The European School of Multimodality Imaging & Therapy (ESMIT)

Fundamentals of Research in Imaging and Theranostics Part 2
2025-03-01 08:00 - 2027-03-30 17:00 (Europe/Vienna)
UEMS EACCME has granted the accreditation of 4.5 CME credits for this event.

This online course is part of a longer 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.

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Learning Objectives

For phase I/II clinical studies with radiopharmaceuticals to understand:

The principles of technical realisation of the study including assessment of safety of investigational medicinal product

The statistical considerations, including the estimation of number of subjects to be enrolled

The regulatory requirements for performing clinical studies with radiopharmaceutical with special focus on diagnostic radiopharmaceuticals and to summarise the particularities of these studies

The ethical and medical considerations in common and vulnerable populations

The principles of preparing the clinical study protocol

The objectives, endpoints and outcome measures

The principles of patient selection, inclusion and non-inclusion criteria

The principles of establishment of the standard of truth, the role of the comparator, superiority/non-inferiority/equivalence(?) studies) & practical examples

Target Audience

Personnel involved in designing and/or performing phase I/II clinical research with diagnostic radiopharmaceuticals (e.g. nuclear medicine physicians, pharmacists, physicists, nurses, technologist, administrative staff).

Personnel involved in assessment of the ethical, medical and methodologic aspects of phase I/II research protocols with diagnostic radiopharmaceuticals.

All professionals interested in phase I/II clinical research with diagnostic radiopharmaceuticals

Faculty

Chiara GranaSpeaker

Bart de KeizerSpeaker

Caroline StokkeSpeaker

Jean-Noel TalbotSpeaker

Luisa Roldao PereiraSpeaker

John Andrei IagaruSpeaker

Sona BalogovaSpeaker
