相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials
Emerson Y. Chen et al.
JAMA INTERNAL MEDICINE (2019)
Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration
Talal Hilal et al.
JAMA ONCOLOGY (2019)
New drugs: where did we go wrong and what can we do better?
Beate Wieseler et al.
BMJ-BRITISH MEDICAL JOURNAL (2019)
Options for publishing research without any P-values
John P. A. Ioannidis
EUROPEAN HEART JOURNAL (2019)
Expediting drug development for serious illness: Trade-offs between patient access and certainty
Janet Woodcock
CLINICAL TRIALS (2018)
Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial
James Larkin et al.
JOURNAL OF CLINICAL ONCOLOGY (2018)
Oncologic orphan drugs approved in the EU - do clinical trial data correspond with real-world effectiveness?
Yvonne Schuller et al.
ORPHANET JOURNAL OF RARE DISEASES (2018)
Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology A Systematic Review and Quantitative Analysis
Bruno Kovic et al.
JAMA INTERNAL MEDICINE (2018)
European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception?
Anne Vinther Morant et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2018)
Cancer drugs: high price, uncertain value
Deborah Cohen
BMJ-BRITISH MEDICAL JOURNAL (2017)
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13
Courtney Davis et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Alison M. Pease et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
Cancer drugs: high price, uncertain value
Deborah Cohen
BMJ-BRITISH MEDICAL JOURNAL (2017)
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13
Courtney Davis et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Alison M. Pease et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014
Anthony J. Hatswell et al.
BMJ OPEN (2016)
Use of the Conditional Marketing Authorization Pathway for Oncology Medicines in Europe
J. Hoekman et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Overall Response Rate, Progression-Free Survival, and Overall Survival With Targeted and Standard Therapies in Advanced Non-Small-Cell Lung Cancer: US Food and Drug Administration Trial-Level and Patient-Level Analyses
Gideon M. Blumenthal et al.
JOURNAL OF CLINICAL ONCOLOGY (2015)
American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options
Lowell E. Schnipper et al.
JOURNAL OF CLINICAL ONCOLOGY (2015)
Outcomes and endpoints in cancer trials: bridging the divide
Michelle K. Wilson et al.
LANCET ONCOLOGY (2015)
Progression-free survival as a surrogate endpoint for overall survival in glioblastoma: a literature-based meta-analysis from 91 trials
Kelong Han et al.
NEURO-ONCOLOGY (2014)
Single-center trials tend to provide larger treatment effects than multicenter trials: a systematic review
Susanne Unverzagt et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2013)
Characteristics of Oncology Clinical Trials Insights From a Systematic Analysis of ClinicalTrials.gov
Bradford R. Hirsch et al.
JAMA INTERNAL MEDICINE (2013)
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)
Statistics in medicine - Reporting of subgroup analyses in clinical trials
Rui Wang et al.
NEW ENGLAND JOURNAL OF MEDICINE (2007)
Treating Individuals 2 - Subgroup analysis in randomised controlled trials: importance, indications, and interpretation
PM Rothwell
LANCET (2005)
Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: A review of guidance documents and performed authorizations of medicinal products 1995 to 2003
A Szende et al.
VALUE IN HEALTH (2005)
End points and United States food and drug administration approval of oncology drugs
JR Johnson et al.
JOURNAL OF CLINICAL ONCOLOGY (2003)
分享论文
