Abstract
Objective: To present a case study of the application of systematic review methods to the pharmacovigilance of drugs post-marketing.
Background: The methods of systematic review are evolving as a tool for health care decision makers to assist with the comprehensive assessment of large amounts of information. As the methods have evolved, so have the applications increased. This paper covers an application of systematic review methods to the field of pharmacovigilance of drugs in the postmarketing phase.
Methods: A systematic review of published literature addressing the safety of granulocyte-macrophage colony stimulating factor (GM-CSF) when used off-label in patients with HIV infection or AIDS is used. The methods applied to each step in the review are described to illustrate the general approach. Problems specific to this project, and those which are shared by all reviewers, are discussed along with the solutions.
Conclusion: This case study serves: 1. Other reviewers, by sharing this experience with a relatively new application of systematic review methods; 2. Readers of reviews, by highlighting the pros and cons of these review methods in the context of a real application, and 3. Industry and regulatory decision makers, by demonstrating another approach to enhancing pharmacovigilance of new drugs post-marketing.
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