Conducting long term follow up studies to ensure that life-saving therapies can be brought to patients safely is challenging. This places a burden on patients participating in the studies and operational challenges on life sciences study sponsors.
Connecting sources of real world data (RWD) to clinical trials data can create a more seamless process for conducting long-term follow up studies.
In this webinar, panelists will discuss how this approach enables many benefits, including the ability to:
- Supplement data for patients lost to follow up
- Augment trial data to help explain non-responders and adverse events
This approach can be particularly beneficial in specific therapeutic areas, including:
- Cell and gene therapies: high regulatory burden (up to 15 years of data collection)
- Oncology: endpoints such as overall survival can be assessed for Accelerated Approval
- COVID-19: exploration of delayed adverse events