Reality Check: Are We Bridging the Evidence Gaps for Patients?
Author(s)
Patrice Verpillat, MD, MPH, PhD, European Medicines Agency (EMA), Amsterdam, Netherlands, Yannis Natsis, MA, BA, European Social Insurance Platform (ESIP), Brussels, Belgium, Anne Willemsen, MSc, Dutch National Healthcare Institute, Diemen, Netherlands, Almath Spooner, ., Abbvie, Dublin, Ireland and Nikos Dedes, BA, Greek Patients' Association, Athens, Attika, Greece
We, regulators, HTA agencies, payers and pharmaceutical industry, are all working closely with patients to ensure that innovative drugs can benefit patients as early as possible. This collaboration is guided by the ambition to enable and use the generation of reliable and valid evidence that will address and answer different questions, e.g. for benefit/risk assessment, for relative effectiveness assessment... We are relying on the totality of evidence generated, either from randomized controlled trials, or from other designs such as studies using real-world data. Even if differences in scope may exist, there are overlapping commonalities in what constitutes meaningful evidence generation. We also must deal with (remaining) uncertainties at different stages of decision making. How can we limit these uncertainties, and ensure that at the end of the overall approval process, all stakeholders get the needed evidence to take an informed decision and ensure an innovative drug reach the patients if appropriate?
Conference/Value in Health Info
Topic
Health Policy & Regulatory