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Clinical Trial Imaging Consortium - We Want You!

Per the recommendations of the groundbreaking manuscript "Critical Challenges to the Management of Clinical Trial Imaging: Recommendations for the Conduct of Imaging at Investigational Sites1", the Human Imaging Research Office at the University of Chicago fully supports the formation of a clinical trial imaging consortium to advocate on behalf of investigational sites. The mission of the consortium would include (1) developing standards for research imaging infrastructure, and (2) championing for the implementation of these standards at all levels.

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From Imaging, Insight
Human Imaging Research Office, University of Chicago

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Consortium Goals

Initial advocacy efforts will focus on broad cultural topics surrounding the execution of medical imaging within the clinical research industry:

1. Contract research organizations (CROs), imaging core labs (ICLs), industry consortia, and professional organizations must recognize imaging-related responsibilities in clinical trials as separate and distinct. These responsibilities should not fall to imaging technologists, radiologists, or clinical research coordinators by default but should define separate roles for dedicated "research imaging" personnel where appropriate. These stakeholders must advocate for the development of dedicated research imaging infrastructure at investigational sites.

2. CROs and ICLs must understand that the primary responsibility of imaging technologists is their clinical duties, not the execution of clinical trials. Similarly, imaging technologists are not considered engaged in research merely because they may perform imaging exams or procedures that may be utilized as part of a clinical trial. CROs and ICLs must allow non-radiologist and non-technologist research imaging personnel to assume responsibility for the integrity of imaging at investigational sites. They must recognize the viability and importance of such personnel, they must acknowledge these individuals as domain experts who can fulfill training requirements, and they should modify their infrastructure to accommodate these individuals accordingly.

3. Investigational sites must recognize the time, effort, and expertise that is required to successfully execute clinical trial imaging. Sites must invest in appropriate infrastructure and charge trial sponsors for the utilization of this infrastructure in the same manner they charge for other research-related services.

4. Trial sponsors must recognize the increasing complexities associated with clinical trial imaging and must be willing to accept the accompanying costs for the benefit of themselves, CROs, ICLs, investigational sites, and the patients who willingly consent to becoming research subjects.

5. CROs and ICLs must forward imaging manuals and related materials to investigational sites as early as possible to avoid delays in site qualification or patient enrollment. CROs should not expect sites to achieve regulatory and budgetary approval without these materials, nor should CROs insist that sites assert their adherence to imaging guidelines they have not had an opportunity to review.

For more details, please see our 2019 PINTAD presentation. We are actively seeking collaborators in our effort to establish this consortium, and we welcome your input and participation!

If you are interested in joining the HIRO in forming a consortium, please contact us at hirohelp [at] bsd [dot] uchicago [dot] edu!

References

1 Acad Radiol 2020; 27(2): 300-306, https://doi.org/10.1016/j.acra.2019.04.003