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How to use FDA drug approval documents for evidence syntheses

Year: 2018

Type: article

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.

Source: BMJ

DOI: 10.1136/bmj.k2815

Authors: Aviv Ladanie, Hannah Ewald, Benjamin Kasenda, Lars G Hemkens

Institutions: Swiss Tropical and Public Health Institute, University of Basel, University Hospital of Basel

Language: English

Topic: Meta-analysis and systematic reviews

Subfield: Statistics, Probability and Uncertainty

Field: Decision Sciences

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: bronze

OpenAlex ID: W2857283752