How to use FDA drug approval documents for evidence syntheses

Aviv Ladanie · Hannah Ewald · Benjamin Kasenda · Lars G. Hemkens

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Pharmaceutical industry and healthcare

Abstract

Evidence syntheses may benefit from using aggregated clinical trial information in approval documents published online by the US Food and Drug Administration (FDA). We provide practical guidance on how to access and use this source of information for evidence syntheses on treatment effects of drugs and therapeutic biologics.

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References

2008Cochrane Handbook for Systematic Reviews of Interventions 2007Practical methods for incorporating summary time-to-event data into meta-analysis 2020Cochrane Handbook for Systematic Reviews of Interventions 1998Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints 2012Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses 2003How useful are unpublished data from the Food and Drug Administration in meta-analysis?2013Searching for unpublished data for Cochrane reviews: cross sectional study 2016Most systematic reviews of adverse effects did not include unpublished data

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2020Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 2018The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs

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