Abstract
We consider the management of safety signals that arise in the context of endpoint trials. Such trials have design features which permit the detection of signals that otherwise may be missed in more traditional settings. However, the approaches that are typically employed to address them are less than satisfactory in terms of both the analytical techniques and the communication of the findings. In this paper, alternative approaches are evaluated, and recommendations are given for a comprehensive strategy that involves appropriate use of study data as well as information external to the study. It is emphasized that formulation and implementation of an effective communication plan that enables informed decision making should be an integral component of the strategy.
Keywords: Endpoint trials, competing risks, safety evaluation, cardiovascular risk
Current Drug Safety
Title: Managing Safety Signals in Large Endpoint Trials
Volume: 3 Issue: 2
Author(s): Demissie Alemayehu
Affiliation:
Keywords: Endpoint trials, competing risks, safety evaluation, cardiovascular risk
Abstract: We consider the management of safety signals that arise in the context of endpoint trials. Such trials have design features which permit the detection of signals that otherwise may be missed in more traditional settings. However, the approaches that are typically employed to address them are less than satisfactory in terms of both the analytical techniques and the communication of the findings. In this paper, alternative approaches are evaluated, and recommendations are given for a comprehensive strategy that involves appropriate use of study data as well as information external to the study. It is emphasized that formulation and implementation of an effective communication plan that enables informed decision making should be an integral component of the strategy.
Export Options
About this article
Cite this article as:
Alemayehu Demissie, Managing Safety Signals in Large Endpoint Trials, Current Drug Safety 2008; 3 (2) . https://dx.doi.org/10.2174/157488608784529206
DOI https://dx.doi.org/10.2174/157488608784529206 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
New Therapeutic Aspects of Inflammatory Cardiomyopathy
Current Pharmaceutical Design Echocardiogram versus Cardiac Magnetic Resonance Imaging for the Diagnosis of Non-compaction Cardiomyopathy – A Case Report
New Emirates Medical Journal Modulation of Cardiovascular Function by Adipokines
Cardiovascular & Hematological Disorders-Drug Targets Predementia and Dementia Syndromes: Possible Role of Lipoprotein Metabolism
Vascular Disease Prevention (Discontinued) Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease (COPD): Focus on Virus Induced Exacerbations
Current Pharmaceutical Design Stem Cell Regenerative Potential Combined with Nanotechnology and Tissue Engineering for Myocardial Regeneration
Current Stem Cell Research & Therapy Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein 1: Recent Developments Concerning Substrates and Inhibitors of a Promising Therapeutic Target
Current Medicinal Chemistry Vaccines for Patients with COPD
Recent Patents on Inflammation & Allergy Drug Discovery Machine Learning Based Support System for Students to Select Stream (Subject)
Recent Advances in Computer Science and Communications Pharmacogenomic Research in South Africa: Lessons Learned and Future Opportunities in the Rainbow Nation
Current Pharmacogenomics and Personalized Medicine Angiogenesis-regulating microRNAs and Ischemic Stroke
Current Vascular Pharmacology Metabolic Obesity: The Paradox Between Visceral and Subcutaneous Fat
Current Diabetes Reviews Recent Advances and Patents on Mechanical Circulatory Support Devices
Recent Patents on Biomedical Engineering (Discontinued) Network-Based Strategies Can Help Mono- and Poly-pharmacology Drug Discovery: A Systems Biology View
Current Pharmaceutical Design Prevention of Cardiovascular Complications in the Marfan Syndrome
Vascular Disease Prevention (Discontinued) Protocatechuic Acid and Human Disease Prevention: Biological Activities and Molecular Mechanisms
Current Medicinal Chemistry Different Omega-3 Formulations Yield to Diverse Clinical Response: A Case-Report
Current Drug Safety Antioxidant Therapy Against Trypanosome Infections: A Review Update
Current Topics in Medicinal Chemistry The Role of the Stress-Related Anti-Inflammatory Hormones ACTH and Cortisol in Atherosclerosis
Current Vascular Pharmacology Drug Treatment of Metabolic Syndrome
Current Clinical Pharmacology