Details
Description
The Mini-Sentinel Supplement to Pharmacoepidemiology and Drug Safety provides a set of 34 articles that collectively describe the work of the FDA's Mini-Sentinel pilot in its early phase. Each article is also listed individually below.
Materials
Reports
- The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction
- The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety
- The Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot Program
- A Policy Framework for Public Health uses of Electronic Health Data
- Design Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data System
- Design Considerations in an Active Medical Product Safety Monitoring System
- Using High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance System
- When Should Case-Only Designs be used for Safety Monitoring of Medical Products?
- Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data
- Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot
- Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons Learned
- Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons Learned
- A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack using Administrative Data
- A Systematic Review of Validated Methods for Identifying Heart Failure using Administrative Data
- A Systematic Review of Validated Methods for Identifying Atrial Fibrillation using Administrative Data
- A Systematic Review of Validated Methods for Identifying Ventricular Arrhythmias using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Depression using Administrative Data
- A Systematic Review of Validated Methods for Identifying Suicide or Suicidal Ideation using Administrative or Claims Data
- A Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative Data
- A Systematic Review of Validated Methods for Identifying Lymphoma using Administrative Data
- A Systematic Review of Validated Methods for Identifying Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative Data
- A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Erythema Multiforme Major/Minor/Not otherwise specified, Stevens–Johnson Syndrome, or Toxic Epidermal Necrolysis using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Anaphylaxis, Including Anaphylactic Shock and Angioneurotic Edema, using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Acute Respiratory Failure using Administrative and Claims Data
- A Systematic Review of Validated Methods for Identifying Orthopedic Implant Removal and Revision using Administrative Data
- Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel
- A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent
- The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise