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- White Paper on Imaging Biomarkers
- A New Way to Evaluate Randomized Controlled Trials? New Approach Does More Harm Than Good
- Clinical Trial Designs for Non‐Traditional Antibiotics
- The Adaptive Concept Benefits of Adaptive Trials
- Proposed Primary Endpoints for Use in Clinical Trials That Compare Treatment Options for Bloodstream Infection in Adults: a Consensus Definition
- Multiple Endpoints in Clinical Trials
- PIES Method of Critique
- “Efficacy Trials of ZIKV Vaccines: Endpoints, Trial Design, Site Selection”
- Slowly Progressive, Low-Prevalence
- Reviewing Clinical Trials: a Guide for the Ethics Committee
- Of Adaptive Design Clinical Trials for Drugs and Biologics Guidance
- COVID-19: Developing Drugs and Biological Products for Treatment Or Prevention Guidance for Industry
- Applying Meta-Analytic-Predictive Priors with the R Bayesian Evidence Synthesis Tools
- (Radiation) Therapy
- Endpoints in Vaccine Trials
- The Roopfs Study to Assess Whether Improved Housing Provides
- OUTCOME MEASURES USED in CRITICAL CARE TRIALS Systematic Review Protocol
- Clinical Adjudication Committees: Best Practices for Use in a Range of Study Designs
- FDA Briefing Document Developing Antibacterial Therapies Targeting A
- Trial Designs and Endpoints
- Clinical Trial Endpoints for the Approval of Non- Small Cell Lung Cancer Drugs and Biologics Guidance for Industry
- Outcomes, Surrogates, Composite Endpoints (Day)
- What Are the Regulatory Issues That Impact Endpoints for Prevention Trials?
- Innovative Clinical Study Design for Gene and Cell Therapies Jake Elkins, MD Head, Clinical Sciences Sarepta Therapeutics Problem Statement
- On Two-Stage Seamless Adaptive Design in Clinical Trials Shein-Chung Chow,1* Yi-Hsuan Tu2
- Endpoints in Respiratory Diseases Fernando Maria Benedictis, Roberto Guidi, Silvia Carraro, Eugenio Baraldi
- Seo Final Slides.Pdf
- The Spore Coat Protein Cote Facilitates Host Colonization by Clostridium Difficile
- Validation of Surrogate Endpoints for Clinical Trials
- The Clinical Endpoint Adjudication Handbook V2.0
- PFDD Public Workshop Guidance 3 Discussion Document
- Considerations for Discussion of a New Surrogate Endpoint(S) at a Type C PDUFA Meeting Request
- The Importance of Selecting Endpoints in Clinical Trials
- Non-Traditional Antibiotics: What Will It Take to Convincingly Develop a Virulence Inhibitor Or Similar Indirect Agent?
- Understanding Clinical Trial Design: a Tutorial for Research Advocates Understanding Clinical Trial Design: a Tutorial for Research Advocates
- How Can Viral Dynamics Models Inform Endpoint Measures in Clinical Trials of Therapies for Acute Viral Infections?
- Adaptive Methods: Telling ‘The Rest of the Story’
- Quantitative Medical Imaging for Clinical Research and Practice Educational Session ACRIN 2009
- Methods and Designs of Modern Breast Cancer Confirmatory Trials
- Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry
- Role of Surrogates in Clinical Trials
- FDA Draft Guidance, 2010
- Regulatory and Clinical Trial Considerations for Drug Development for Coccidioidomycosis
- Medical Imaging in Oncology Review
- Definitions and Validation Criteria for Biomarkers and Surrogate Endpoints: Development and Testing of a Quantitative Hierarchical Levels of Evidence Schema
- Clinical Trials Glossary