We conduct systematic literature reviews and meta-analyses to help clients:
- Find out what’s been done,
- Identify research gaps,
- Refine research questions,
- Assess medication efficacy and safety.
We use explicit protocols to identify and collect publications and documents, extract information, and synthesize results in an objective, replicable manner.
We follow the standards developed by such notable leaders as the Cochrane Collaboration and the Oxford Centre for Evidence Based Medicine.
Meta-analysis and drug labeling.
More and more frequently, information about adverse events can be summarized by combining the information in several randomized clinical trials. Trials that were powered to test efficacy hypotheses might be too small to allow hypothesis tests of adverse events, because the adverse events are rarer than the positive effects. When the information from these trials are pooled statistical testing for rare events may be possible.
Such analyses are now used by FDA, in combination with other processes, to assist in labeling and revisions to the drug label.
Case study
On May 5, 2009, FDA announced that manufacturers of antiepileptic drugs (AEDs) or anticonvulsant drugs will update product labeling to include a warning about an increased risk of suicidal thoughts or actions and will develop a Medication Guide to help patients understand this risk. Among the documents used to inform this decision was the May 23, 2008 statistical review reporting the meta-analysis conducted by the Agency.
Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality (PDF – 304KB)
