Ateneo - UPO

Ecco la traduzione in inglese del testo, mantenendo il registro tecnico e formale tipico del settore regolatorio e farmaceutico:Clinical trial design from a regulatory perspectiveThe transition from "science" to "regulatory"Choice of study designPopulation selectionComparatorsEndpointsThe drug registration process and regulatory agencies:The regulatory landscapeEuropean registration proceduresFast-track and conditional approvalsIndirect comparisons and quality assessment of evidence (GRADE)

Lecture handoutsEPARs (European Public Assessment Reports) of drugs approved by the European Medicines AgencyScientific literature

By the end of the module, students will be able to:
• Understand the methodological requirements that transform a clinical trial into a "regulatory dossier".
• Navigate the approval processes of regulatory agencies (EMA, AIFA).
• Critically evaluate the quality of scientific evidence and understand the role of indirect comparisons.

Attendance of the second-year course in Economics and Management of the Pharmaceutical Industry

The course combines lectures and active learning activities.
Innovative teaching activities will include:
• analysis and discussion of a clinical trial/EPAR from a regulatory perspective
• group work
• flipped classroom

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The assessment will be carried out in two phases: (1) a multiple-choice test to evaluate the knowledge learned in class; (2) the evaluation of group work analyzing a real-world case of a recent drug approval, identifying the limitations of the study design and the certainty of evidence according to the criteria discussed.

The module will cover three macro-topics:
1) Clinical trial design from a regulatory perspective: we will examine how a clinical trial is designed, analyzing when and how to choose the type of study (superiority, equivalence, non-inferiority), the population (inclusion/exclusion criteria, internal vs. external/real-world validity), the comparators (placebo vs. standard of care: ethical and methodological implications), and primary and secondary endpoints. Clinical trial design will be addressed from the perspective of regulatory bodies.
2) The drug registration process and regulatory agencies: the focus will be on the various players in the regulatory process, specifically distinguishing the roles of EMA and AIFA. European registration procedures (Centralized, Decentralized, Mutual Recognition, and National) will be analyzed, with particular attention to fast-track and conditional approvals (Priority Medicines (PRIME), conditional marketing authorization, and unmet medical needs).
3) Indirect comparisons and quality assessment of evidence (GRADE): indirect comparisons and Network Meta-Analyses (NMA) will be introduced. A key focus will be the GRADE system (Grading of Recommendations Assessment, Development and Evaluation), analyzing the pillars of this assessment (risk of bias, inconsistency, indirectness, imprecision, and publication bias) and how the certainty of evidence is graded (High, Moderate, Low, Very Low).

1) critical reading skills for clinical trials; 2) ability to understand the methodological differences between the clinical/scientific perspective and the regulatory perspective; 3) acquisition of basic knowledge regarding regulatory bodies and guidelines for clinical trials.