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A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks.
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Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial
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Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care)Clinical Perspective.
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Data Science
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Are Adaptive Trials the Answer to Oncology Development Success?
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Replay: Dual Target Methods for Go/No-Go Decision Making
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Optimizing Phase 2 Trial Designs with Program-Level Simulations
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ENHANCING CLINICAL DATA QUALITY WITH SPECIALIZED FUNCTIONAL SERVICE PROVIDER MODEL
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Adaptive Clinical Trials
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Cytel: The World’s Largest Biometrics CRO
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LogXact 11 Brochure
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Independent Statistical Center Function
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EnForeSys Brochure
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The Model-Based Approach: A Better Way to Forecast Enrollment
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Bayesian Power Calculations: Probability of Success and Predictive Power
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East 6.4
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Cytel Provides a Seamless Solution for Independent Data Monitoring Committee Services
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Data Monitoring Committee Services
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Data Management Services
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Cytel Benefits
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Compass Brochure
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Clinical Data Services
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Cross-Study Efficiencies for Respiratory Clinical Trial Program
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Redesigning a Pragmatic Oncology Trial to Address Regulatory Agency Concerns
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Complex Questions from Regulatory Agency Required Rapid Response
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Exposure Response Information Needed in Phase 3
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Optimizing Biosimilar Development with an Adaptive Design Approach
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Innovative Phase 3 Adaptive Enrichment Design Reduces Development Risk in Rare Oncology Indication
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Flexible Dose Escalation Designs to Better Identify Maximum Tolerated Dose
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Combining Bayesian Decision-Making with Frequentist Final Analysis in Phase 3 Oncology Trial
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From Trial Design to CDISC Submission
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Custom Software Enhances Decision-Making
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PROCYSBI™ Approved with Cytel Support
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Biostatistics & Programming Outsourcing
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Adaptive Approaches in Oncology
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Simulation Tools for Optimal Designs
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Adaptive Trial Accelerates FDA Approval
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ADAPTIVE TRIALS, SOLID RESULTS When Innovation is Surer than Convention
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StatXact Brochure
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EnForeSys Brochure
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Cytel: The Industry’s Largest Biometrics CRO
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East Brochure
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Quantitative Pharmacology and Pharmacometrics
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ACES – A Cytel White Paper
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Design and Monitoring of Multi-arm Multi-stage Clinical Trials
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The Case for a Bayesian Approach to Benefit-Risk Assessment
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Efficiency Considerations for Group Sequential Designs with Adaptive Unblinded Sample Size Re-assessment
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Biomarker Driven Population Enrichment for Adaptive Oncology Trials With Time to Event Endpoints
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Exact Inference for Adaptive Group Sequential Designs
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Optimizing Trial Design; Sequential, Adaptive and Enrichment Strategies
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Repeated Confidence Intervals for Adaptive Group Sequential Trials
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A Network Algorithm for Performing Fisher’s Exact Test in r × c Contingency Tables
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Exact Permutational Tests for Group Sequential Clinical Trials
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Exact Logistic Regression: Theory and Examples
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Efficient Monte Carlo Methods for Conditional Logistic Regression
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Adaptive Increase in Sample Size When Interim Results are Promising: A Practical Guide with Examples
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Approaches for Clinical Supply Modelling and Simulation
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Early Clinical Development Planning via Biomarkers, Clinical Endpoints, and Simulation: A Case Study to Optimize for Phase 3 Dose Selection
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Biomarker Driven Population Enrichment for Adaptive Oncology Trials with Time to Event Endpoints
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Research Designs for Proof-of-Concept Chronic Pain Clinical Trials: IMMPACT Recommendations
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Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes
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Adaptive Sequential Testing for Multiple Comparisons
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Creating Value With Financially Adaptive Clinical Trials
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Evaluation of an Adaptive Maximizing Design Study Based on Clinical Utility Versus Morphine for TRV130 Proof-of-Concept and Dose-Regimen Finding in Patients With Postoperative Pain After Bunionectomy
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An Intra-Articular, Extended-Release Formulation of Triamcinolone Acetonide Prolongs and Amplifies Analgesic Effect in Patients With Osteoarthritis of the Knee: a Randomized Clinical Trial
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Impact of Phase 2b Strategies on Optimization of Drug Development Programs
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A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma
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Heart Failure and Mortality Outcomes in Patients With Type 2 Diabetes Taking Alogliptin vs. Placebo in EXAMINE: a Multicentre, Randomised, Double-blind Trial
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Vosaroxin Plus Cytarabine Versus Placebo Plus Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukaemia (VALOR): A Randomised, Controlled, Double-blind, Multinational, Phase 3 Study
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Drug Development and the Cost of Capital
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Methodological Extensions of Phase 2 Trial Designs Based on Program-level Considerations: Further Development of a Case Study in Neuropathic Pain
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DIA’s Adaptive Design Scientific Working Group (ADSWG) Best Practices Case Studies for “Less Well-understood” Adaptive Designs
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Comments on: “Some Challenges with Statistical Inference in Adaptive Designs”, by Hung, Wang, and Yang."
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Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs
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Adaptive Designs for Clinical Trials
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Angiotensin-converting Enzyme Inhibitor Use and Major Cardiovascular Outcomes in Type 2 Diabetes Mellitus Treated with the Dipeptidyl Peptidase 4 Inhibitor Alogliptin Novelty and Significance
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A Randomized, Phase 2 Study Investigating TRV130, a Biased Ligand of the μ-opioid Receptor, for the Intravenous Treatment of Acute Pain
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An Objective Re-evaluation of Adaptive Sample Size Re-estimation: Commentary on “Twenty-five Years of Confirmatory Adaptive Designs”
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Cytel-DIA Webinar | Need to Reinvent the Clinical Trial
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ACES: A Cytel White Paper by Eric Silva
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Optimizing Trial Design: Sequential, Adaptive, and Enrichment Strategies
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Sample Size Re-estimation for Adaptive Sequential Design in Clinical Trials
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Repeated Confidence Intervals for Adaptive Group Sequential Trials
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Exact Confidence Bounds Following Adaptive Group Sequential Tests
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Adaptive, Group Sequential and Decision Theoretic Approaches to Sample Size Determination
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Confidence Interval of the Difference of Two Independent Binomial Proportions Using Weighted Profile Likelihood
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Adaptive Sequential Testing for Multiple Comparisons
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A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials
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Alogliptin After Acute Coronary Syndrome in Patients with Type 2 Diabetes
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Exact inference for adaptive group sequential designs
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Small-Sample Comparisons of Confidence Intervals for the Difference of Two Independent Binomial Proportions
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Choice of Test for Association in Small Sample Unordered R x C Tables
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Association and Haplotype Analysis of the Insulin Degrading Enzyme IDE Gene
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Aspirin Prophylaxis in Patients at Low Risk for Cardiovascular Disease: A Systematic Review of All Cause Mortality
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Statistical Techniques for Comparing Measurers and Methods of Measurement: A Critical Review
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Exact Level and Power of Permutation, Bootstrap and Asymptotic Tests of Trend
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Exact Inference for Categorical Data
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Exact Permutational Tests for Group Sequential Clinical Trials
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SPSS Exact Tests for Windows
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Importance Sampling for Estimating Exact Probabilities in Permutational Inference
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On Computing an Exact Confidence Interval for the Common Odds Ratio in Several 2 x 2 Contingency Tables
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A Network Algorithm for Performing Fisher’s Exact Test in R x C Contingency Tables
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Bias Reduction and a Solution for Separation of Logistic Regression with Missing Covariate
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A Preliminary Investigation of Maximum Likelihood Logistic Regression versus Exact Logistic Regression
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A Modified Score Function Estimator for Multinomial Logistic Regression in Small Samples
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Efficient Monte Carlo Methods for Conditional Logistic Regression
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Exact Logistic Regression - Theory and Examples
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Comparing MLE, MUE and Firth Estimates for Logistic Regression
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Get the Dose Right
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Enforesys | Trial Data Analysis Sofware | Enrollment Forecasting
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East: Bayesian Power Calculations Infosheet
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East Architect Infosheet
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StatXact 10 | Free 30-Day Trial
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Adaptive Trials in Oncology Development
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Adaptive Trial and Data Analytics, Medical Writing and CDISC Migration Services