SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Use of Imaging Agents in Therapeutic Drug Development and Approval

Abstract

The process of bringing a new drug to market is complex and has recently necessitated a new drug-discovery paradigm for the pharmaceutical industry that is both more efficient and more economical. Key to this task has been the increasing use of nuclear medicine and molecular imaging to support drug discovery efforts by answering critical questions on the pathway to development and approval of a new therapeutic drug. Some of these questions include whether the new drug reaches its intended target in the body at sufficient levels to effectively treat or diagnose disease without unacceptable toxicity; how the drug is absorbed, metabolized, and excreted; and what the effective dose is in humans. To conduct the appropriate imaging studies to answer such questions, pharmaceutical companies are increasingly partnering with molecular imaging departments. Nuclear medicine technologists are critical to this process, as they perform scans to collect the qualitative and quantitative imaging data used to measure study endpoints. This article describes preclinical and clinical research trials and provides an overview of the different ways that radiopharmaceuticals are used to answer critical questions during therapeutic drug development.