Related references
Note: Only part of the references are listed.Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
Peter Arlett et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)
The PRISMA 2020 statement: An updated guideline for reporting systematic reviews
Matthew J. Page et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2021)
Efficacy gap between phase II and subsequent phase III studies in oncology
Rick A. Vreman et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2020)
Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication?
Andrea Keyter et al.
FRONTIERS IN PHARMACOLOGY (2020)
Selection of Endpoints in Clinical Trials: Trends in European Marketing Authorization Practice in Oncological Indications
Anna Kordecka et al.
VALUE IN HEALTH (2019)
The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018
Catherine Schuster Bruce et al.
PLOS MEDICINE (2019)
Benefit-risk evaluation: the past, present and future
Juhaeri Juhaeri
THERAPEUTIC ADVANCES IN DRUG SAFETY (2019)
Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials
Ariadna Tibau et al.
JAMA ONCOLOGY (2018)
Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval
Huseyin Naci et al.
MILBANK QUARTERLY (2017)
Structured Benefit-Risk Assessment Across the Product Lifecycle: Practical Considerations
Meredith Y. Smith et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2017)
Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions
F. Pignatti et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
The Strength of Association Between Surrogate End Points and Survival in Oncology A Systematic Review of Trial-Level Meta-analyses
Vinay Prasad et al.
JAMA INTERNAL MEDICINE (2015)
Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals
Chul Kim et al.
JAMA INTERNAL MEDICINE (2015)
A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?
Stuart Walker et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2015)
VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS
Oriana Ciani et al.
INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE (2014)
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Nicholas S. Downing et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2014)
Poor correlation between progression-free and overall survival in modern clinical trials: Are composite endpoints the answer?
Eitan Amir et al.
EUROPEAN JOURNAL OF CANCER (2012)
Refining the Benefit-Risk Framework for the Assessment of Medicines: Valuing and Weighting Benefit and Risk Parameters
S. Walker et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer
Aaron S. Kesselheim et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2011)
Progression-Free Survival Is Simply a Measure of a Drug's Effect While Administered and Is Not a Surrogate for Overall Survival
Julia Wilkerson et al.
CANCER JOURNAL (2009)
Share Paper
