Clinical research in Nuclear Medicine: an update on good clinical practice and recommendations

Abstract

Nuclear Medicine plays an increasingly important role in clinical research, particularly in clinical trials aimed at evaluating the safety and efficacy of medications in Alzheimer's disease. This technical note aims to systematise the changes recently introduced by the "R3" update of the Good Clinical Practice (GCP) guidelines, issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), correlating them with clinical practices in the field of Nuclear Medicine.

In this context, consent by a legal representative, participant assent, consideration for the best interests of the individual, and the possibility of revoking consent appear as updated guidelines for obtaining informed consent from participants with reduced capacity or incapable of providing consent. The recommendation to create data flow diagrams at a departmental level introduces a greater focus on the principle of data traceability, allowing for a "reconstruction" of the imaging elements of a clinical trial. The risk-based approach to quality focuses on identifying and assessing risk factors throughout all phases of the clinical trial, enabling their appropriate management. Similarly, the paradigm shift that introduces flexibility to study designs and the reduction of the operational impact of study visits should be considered particularly by professionals who interact most with volunteers, such as Nuclear Medicine Technologists.

The adoption of good clinical practices and the introduction of elements related to the "R3" update in Nuclear Medicine examinations used for clinical trials are crucial for obtaining reliable and complete data, and for ensuring the well-being and dignity of participants.