Fundamentals of Research in Imaging and Theranostics – Part 1: Research Design

COURSE CONTENT

This online course is part of a long line of research methodology which is aimed at providing interested participants with information about the preclinical development and clinical translation, as well as the design, conductance and reporting of clinical research trials, with a specific emphasis on radiopharmaceuticals for both diagnostic and therapeutic applications.

These first two modules will represent part one of the course, which will take place in 2022.

Module 1 will focus on the entire path from preclinical development to clinical translation of an imaging compound, including the preclinical studies needed for the selection of a new candidate for clinical translation, an overview of EU legislation on radiopharmaceuticals for diagnosis and therapy, and the assessment of quality data and non-clinical data (pharmacology, dosimetry and toxicology) for the IMP dossier.

Module 2 will be focused on the design of a proper trial. It will cover: the definition of objectives, aims, endpoints, population, statistical methods and examples of trial design schemes, as well as dosimetry as far as healthy organs and in case of therapy tumour-absorbed dose. It will have a special focus on phase 0, phase 1-2 trial, early clinical phase 0-1-2 and investigator-driven clinical trial.

LEARNING OBJECTIVES

The participants will learn about:

• Preclinical development and clinical translation of radiopharmaceuticals
• The legislation on radiopharmaceuticals with a specific focus on the European scenario
• Requirements of IMPD for radiopharmaceuticals for imaging agents and theranostic/therapeutic molecules
• Interpretation of preclinical data to properly design and plan the clinical trial
• Phase 0, phase 1 and phase 2 clinical trials with radiopharmaceuticals design
• Phase 0, phase 1 and phase 2 clinical trials with radiopharmaceuticals conductance
• GMP, GLP and GCP principles
• Importance of radioprotection and dosimetric estimates in early phase clinical trials

TARGET AUDIENCE

Researchers, scientists, nurses, pharmacologists, radiopharmacists, residents and specialists in Nuclear Medicine/Oncology/Radiology who want to understand how clinical trials with radiopharmaceuticals in the early phase are unique and how the corresponding documents and trial design should be appropriately planned.

PREPARATORY MATERIAL

No preparatory material.