DIA/FDA Best Practices for Regulatory Information Synthesis of Randomized Trials for Product Safety Evaluation

Discuss Major Themes and Best Practices in Regulatory Information Synthesis of Randomized
Trials for Product Safety Evaluation.

Regulators and sponsors need to continually assess the risk-benefit of medical
products throughout the life-cycle. When a safety issue is identified in a development
program the issue is addressed prospectively in the program safety
analysis plan with a goal to combine the data across studies. In the absence
of large-scale confirmatory studies on the safety of products it is necessary to
synthesize the available scientific evidence. A regulatory information synthesis
(RIS) includes the systematic review and a meta-analysis, if appropriate
to combine data across studies. Guidance on best practices for RIS enhances
transparency, objectivity, reproducibility, consistency and interpretation. RIS is
an important tool in safety evaluation and is one of several sources of evidence
that is considered in support of risk-benefit decisions in the regulatory setting.
Those who have suggestions or comments regarding this topic may
communicate via E-mail to: meta-analysis_guidance@fda.hhs.gov

KEYNOTE SPEAKER
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)