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29 January 2021

Info Sheet: Imaging Protocol Development

Written by The Bracken Group

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Leverage The Bracken Group’s experience and expertise to develop protocols with imaging that
will support efficient, effective research.

Few internal teams in biopharma have the expertise required to develop a strong protocol in which medical imaging is a key endpoint. At The Bracken Group (TBG), we do. Our subject matter experts are valuable resources for . . .

• Scientific and translational biomarker teams looking to identify appropriate imaging biomarkers.

• Clinical teams planning and developing studies.

• Operational teams working on implementation.

• Statisticians tasked with powering and SAP development.

• Designing protocols that minimize patient burdens and reduce potential dropouts.

• Identification and selection of appropriate imaging endpoints that are fit for purpose.

This includes:

    • Researching available endpoint options.
    • Advising, based on the level of validation, which imaging biomarkers are fit for purpose.
    • As necessary, proposing preliminary imaging biomarker work to avoid potential implementation, validation, or variability issues with biomarkers.
    • Advising on techniques for ensuring imaging biomarkers can be implemented
      robustly for multi-center trials.

Work with TBG to ensure...

  • Appropriate endpoints are selected.
  • Endpoints are crisply defined to precisely inform the development of powering calculations, statistical analysis plans, site surveys, and imaging review charters.
  • Optimal imaging modalities are selected.
  • Potential protocol amendments are minimized by . . .
    • Stating basic imaging equipment and facility requirements so that PIs can assess their sites’ appropriateness for study participation based on the protocol.
    • Ensuring any potential safety issues related to imaging are addressed for IRB review.
    • Including language for the IRB to assess that the imaging will be done with appropriate quality (such as central review).
    • Leaving the imaging details out but referencing that they will be made available in study specific documentation.
    • Ensuring in advance that the endpoints are appropriate and analyzable.
    • Ensuring that the protocol identifies the potential for the data to be used in other ways after appropriate de-identification.

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