Pre & Post Marketing Analysis

995 WordsMay 29, 20154 Pages
Pre & Post-Marketing Pharmacovigilance Reporting in the US: A Comparison of Adverse Event Reporting in Pre- and Post-Marketing Clinical Studies and Post-Marketing Spontaneous Reports When a drug is finally brought to the market, it usually has gone through three clinical trial phases in humans, including Phase 1, 2 and 3 clinical studies. Some drugs may be required to conduct a Phase 4 or post-marketing study after its approval in order to gather additional information about a product’s safety, efficacy or optimal use. Adverse events can occur in any of the clinical study phases (pre- or post-marketing), or when it has been marketed to the public after the drug’s approval. A pharmaceutical company (sponsor) or its delegated Contract…show more content…
• Quality Control: An alternate Drug Safety colleague performs quality control (QC) to verify the report for accuracy, clarity, consistency, and completeness of data entered in the safety database by comparing the source documents against the data entered into the safety database. • Medical Review A Medical Reviewer (physician) assess cases for medical aspects, which includes verifying adverse event coding, causality assessment, confirming event seriousness and expectedness, reviewing narratives, providing comments and requests for follow-up with the reporter. • Follow-up or Queries Queries are sent to the reporters for details of the adverse event and additional follow-up information which may add to the completed and clinical significance of the report.  Different Requirements for Adverse Event Reporting in Pre- and Post-Marketing Clinical Studies, and Post-Marketing Spontaneous cases: Although many steps of collecting adverse events reported in clinical studies and in the post-marketing setting are the same, there are some different requirements, which are summarized in the table below. Phase 1-3 Clinical Trials Post-Marketing Clinical Trials or Phase 4 Clinical Trials Post-Marketing Spontaneous Event Reporting (outside of a clinical trial) Database used to Enter Event Information • Clinical Database • Safety Database • Clinical Database • Safety Database • Safety Database Only (collected
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