Surrogate end points in clinical trials: are we being misled?

scientific article published on October 1996

Surrogate end points in clinical trials: are we being misled? is …
instance of (P31):
review articleQ7318358
scholarly articleQ13442814

External links are
P356DOI10.7326/0003-4819-125-7-199610010-00011
P698PubMed publication ID8815760

P2093author name stringDeMets DL
Fleming TR
P433issue7
P407language of work or nameEnglishQ1860
P304page(s)605-613
P577publication date1996-10-01
P1433published inAnnals of Internal MedicineQ564416
P1476titleSurrogate end points in clinical trials: are we being misled?
P478volume125

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Q90707929Reasonable patient care under uncertainty
Q38171376Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer.
Q30624174Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints
Q36107913Redefining efficacy of antihypertensive therapies beyond blood pressure reduction--the role of angiotensin II antagonists
Q40355155Regulatory issues in aging pharmacology
Q46286212Related causal frameworks for surrogate outcomes
Q92666233Relation between therapy-induced changes in natriuretic peptide levels and long-term therapeutic effects on mortality in patients with heart failure and reduced ejection fraction
Q43842238Relationships Between Bone Mineral Density and Incident Vertebral Fracture Risk with Raloxifene Therapy
Q37164202Repairing the human brain after stroke. II. Restorative therapies
Q86880612Reply: Idiopathic Pulmonary Fibrosis: Perspectives on Clinically Meaningful Primary Endpoints in Phase 3 Clinical Trials
Q37865193Reporting Results of Obstructive Sleep Apnea Syndrome Surgery Trials
Q46255750Reporting Trends of Outcome Measures in Phase II and Phase III Trials Conducted in Advanced-Stage Non-small-cell Lung Cancer
Q30278453Research as a Standard of Care in the PICU.
Q39087428Research in the Integration of Behavioral Health for Adolescents and Young Adults in Primary Care Settings: A Systematic Review
Q31172444Response criteria for glioma
Q43677725Response to Hemilä. Did not record upper respiratory tract infection (URTI) symptoms/episodes.
Q42050412Retention loss of resin based fissure sealants - a valid predictor for clinical outcome?
Q34377514Rethinking Phase II Clinical Trial Design in Heart Failure
Q49346082Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products
Q36880257Risks and benefits associated with novel phase 1 oncology trial designs
Q36771454Role of biomarkers in developing new therapies for vascular disease
Q37762244Role of interleukin-2 in patients with HIV infection
Q38753960SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis
Q52025987Seamlessly expanding a randomized phase II trial to phase III.
Q50919126Sharp bounds on causal effects using a surrogate endpoint
Q34128493Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion
Q34193514Shortcomings in the clinical evaluation of new drugs: acute myeloid leukemia as paradigm
Q48288136Should we rely on trials with disease- rather than patient-oriented endpoints?
Q64936395Silent brain infarcts on diffusion-weighted imaging after carotid revascularisation: A surrogate outcome measure for procedural stroke? A systematic review and meta-analysis.
Q98612742Simple Methods for Evaluating 4 Types of Biomarkers: Surrogate Endpoint, Prognostic, Predictive, and Cancer Screening
Q79547880Small trials focusing on surrogate end points may be uninformative
Q27690715Soluble biomarkers and morbidity and mortality among people infected with HIV: summary of published reports from 1997 to 2010
Q39067727Spinal Arachnoiditis as a Complication of Cryptococcal Meningoencephalitis in Non-HIV Previously Healthy Adults.
Q37910402Statistical Considerations for the Next Generation of Clinical Trials
Q38590481Statistical approaches for evaluating surrogate outcomes in clinical trials: A systematic review.
Q35035407Statistical challenges in the evaluation of surrogate endpoints in randomized trials
Q38093778Statistical challenges in the evaluation of treatments for small patient populations
Q38389980Statistical considerations and endpoints for clinical lung cancer studies: Can progression free survival (PFS) substitute overall survival (OS) as a valid endpoint in clinical trials for advanced non-small-cell lung cancer?
Q38356102Statistical evaluation of surrogate endpoints with examples from cancer clinical trials
Q35743846Statistical issues in interpreting clinical trials
Q52053140Statistics and ethics in medical research
Q37045677Statistics in the world of medical devices: the contrast with pharmaceuticals
Q42111189Steroids in late ARDS?
Q33815608Strategy for randomised clinical trials in rare cancers
Q36239075Study designs and statistical analyses for biomarker research
Q44081925Substantial evidence of effect
Q33904238Sufficient conditions for concluding surrogacy based on observed data
Q90130287Summary of the Third Annual Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling
Q74776334Surgery on trial: An account of clinical trials evaluating operations
Q31032558Surgical outcomes research based on administrative data: inferior or complementary to prospective randomized clinical trials?
Q49379758Surgical treatment of the residual periodontal pocket
Q74282231Surrogacy in HIV-1 clinical trials
Q35197313Surrogacy marker paradox measures in meta-analytic settings
Q36215439Surrogate End Points for Overall Survival in Loco-Regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis
Q39233456Surrogate End Points for Overall Survival in Metastatic, Locally Advanced, or Unresectable Pancreatic Cancer: A Systematic Review and Meta-Analysis of 24 Randomized Controlled Trials
Q45004664Surrogate End Points in Secondary Analyses of Cardiovascular Trials
Q36407392Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.
Q42680159Surrogate Endpoints in Suicide Research
Q47246348Surrogate disease markers as substitutes for chronic disease outcomes in studies of diet and chronic disease relations
Q44019265Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy
Q44140689Surrogate end points as a clinical and public health problem. The cerivastatin case
Q73599528Surrogate end points in cardiovascular disease trials
Q34564309Surrogate end points in heart failure
Q78032634Surrogate end points in heart failure
Q35792872Surrogate end points in pulmonary arterial hypertension: assessing the response to therapy
Q40086308Surrogate end points: hopes and perils
Q37755085Surrogate end points: how well do they represent patient-relevant end points?
Q33600372Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists
Q35203994Surrogate endpoints in Parkinson's disease research
Q52614515Surrogate endpoints in global health research: still searching for killer apps and silver bullets?
Q27022533Surrogate endpoints in liver surgery related trials: a systematic review of the literature
Q77597779Surrogate endpoints: the debate goes on
Q44835530Surrogate endpoints: wishful thinking or reality?
Q42858959Surrogate measures and consistent surrogates
Q37556678Surrogate outcomes in health technology assessment: an international comparison
Q37400903Surrogate outcomes: experiences at the Common Drug Review
Q39723955Surrogates, meta-analysis and cost-effectiveness modelling: a combined analytic approach
Q50540545Symptoms and clinical relevance: A dilemma for clinical trials on prevention of venous thromboembolism
Q34003646Systematic review: renal and other clinically relevant outcomes in hepatorenal syndrome trials
Q42694128TROG 96.01: TTBF and PSAdt as surrogates for disease specific mortality
Q40048909Targeting cancer with peptide aptamers.
Q47393668Tc-99m sestamibi infarct size as a surrogate endpoint
Q30765072Test the reliability of doubly robust estimation with missing response data
Q36966415The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogat
Q38115845The Evidence-based Medicine Paradigm: Where are We 20 Years Later? Part 1
Q59807329The Influence of Upper and Lower Extremity Strength on Performance-Based Sarcopenia Assessment Tests
Q46125002The Monocyte and Acute Respiratory Distress Syndrome: Implicated, Innocent Bystander, or Awash in Research Translation?
Q32089020The National Patient Library: Evidence-based Information for Consumers
Q37982642The Role of Intravascular Ultrasound in the Determination of Progression and Regression of Coronary Artery Disease
Q44203609The aftermath of orbital radiotherapy for graves' ophthalmopathy
Q33961751The application of biomarkers in clinical trials for motor neuron disease
Q94370485The authors reply
Q42811213The calibration of treatment effects from clinical trials to target populations
Q35058214The challenges of conducting clinical endpoint studies
Q77931311The coxib story: some lessons and more questions
Q34646490The effects of organic nitrates on osteoporosis: a randomized controlled trial [ISRCTN94484747]
Q77348021The efficacy of silver alloy-coated urinary catheters in preventing urinary tract infection: a meta-analysis
Q28290097The flawed basis for FDA post-marketing safety decisions: the example of anti-depressants and children
Q36327987The future of multiple sclerosis therapies: redesigning multiple sclerosis clinical trials in a new therapeutic era.
Q77940033The importance of randomized clinical trials and evidence-based medicine: a clinician's perspective
Q48113290The inherent ethical challenge of first-in-human pluripotent stem cell trials
Q40127940The intermediate endpoint effect in logistic and probit regression.
Q35758558The new FDA labeling for ESA--implications for patients and providers
Q33283655The opportunities and challenges of developing imaging biomarkers to study lung function and disease
Q74063439The phase II/III transition. Toward the proof of efficacy in cancer clinical trials
Q51811225The points for pacing
Q35145713The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases
Q28652185The potential risks of expedited approval of drugs for acute bacterial infections
Q34570123The promise and peril of surrogate end points in cancer research
Q38529746The promise of biomarkers in diagnosing major depression in primary care: the present and future
Q39227462The relationship between study design, results, and reporting of randomized clinical trials of HIV infection
Q43241792The road from discovery to clinic: adiponectin as a biomarker of metabolic status
Q73599503The role of clinical nonfatal end points in cardiovascular phase II/III clinical trials
Q48938444The role of noninvasive imaging techniques in the assessment of stem cell therapy after acute myocardial infarction
Q31027711The saccadic and neurological deficits in type 3 Gaucher disease
Q79342335The statin wars
Q37714961The statistical interpretation of pilot trials: should significance thresholds be reconsidered?
Q36259760The true treatment benefit is unpredictable in clinical trials using surrogate outcome measured with diagnostic tests
Q36213997The ultimate model organism: progress in experimental medicine
Q37174835The use and abuse of surrogate endpoints in clinical research in transfusion medicine
Q37099269The use of pharmacoeconomic evidence to support formulary decision making in Saudi Arabia: Methodological recommendations.
Q34518494The use of surrogate endpoints in clinical trials: focus on clinical trials in cardiovascular diseases
Q28543430The use of surrogate endpoints in regulating medicines for cardio-renal disease: opinions of stakeholders
Q48411049The uses of biomarkers in drug development
Q37418999The validity of biomarkers as surrogate endpoints in Alzheimer's disease by means of the Quantitative Surrogate Validation Level of Evidence Scheme (QSVLES).
Q37777027Thiazolidinediones and Cardiovascular Risk — A Question of Balance
Q37687209Thinking on how to construct the system of Chinese medicine efficacy evaluation for coronary heart disease angina pectoris
Q34627722Thromboembolism in orthopaedics--observation and experiment
Q26797292Timing and extent of response in colorectal cancer: critical review of current data and implication for future trials
Q36141341Tissue Biomarkers for Prostate Cancer Radiation Therapy
Q42159672Toward a more complete understanding of the association between a hepatitis C sustained viral response and cause-specific outcomes
Q37963823Toxicity as a Biomarker of Efficacy of Molecular Targeted Therapies: Focus on EGFR and VEGF Inhibiting Anticancer Drugs
Q35466780Tranexamic acid for traumatic brain injury: a systematic review and meta-analysis
Q37118543Translating cancer trial endpoints into the language of managed care
Q36401418Translational research in central nervous system drug discovery
Q37602380Translational research in phase I trials
Q45252579Treatment effects on patient-important outcomes can be small, even with large effects on surrogate markers
Q35128447Trends in clinical trials in surgical oncology: Implications for outcomes research
Q34069060Tumor angiogenesis: molecular pathology, therapeutic targeting, and imaging
Q50316530Tyranny of the randomised clinical trial
Q61446772Ultra-short term HRV features as surrogates of short term HRV: a case study on mental stress detection in real life
Q33792262Understanding controlled trials: what outcomes should be measured?
Q35832654Unproven stem cell-based interventions and achieving a compromise policy among the multiple stakeholders
Q48196689Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?
Q43006251Upper gastrointestinal bleeding and surrogate end points
Q34005969Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial
Q50205884Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework.
Q36329179Use of surrogate outcomes in US FDA drug approvals, 2003-2012: a survey.
Q37363374Use of surrogate outcomes in cost-effectiveness models: a review of United Kingdom health technology assessment reports
Q41138627Users' guide to the surgical literature: how to assess an article using surrogate end points
Q36039936Using imaging biomarkers to accelerate drug development and clinical trials
Q28475480Valganciclovir for cytomegalovirus prevention in solid organ transplant patients: an evidence-based reassessment of safety and efficacy
Q37857651Validated surrogate endpoints needed for peri-implantitis
Q34541733Validation of 6-Minute Walk Distance as a Surrogate End Point in Pulmonary Arterial Hypertension Trials
Q30412999Validation of a clinical assessment of spectral-ripple resolution for cochlear implant users
Q53647133Validation of educational assessments: a primer for simulation and beyond
Q33394106Validation of novel imaging methodologies for use as cancer clinical trial end-points
Q38259501Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.
Q38796580Validation of surrogate endpoints in cancer clinical trials via principal stratification with an application to a prostate cancer trial.
Q45192037Validation of surrogate markers in multiple randomized clinical trials with repeated measurements: canonical correlation approach
Q30486476Validity of sealant retention as surrogate for caries prevention--a systematic review
Q44964642Valuation of biomarkers
Q58375638Venous thromboembolism prophylaxis: do trial results enable clinicians and patients to evaluate whether the benefits justify the risk? Proceedings of an Ad Hoc Working Group Meeting
Q80141701Vitamin C and exercise-induced immunodepression
Q91975906Vitamin E and Mortality in Male Smokers of the ATBC Study: Implications for Nutritional Recommendations
Q36694617Volume-based growth tumor kinetics as a prognostic biomarker for patients with EGFR mutant lung adenocarcinoma undergoing EGFR tyrosine kinase inhibitor therapy: a case control study
Q24613362What are biomarkers?
Q30452941What happened to the valid POEMs? A survey of review articles on the treatment of type 2 diabetes
Q38750761What is effective care for varicose veins?
Q37401864What is treatment success in cardiac resynchronization therapy?
Q92348246When to keep it simple - adaptive designs are not always useful
Q91504592White matter hyperintensities mediate gray matter volume and processing speed relationship in cognitively unimpaired participants
Q37378390Whither osteoarthritis biomarkers?
Q24707972Why Most Clinical Research Is Not Useful
Q24633018Zinc lozenges may shorten the duration of colds: a systematic review
Q73600149[Clinical trials--what is the question?]
Q73600154[Statistically significant--also relevant for the patient?]
Q74267259[The dubious relationship between peer-review and quality]

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