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