San Francisco, CA
There are significant benefits to using imaging during clinical trials. Imaging in early phases can be used as a biomarker to validate a hypothesis or to make Go/No Go Decisions to further drug development. During late phases, imaging data can contribute to the potential of expedited Health Authority approval process. However, when implementing imaging technology for the first time challenges can arise. The main challenge facing clinical operation teams during clinical research is the harmonization and standardization of imaging processes and data collection.
Study teams worry about standardization while working with many different sites. They need to ensure that the study imaging protocol is followed the same way at all various sites in the world. The scanning machines need to be regularly calibrated and maintained at every site, data collection needs to be uniform, data transferred to the CRO needs to follow identical processes, and the imaging Contract Research Organization (CRO) analyzes the data as per the study protocol. The analyzed data needs to be brought in-house in a standardized way to facilitate the statistician to demonstrate statistical significance of the data: which can ultimately prove the hypothesis or support the teams to further the development of their drug.
Certain technologies lend themselves nicely to clinical trial imaging. Structural MRI, PET and CT are readily available and widely used technologies in clinical trials – offering a lot of opportunity for late stage analysis. CEST MRI and task-fMRI are more complex, not as many vendors have the capabilities to use these technologies, making them not suitable for multifaceted studies.
Many large pharmaceutical companies have all the right personnel or know the right contacts to determine what technology they need to use and where for their clinical trials. The biggest opportunity with Medical Imaging in Clinical Research is pairing smaller pharmaceutical companies with the appropriate specialty CROs. The major CROs are set up and equipped to handle most imaging needs for clinical trials. However, smaller CROs are more specialized and narrowly focused – sometimes with more advanced capabilities.
