Fundamentals of Research in Imaging and Theranostics – Part 2

This course is a continuation of Fundamentals of Research in Imaging and Theranostics – Part 1: Research Design.

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.

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

• 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, Randomisation? 
• 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  

• 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