The meeting will consider the importance of patient-centric input into regulatory and HTA decision-making discussing the latest developments in the field and presenting industry examples. Speakers from EMA, the pharmaceutical industry, and those working with HTAs and patients will give their perspective on the importance and practical aspects of selecting relevant for patients outcomes in the evaluation of clinical trials.
Over the course of two half days we will have a range of speakers providing insight into the process of involving patients as research partners and how Patient Preference Studies can yield deeper understanding on patients' perspectives for decision-making in clinical trials. To set the stage, we will discuss the regulatory perspective, review published guidance and existing framework, and give overview of the logistical and methodological challenges faced by researchers and HTA bodies. We will present case studies assessing the importance to patients of improving symptoms in chronic obstructive pulmonary disease and fatigue in multiple sclerosis, both using discrete choice experiments. We will learn about a conceptual framework for addressing patient preferences in dose selection in the absence of full information on risks and benefits, also involving discrete choice experiments. The event will finish with a panel discussion, where experts will deliberate on the key takeaways and future directions as well as the role of the statistician in patient-focused drug development.
Who is this event intended for? Statisticians in the pharmaceutical industry, HTAs and regulatory bodies, working with registrational clinical trials.
What is the benefit of attending? Learn about latest developments in patient-focused drug development from various stakeholders' perspective.
Timings:- Please note, this event will be split over two consecutive afternoons, the timings for which are listed below.
Wednesday 18th October: 13:00-15:40 BST
Thursday 19th October: 13:30-16:10 BST
Oct 18 & 19, 2023 (GMT+1)