EFSPI Representation at RISW 2024 & Reflections on “Ask the Regulators” Session
Justine Rochon (Boehringer Ingelheim) on behalf of EFSPI
This past September, Mouna Akacha (Novartis), Emmanuel Zuber (Cogitamen), and I were thrilled to represent EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) at RISW 2024, thereby strengthening the connection between statisticians on both sides of the Atlantic. The collaboration between EFSPI and the ASA-BIOP section is vital to our goal of sharing knowledge, fostering innovation, and building a stronger global community!
Among many fantastic sessions, I particularly enjoyed attending the “Ask the Regulators” session. This session concluded with a powerful role play by Mouna and Emmanuel, who stepped into the shoes of a patient and a doctor, respectively. This set the stage for an engaging dialogue around the role and content of drug labels.
The following key questions were posed to the regulators:
What is the role of the label? Is it to document approval, support prescriber-patient dialogue on treatment effects, or both?
Could a structured approach, like the estimand framework, help provide prescribers with relevant, regulated information, and clarify underlying assumptions?
What initiatives are underway to enhance label content for prescribers and patients?
The regulators clarified that labels are not for documenting approval. They serve to communicate drug information in a clear and concise manner to healthcare professionals, patients, and their caregivers. The main challenge lies in balancing informativeness and accuracy without being misleading or superfluous. They also stressed the need for discussions about the label before designing the trial and the importance of active controls to better inform treatment decisions. This perspective isn't exclusive to the FDA; similar challenges exist in Europe. It was also good to hear about the ongoing initiatives to improve the labeling for prescription medicines. Finally, I highly appreciated the panel's inclusion of both statistical and medical viewpoints, highlighting the high complexity physicians face when making decisions.
The session was a remarkable success. Kudos to Zhiheng Xu and the ASA Biopharmaceutical Section workshop organizing committee for their courage to experiment and pilot this session, a practice we've been following for several years in the EFSPI Regulatory Statistics Workshop. Also, a big thank you to the regulators from the FDA and EMA for their clear responses.
Save the date! The 10th EFSPI Regulatory Statistics Workshop is set to take place from the 10th to the 12th of September 2025, once again at the Biozentrum in beautiful Basel, Switzerland. Online participation is possible, and workshop materials will be made available. For more details, see https://efspieurope.github.io/workshop/.
Lastly, I am delighted to announce that I have been elected as an 'At Large Member' of the ASA BIOP Executive Committee for the term 2025-2027. It's an honor to serve in this role and I look forward to strengthening the collaboration between EFSPI and ASA BIOP.
Let's continue this important dialogue and collaboration as we all work with the same data towards the same purpose.