Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL27: Statisticians Impact to Patients: Novel Drug Development for Regulators and Developers (300861)

*Catherine Njue, Health Canada 
*Melanie Poulin-Costello, Roche 

Keywords: Personalized Healthcare, real world data, patients, clinical trial design, adaptive designs

Room: Wilson A

Drug development is evolving as genetics, technology and innovation move us closer and closer to personalized health care. Regulators and innovative drug developers are adapting to this dynamic environment.

As we continue to keep our focus on the patient, the patient’s needs, and the patient’s safety, one element of novel drug development involves straying from the traditional randomized clinical trial to include novel designs such as adaptive designs, basket and umbrella trials. These novel approaches to drug development require statisticians both within regulatory and innovative drug development capacities to be creative. Statisticians, in partnership with clinical colleagues, can be the driving force in this age of personalized drug development.

Questions for discussion include: What skills do statisticians need to further drive innovation to move effective medicines to the patient faster? Are we balancing when novel vs. traditional approaches should be used? How do we adequately equip statisticians, regulators and other data scientist peers to not only consider and implement novel strategies and real world data but to communicate them to our non-statistical colleagues? What can statisticians who impact patients’ health do differently in this age of genetics and personalized health care?