Various classes of antidiabetes drugs are currently available that have differential drug effects. Current clinical T2D guidelines favour drugs with demonstrated clinical benefit and well known safety profiles, but do allow some degree of personalized treatment. The main goal of antidiabetic treatment is to achieve normo-glycemia without serious high or low blood glucose levels to prevent or delay the onset and progression of diabetic complications. Factors to be considered include efficacy, age, potential side effects, weight gain, comorbidities, hypoglycemia risk, costs and patient preferences (see also ProminenT Denig program). Further, recent research shows that collecting evidence-based information based on individual patient preferences in the context of favourable and unfavourable effects is feasible and useful and could guide to a more patient-centered value judgement of pharmacological agents and thus contribute to a more transparent communication on how the patient views have been incorporated in the regulatory decision making. However, these findings have not been systematically evaluated and translated back into the drug approval process. Moreover, while regulators evaluate carefully drugs’ various effects these are not quantitatively weighted. Finally, how evidence on individualized / personalized treatments should translate back into the regulatory decision-making is largely unknown.
This project aims to study, from a regulatory perspective, how elicited patient preference information can be combined with clinical trial data to estimate the acceptability of various classes of antidiabetes drugs currently available that have differential drug effects. Questions may include:
- What are the most relevant treatment related attributes with regards to glucose-regulating medicines’ favourable and unfavourable effects from a patient, HCP and regulator perspective?
- What is the current available knowledge in terms of comparative efficacy and safety of various antidiabetic medication therapies in patients with Type 2 DM not adequately controlled on stable and optimized metformin monotherapy.
- What glucose-regulating medicines meet which stakeholder’s preferences?
- How can known (or new) drug effects be translated more efficiently to patients and HCPs?
- How can patient preferences and individual patients’ needs be fed back into the regulatory decision-making? And is this needed?