Ateneo - UPO

The course provides a comprehensive overview of clinical trials in hematology, with particular focus on studies involving leukemias, lymphomas, and multiple myeloma. It will cover principles of study design and conduct, hematologic endpoints, regulatory aspects, safety, data management, and the role of innovative technologies, with a special emphasis on topics relevant to the field of Medical Biotechnology. Throughout the course, self-assessment activities will be provided, along with supplementary materials for further study and group presentations on topics of particular interest.

The didactic material, including slides, provided by the Professor; scientific papers covered in class; and online public databases are all resources will be used in this course. translate this to italian: Linee guida ICH E6 (R3) per la buona pratica clinica (GCP); Linee guida EMA

Critically understand clinical trials in hematology; interpret protocols; evaluate endpoints; recognize the role of trials in therapeutic progress.

Knowledge of statistics, epidemiology, and research methodology; Ability to interpret Kaplan–Meier plots and major statistical analyses

A) Taught (frontal) classes with slide presentations available on the UPO DIR website (https://www.dir.uniupo.it/); B) Self-assessment tests after each class; C) Group presentations by the students on topics agreed upon with the professor

Participation in the self-assessment activitities after each class is strongly recommended

1. Written exam:• 4 True/False statements with a 5–10 line explanation• critical questions on endpoints, design, safety, and statistics2.Oral exam:•discussion of an assigned clinical trial• assessment of critical and interpretive skills3.Continuous assessment:• participation in self-assessment activities and presentations

A. Introduction to Clinical Trials in Hematology
B. Clinical Study Design
C. Hematologic Endpoints
D. Regulatory Considerations and Ethics
E. Safety and Pharmacovigilance
F. Applied Statistics
G. Advanced Technologies
H. Disease-Specific Trials
I. Role of the Clinical Trial Unit.

• Critically analyze a complex clinical protocol
• Evaluate endpoints and methodological robustness
• Interpret statistical and clinical results in hematologic settings
• Distinguish high-quality studies from methodologically weak ones
• Understand how trials guide clinical decisions and precision medicine