Value and Utility vs. Challenges Webinar

Data Collection in Continued and Early Access Programs: Value and Utility vs. Challenges

Data collection opportunities in continued and early access programs vary by country and regulatory pathways, with limited guidance on effectiveness or health outcomes data collection. Some programs eliminate protocol and consent requirements, limiting data collection. While not a substitute for clinical trials, these programs can provide supplemental data for stakeholders. Data collection in these programs generates real-world data in broader patient populations, augmenting clinical trial outcomes and informing future real-world use. As early access programs and the use of real-world data increase, the benefits of collecting such data will grow.