RWD provides valuable insights that can advance research and improve care for people with PSC by:
- Offering a more complete picture of how the disease progresses in real-world settings in a broader range of patients
- Helping identify early indicators that predict long-term outcomes
- Supporting external control groups, reducing the need for placebo arms
- Accelerating the development of new therapies and strengthening trial design
For patients, this means their routine care can directly contribute to research — turning everyday data into insights that drive faster, safer therapy development.
What are the Challenges in Using RWD?
To be useful for regulators, RWD must be accurate, complete, and reliable. Key challenges include:
- Uncertain accuracy and incomplete information: Data recorded during routine care may be missing or documented inconsistently across clinics, reducing overall reliability.
- Lack of outcome verification: Important clinical events—such as hospitalizations, new complications, or major changes in symptoms—are often not independently reviewed or confirmed against source medical records.
- Limited capture of safety events: Possible side effects or other health problems are typically not systematically recorded or validated in real-world datasets, making it difficult to assess risks accurately.
These issues underscore the need for structured, prospective, and scientifically rigorous data collection.
