CME 8 Session - EANM'17

(3)
Radionuclide Therapy/Radiopharmacy/Dosimetry: Clinical Trial Design for Radionuclide Therapy

Educational Objectives:
  1. Learn how to design a clinical trial in radionuclide therapy and understand the different phases ofclinical trials.
  2. Acknowledge how to choose primary and secondary end points with regard to the trial design.
  3. Acknowledge that there is the possibility of phase 0 studies in radionuclide therapy.
  4. Get familiar with specific regulatory aspects in radiopharmacy.
  5. Acknowledge that in radionuclide therapy we have the possibility to perform dosimetry which willinfluence the trial design and which has the potential to foresee or to prevent toxicity.

Summary:
Radionuclide therapy is a very dynamic field. Numerous new radiopharmaceuticals are about to enterthe field. In order to prove the effectiveness of new radiopharmaceuticals and in order to get acompound registered specific clinical trials are needed. Basically they can be conducted in ananalogous manner as e.g in chemotherapy. However the unique properties of radiopharmaceuticalsallow to perform dosimetry which in turn allows us to conduce phase 0 trials. Additionally dosimetrycan help to foresee and avoid toxicity. With regard to regulatory affairs radiopharmaceutical featuresome particularities as well which will be highlighted in this session.

Key Words:
Radionuclide therapy, clinical trial design, radiopharmacy, dosimetry
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