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。Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union
Jarno Hoekman et al.
SOCIAL SCIENCE & MEDICINE (2019)
Selection of Endpoints in Clinical Trials: Trends in European Marketing Authorization Practice in Oncological Indications
Anna Kordecka et al.
VALUE IN HEALTH (2019)
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)
Surrogate endpoints in randomised controlled trials: a reality check
Shaji Kumar et al.
LANCET (2019)
RoB 2: a revised tool for assessing risk of bias in randomised trials
Jonathan A. C. Sterne et al.
BMJ-BRITISH MEDICAL JOURNAL (2019)
A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology
Alyson Haslam et al.
EUROPEAN JOURNAL OF CANCER (2019)
Association between progression-free survival and patients' quality of life in cancer clinical trials
Thomas J. Hwang et al.
INTERNATIONAL JOURNAL OF CANCER (2019)
Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications
Steven Woloshin et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2018)
EMA recommended 35 new drugs in 2017
Asher Mullard
NATURE REVIEWS DRUG DISCOVERY (2018)
2017 FDA drug approvals The FDA approved 46 new drugs last year, the highest total in more than two decades
Asher Mullard
NATURE REVIEWS DRUG DISCOVERY (2018)
Do drugs offering only PFS maintain quality of life sufficiently from a patient's perspective? Results from AVALPROFS (Assessing the 'VALue' to patients of PROgression Free Survival) study
V. Jenkins et al.
SUPPORTIVE CARE IN CANCER (2018)
How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider
Tony Tse et al.
BMJ-BRITISH MEDICAL JOURNAL (2018)
How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider
Tony Tse et al.
BMJ-BRITISH MEDICAL JOURNAL (2018)
Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour
Jianrong Zhang et al.
BMJ OPEN (2018)
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)
Reporting harms more transparently in trials of cancer drugs
Bishal Gyawali et al.
BMJ-BRITISH MEDICAL JOURNAL (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)
The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors
Alex Hodkinson et al.
SYSTEMATIC REVIEWS (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)
Therapeutic aims of drugs offering only progression-free survival are misunderstood by patients, and oncologists may be overly optimistic about likely benefits
L. J. Fallowfield et al.
SUPPORTIVE CARE IN CANCER (2017)
Biases in Randomized Trials A Conversation Between Trialists and Epidemiologists
Mohammad Ali Mansournia et al.
EPIDEMIOLOGY (2017)
Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration
Huseyin Naci et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)
Unreported formal assessment of unblinding occurred in 4 of 10 randomized clinical trials, unreported loss of blinding in 1 of 10 trials
Segun Bello et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2017)
Delivery of meaningful cancer care: a retrospective cohort study assessing cost and benefit with the ASCO and ESMO frameworks
Joseph C. Del Paggio et al.
LANCET ONCOLOGY (2017)
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)
Conditional approval of medicines by the EMA
Rita Banzi et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
The wider role of regulatory scientists
Peter Doshi et al.
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)
Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study
Agnes Dechartres et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
Conditional approval of medicines by the EMA
Rita Banzi et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
The wider role of regulatory scientists
Peter Doshi et al.
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)
Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study
Agnes Dechartres et al.
BMJ-BRITISH MEDICAL JOURNAL (2017)
Economics of Cancer Medicines: For Whose Benefit?
Bishal Gyawali et al.
NEW BIOETHICS-A MULTIDISCIPLINARY JOURNAL OF BIOTECHNOLOGY AND THE BODY (2017)
National trends in prescription drug expenditures and projections for 2017
Glen T. Schumock et al.
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY (2017)
Do patient access schemes for high-cost cancer drugs deliver value to society?-lessons from the NHS Cancer Drugs Fund
A. Aggarwal et al.
ANNALS OF ONCOLOGY (2017)
Bias in reporting of randomised clinical trials in oncology
Francisco E. Vera-Badillo et al.
EUROPEAN JOURNAL OF CANCER (2016)
Relevance of randomised controlled trials in oncology
Ian F. Tannock et al.
LANCET ONCOLOGY (2016)
Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies
Matthew J. Page et al.
PLOS ONE (2016)
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)
Allocation concealment in randomised controlled trials: are we getting better?
Laura Clark et al.
BMJ-BRITISH MEDICAL JOURNAL (2016)
Epidemiology and Reporting Characteristics of Systematic Reviews of Biomedical Research: A Cross-Sectional Study
Matthew J. Page et al.
PLOS MEDICINE (2016)
Allocation concealment in randomised controlled trials: are we getting better?
Laura Clark et al.
BMJ-BRITISH MEDICAL JOURNAL (2016)
An Appraisal of Clinically Meaningful Outcomes Guidelines for Oncology Clinical Trials
Hemanth Kumar et al.
JAMA ONCOLOGY (2016)
The role of censoring on progression free survival: Oncologist discretion advised
Vinay Prasad et al.
EUROPEAN JOURNAL OF CANCER (2015)
Influence of censoring on conclusions of trials for women with metastatic breast cancer
Arnoud J. Templeton et al.
EUROPEAN JOURNAL OF CANCER (2015)
Approvals of drugs with uncertain benefit-risk profiles in Europe
Rita Banzi et al.
EUROPEAN JOURNAL OF INTERNAL MEDICINE (2015)
Risk of bias of randomized trials over time
Ludovic Reveiz et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2015)
The history and fate of the gold standard
David S. Jones et al.
LANCET (2015)
Avoidable waste of research related to inadequate methods in clinical trials
Youri Yordanov et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports
Michael Koehler et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Why the drug development pipeline is not delivering better medicines
Huseyin Naci et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Why do cancer drugs get such an easy ride?
Donald W. Light et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study
Iosief Abraha et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Avoidable waste of research related to inadequate methods in clinical trials
Youri Yordanov et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports
Michael Koehler et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Why the drug development pipeline is not delivering better medicines
Huseyin Naci et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Why do cancer drugs get such an easy ride?
Donald W. Light et al.
BMJ-BRITISH MEDICAL JOURNAL (2015)
Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study
Iosief Abraha et al.
BMJ-BRITISH MEDICAL JOURNAL (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)
Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy
O. Bylicki et al.
ANNALS OF ONCOLOGY (2015)
How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers' views
G. Tafuri et al.
ANNALS OF ONCOLOGY (2014)
Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
Asbjorn Hrobjartsson et al.
INTERNATIONAL JOURNAL OF EPIDEMIOLOGY (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)
The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications
Segun Bello et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2014)
Adverse Event Reporting in Cancer Clinical Trial Publications
Shanthi Sivendran et al.
JOURNAL OF CLINICAL ONCOLOGY (2014)
Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments-A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment
Michael Berntgen et al.
VALUE IN HEALTH (2014)
Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports
T. Jefferson et al.
BMJ Open (2014)
Unintended Consequences of Expensive Cancer Therapeutics-The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity The John Conley Lecture
Tito Fojo et al.
JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY (2014)
Assessing baseline imbalance in randomised trials: implications for the Cochrane risk of bias tool
Mark S. Corbett et al.
RESEARCH SYNTHESIS METHODS (2014)
Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer
F. E. Vera-Badillo et al.
ANNALS OF ONCOLOGY (2013)
Missing Data and Measurement Variability in Assessing Progression-Free Survival Endpoint in Randomized Clinical Trials
Rajeshwari Sridhara et al.
CLINICAL CANCER RESEARCH (2013)
Can trial quality be reliably assessed from published reports of cancer trials: evaluation of risk of bias assessments in systematic reviews
Claire L. Vale et al.
BMJ-BRITISH MEDICAL JOURNAL (2013)
Differential dropout and bias in randomised controlled trials: when it matters and when it may not
Melanie L. Bell et al.
BMJ-BRITISH MEDICAL JOURNAL (2013)
Searching for unpublished data for Cochrane reviews: cross sectional study
Jeppe Bennekou Schroll et al.
BMJ-BRITISH MEDICAL JOURNAL (2013)
Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data
Beate Wieseler et al.
PLOS MEDICINE (2013)
Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials
Jelena Savovic et al.
ANNALS OF INTERNAL MEDICINE (2012)
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)
Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols
Rahul Mhaskar et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2012)
Progression-Free Survival: Meaningful or Simply Measurable?
Christopher M. Booth et al.
JOURNAL OF CLINICAL ONCOLOGY (2012)
Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations
Keith T. Flaherty et al.
NEW ENGLAND JOURNAL OF MEDICINE (2012)
Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review
Lucy Turner et al.
SYSTEMATIC REVIEWS (2012)
Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
Asbjorn Hrobjartsson et al.
BMJ-BRITISH MEDICAL JOURNAL (2012)
Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications
Beate Wieseler et al.
BMJ-BRITISH MEDICAL JOURNAL (2012)
Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials?
Francesco Pignatti et al.
EUROPEAN JOURNAL OF CANCER (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)
Blinded versus unblinded assessments of risk of bias in studies included in a systematic review
Kate Morissette et al.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS (2011)
The Cochrane Collaboration's tool for assessing risk of bias in randomised trials
Julian P. T. Higgins et al.
BMJ-BRITISH MEDICAL JOURNAL (2011)
CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
David Moher et al.
BMJ-BRITISH MEDICAL JOURNAL (2010)
Role of Sensitivity Analyses in Assessing Progression-Free Survival in Late-Stage Oncology Trials
Suman Bhattacharya et al.
JOURNAL OF CLINICAL ONCOLOGY (2009)
Issues in Using Progression-Free Survival When Evaluating Oncology Products
Thomas R. Fleming et al.
JOURNAL OF CLINICAL ONCOLOGY (2009)
The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study
Eveline Nueesch et al.
BMJ-BRITISH MEDICAL JOURNAL (2009)
Evolution of the Randomized Controlled Trial in Oncology Over Three Decades
Christopher M. Booth et al.
JOURNAL OF CLINICAL ONCOLOGY (2008)
Reflections on medical oncology: 25 years of clinical trials - Where have we come and where are we going?
Christopher M. Booth et al.
JOURNAL OF CLINICAL ONCOLOGY (2008)
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes:: meta-epidemiological study
Lesley Wood et al.
BMJ-BRITISH MEDICAL JOURNAL (2008)
Stopping at nothing? Some dilemmas of data monitoring in clinical trials
Steven N. Goodman
ANNALS OF INTERNAL MEDICINE (2007)
Blinded trials taken to the test:: an analysis of randomized clinical trials that report tests for the success of blinding
A. Hrobjartsson et al.
INTERNATIONAL JOURNAL OF EPIDEMIOLOGY (2007)
Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments:: A systematic review
Isabelle Boutron et al.
PLOS MEDICINE (2006)
Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
HP Soares et al.
BRITISH MEDICAL JOURNAL (2004)
Allocation concealment in randomised trials: defending against deciphering
KF Schulz et al.
LANCET (2002)
分享论文
