Want more on real world evidence? Download recordings of three exclusive sessions from the DIA 2019 Global Annual Meeting discussing the future of RWE in the life sciences industry:
Use of Real World Evidence to Support Regulatory Decision-Making: First Year Findings from the RCT-DUPLICATE Project
The Cures Act and PDFUA IV mandated that the US FDA develop rules to guide industry on the use of RWE for drug approvals. Here, researchers and regulators describe the DUPLICATE project, provide an interim update on findings from its first year, discuss key considerations in implementing non-randomized studies using RWE, and facilitate discussion on how RWE may be used in regulatory decision-making.
Current Status of FDA Framework for the Evaluation of RWE
Gain key takeaways from public comments about the RWE framework, and get an update on the current status of the FDA RWE Program from FDA officials.
When is Real World Evidence Ready for Prime Time?
There is growing interest in the value of using real world data to support label expansions and approvals of drugs for rare conditions and oncology projects. Learn key lessons from demonstration projects to understand what is being done to evaluate data sets to give confidence in a real world study design, and its findings, including challenges encountered when comparing clinical trial data with a medicine's performance in clinical practice.