Increasingly, payers and physicians are seeking real-world data on newly approved medications. Post-Authorisation Safety Studies (PASS) can provide this vital safety information and encourage market acceptance and uptake.
This year Partnerships in Clinical Trials Europe is bringing together clinical development outsourcing professionals to discuss “The era of change: A panoramic vision of reform, challenge and innovation in clinical trials.” With services that span Clinical Development, Late Stage Research and Safety, UBC is uniquely positioned to add our voice to the conversation.
A recent report from the Pharmacovigilance and Risk Assessment Committee (PRAC) found that in the 200+ study protocols reviewed, nearly half suffered from study design flaws. Don’t let methodological issues stall approval of your next Post-Authorisation Safety Study (PASS).
One of the biggest operational challenges with the design of registries, also called post-approval safety studies (PASS), is understanding the differences with clinical trials. Clinical trials involve subjects with very specific inclusion/exclusion criteria and protocol procedures, but registries take “all comers” with limited inclusion/exclusion criteria seen as part of routine care. Often sponsors design what they believe is a registry but is actually a post-approval study based upon clinical trial guidelines and SOPs.