Cargando…

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis

IMPORTANCE: Noninferiority trials test whether a new intervention is not worse than the comparator by a given margin. OBJECTIVES: To study the characteristics of published randomized noninferiority trials in oncology with overall survival as an end point, to assess the association of justification a...

Descripción completa

Detalles Bibliográficos
Autores principales:	Gyawali, Bishal, Tessema, Frazer A., Jung, Emily H., Kesselheim, Aaron S.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2019
Materias:	Original Investigation
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724156/ https://www.ncbi.nlm.nih.gov/pubmed/31469391 http://dx.doi.org/10.1001/jamanetworkopen.2019.9570

Ejemplares similares

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)

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

Public funding for transformative drugs: the case of sofosbuvir
por: Barenie, Rachel E., et al.
Publicado: (2021)

Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis
por: Addeo, Alfredo, et al.
Publicado: (2019)

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

Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
por: Gyawali, Bishal, et al.
Publicado: (2021)

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)

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)

What Global Oncology Needs: Mutual Learning and More Funding
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)

Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma: A Randomized Clinical Trial
por: Pope, Elena, et al.
Publicado: (2021)

In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial
por: Burzynski, Joseph, et al.
Publicado: (2022)

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review
por: Ito, Chiyo, et al.
Publicado: (2021)

Satisfaction with modes of telemedicine delivery during COVID-19: A randomized, single-blind, parallel group, noninferiority trial
por: Danila, Maria I., et al.
Publicado: (2022)

Variations in Use of Diabetes Drugs With Cardiovascular Benefits Among Medicaid Patients
por: Zhai, Mike Z., et al.
Publicado: (2022)

Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021
por: Daval, C. Joseph Ross, et al.
Publicado: (2023)

Effectiveness of a Female Community Health Volunteer–Delivered Intervention in Reducing Blood Glucose Among Adults With Type 2 Diabetes: An Open-Label, Cluster Randomized Clinical Trial
por: Gyawali, Bishal, et al.
Publicado: (2021)

Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial
por: Liu, Yongjun, et al.
Publicado: (2023)

Cognitive success: instrumental justifications of normative systems of reasoning
por: Schurz, Gerhard
Publicado: (2014)

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

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

Effect of Intermittent Compared With Continuous Energy Restricted Diet on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Noninferiority Trial
por: Carter, Sharayah, et al.
Publicado: (2018)

Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial
por: Yamada, Suguru, et al.
Publicado: (2021)

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

Outcomes of the 340B Drug Pricing Program: A Scoping Review
por: Knox, Ryan P., et al.
Publicado: (2023)

Defining the noninferiority margin and analysing noninferiority: An overview
por: Althunian, Turki A., et al.
Publicado: (2017)

Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison
por: Mack, V., et al.
Publicado: (2020)

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer
por: Raphael, Michael J., et al.
Publicado: (2021)

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)

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial
por: Ortblad, Katrina F., et al.
Publicado: (2023)

The justification of induction
Publicado: (1974)

Knowledge and justification /
Publicado: (1994)

Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019
por: Clemans-Cope, Lisa, et al.
Publicado: (2023)

Placebo vs Amoxicillin for Nonsevere Fast-Breathing Pneumonia in Malawian Children Aged 2 to 59 Months: A Double-blind, Randomized Clinical Noninferiority Trial
por: Ginsburg, Amy Sarah, et al.
Publicado: (2018)

Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial
por: Thornton, Christina S., et al.
Publicado: (2020)

Heterogeneity of antidiabetic treatment effect on the risk of major adverse cardiovascular events in type 2 diabetes: a systematic review and meta-analysis
por: D’Andrea, Elvira, et al.
Publicado: (2020)

Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015
por: Khorrami, Peggah, et al.
Publicado: (2022)

Noninferiority trials
por: Snapinn, Steven M
Publicado: (2000)

Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial
por: Aspvall, Kristina, et al.
Publicado: (2019)

Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome: The H-REPLACE Randomized Equivalence and Noninferiority Trial
por: Zhou, Shenghua, et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_o1mh6tqpfges4c4kuh8hmanvam