Learn more about the use of real-world data (RWD) for regulatory processes from two presentations held at a recent CONNECT meeting.
CONNECT Working Group 4 hosted a digital seminar on 25 May 2021 gathering almost 60 representatives from the entire CONNECT consortium.
The topic "Possibilities and hurdles in using RWD in regulatory and reimbursement processes" was addressed by two experts from the public and private sector. Anja Schiel, Special Adviser and Lead Methodologist in Regulatory and Pharmacoeconomic Statistics from the Norwegian Medicines Agency talked about "RWD in regulatory processes, hurdles and possibilities from the regulatory authority perspective".
"I hope that the overview helps with understanding the regulatory and HTA challenges which are often misinterpreted as lack of willingness to use RWD when in reality they just reflect very real, mostly qualitative, shortcomings that need to be addressed before RWD can live up to the expectations in all areas of use," commented Schiel.
Her comprehensive presentation was complemented by Leah Burns, Director, WW HEOR, RWE Strategy, Bristol Myers Squibb joining the meeting from BMS’ Princeton office. Leah addressed the generation and use of RWD from a pharmaceutical company perspective in her talk titled “Real-world evidence for regulatory use”.
The talks covered both, the EMA and FDA perspectives and were followed by a lively discussion moderated by Gry Strand Festervoll, Senior Medical Manager BMS and Jesper Rimestad, Value Demonstration Lead at Takeda.
"In working group 4 of CONNECT, one of the points addressed is the need for RWD for clinical decision making and new reimbursement models for precision cancer medicine. When the patient numbers in trials are small, it is important to understand what data needs to be collected, and how RWD can supplement the clinical data in a potential evaluation process," said Strand Festervol
"A close dialogue between companies, regulatory authorities, registries and those conducting the trials is important to increase understanding and secure collection of the right parameters to build as high-quality data set as possible. In this meeting we learned learned from two experts and look forward to build on this discussion," continued Strand Festervoll.
You can access the video of the two presentations below. CONNECT partners can access the slide decks via TEAM or reach out to Jutta Heix (jh@oslocancercluster.no).