Clinical MRI Studies of Drug Efficacy and Safety

The use of MRI in clinical trials of drug efficacy and safety is continually increasing. This is because MRI is ideal for identifying, characterizing, and quantifying, many common soft tissue pathologies. It is safe and can be used as often as necessary in longitudinal studies enabling more robust and powerful conclusions than are often available from conventional clinical endpoints, potentially shortening trials, reducing necessary volunteer numbers, and contributing to accelerating the drug development process. Important diseases where medical needs are currently poorly met are used to exemplify the power of MRI as a biomarker provider, including arthritis, neurodegeneration, atherosclerosis, other cardiovascular diseases, multiple sclerosis, and cancer. The special considerations which the NMR scientist must give to the conduct of a clinical trial are discussed, such as ensuring compatability and reproducibility of MRI and image analysis methodology over time and between multiple scanners and sites, ensuring secure and validated data storage and transfer to the sponsor organizations, and compliance with ethical and regulatory requirements. Keywords: biomarker; arthritis; Alzheimers; atherosclerosis; cardiovascular disease