Bishal, et al.
Publicado: (2016)

Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
por: Moneer, Osman, et al.
Publicado: (2021)

Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
por: Lemery, Steven, et al.
Publicado: (2022)

Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014
por: Cherla, Avi, et al.
Publicado: (2022)

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019
por: Olsen, Anders, et al.
Publicado: (2023)

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
por: Kesselheim, Aaron S, et al.
Publicado: (2015)

Correlation Between Changes in Brand-Name Drug Prices and Patient Out-of-Pocket Costs
por: Rome, Benjamin N., et al.
Publicado: (2021)

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
por: Hwang, Thomas J, et al.
Publicado: (2020)

A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study
por: Lexchin, Joel
Publicado: (2021)

Cancer drugs in LMICs: cheap but unaffordable
por: Gyawali, Bishal
Publicado: (2017)

Regulatory Solutions to the Problem of High Generic Drug Costs
por: Luo, Jing, et al.
Publicado: (2015)

Trends in Medicare Spending on Oral Drugs for Chronic Lymphocytic Leukemia From 2014 to 2020
por: Cliff, Edward R. Scheffer, et al.
Publicado: (2023)

Characteristics of US Patients and Prescribers Using Hydroxychloroquine During the COVID-19 Pandemic
por: Rome, Benjamin N., et al.
Publicado: (2021)

Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020
por: Mitra-Majumdar, Mayookha, et al.
Publicado: (2022)

Information about confirmatory studies required for new drugs conditionally approved by Health Canada: A cross-sectional study
por: Lexchin, Joel
Publicado: (2022)

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019
por: Lythgoe, Mark P., et al.
Publicado: (2022)

Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
por: Hwang, Thomas J., et al.
Publicado: (2022)

Monkeypox, smallpox, FDA, and accelerated approval of vaccines – A regulatory perspective
por: Sun, Wellington
Publicado: (2023)

Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
por: Kesselheim, Aaron S., et al.
Publicado: (2016)

Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
por: Naci, Huseyin, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_2ecilnfgjtko1g2vk75qf1fhs7