Critical Challenges to the Management of Clinical Trial Imaging: Recommendations for the Conduct of Imaging at Investigational Sites.

RATIONALE AND OBJECTIVES

Participation in clinical research can be both highly rewarding and logistically demanding. As highlighted by recent Food and Drug Administration guidance, imaging has become an integral part of this research. The unique technical and administrative aspects of clinical trial imaging may differ substantially from those of standard-of-care imaging and thus burden the established clinical infrastructure at investigational sites. Failure to comply with requirements can lead to unusable data, repeat imaging, or the removal of patients from the trial. It is therefore imperative that all stakeholders address these challenges to engage in clinical research successfully.

MATERIALS AND METHODS

The authors' experiences in managing clinical trial imaging requirements at their institution were used to identify common challenges. The impact of these challenges was assessed from an operational perspective.

RESULTS

Although contract research organizations attempt to minimize these challenges, their efforts are necessarily limited and insufficient, and there is a lack of infrastructure available at investigational sites to address these issues. As such, recommendations are proposed for addressing these challenges at institutional and industry levels.

CONCLUSION

The challenges associated with clinical trial imaging require an investment of resources from all stakeholders. Investigational sites must confront these challenges to satisfy trial requirements effectively, maintain a superior level of patient care, and guarantee trial integrity. Similarly, sponsors must acknowledge the burden of clinical trial imaging and support the development of the necessary local infrastructure. The implementation of the recommendations described here will improve the conduct of clinical trial imaging.