UNIFORM PROTOCOLS FOR IMAGING IN CLINICAL TRIALS (UPICT) 

The ongoing UPICT work, including the UPICT template, is posted on the UPICT wiki at http://upictwiki.ctsa-imaging.org          

Resources

RSNA 2009 UPICT poster displayed in Lakeside Learning Center

The UPICT Concept:

To facilitate the development and maintenance of widely acceptable, consistent imaging protocols (including imaging quality control procedures) for use in clinical trials across a range of disease states, anatomic sites, and imaging modalities:

•  to “improve” the contribution of imaging data in clinical trials, including improved statistical power
•  while supporting robust case accrual
•  and decreasing time to study initiation / site activation
•  to facilitate image data aggregation across trials
•  to allow the development, optimization, and validation of imaging biomarkers
•  through the participation of imaging scientists and clinical trialists drawn from the broad range of interested constituencies

UPICT Goals (in part):

•  Reduce variance related to imaging in the conduct of clinical trials (early and late phase so as to support both translation and clinical indications):
      –     to allow the detection of differences that are a consequence of the intervention under study, not an artifact of the manner in which the imaging is conducted
      –    to support optimization and validation of imaging biomarkers (platforms, agents, algorithms, etc.)
•  Improve the likelihood that:
      –   clinical imaging studies obtained will comply with clinical trial protocol expectations
      –  clinical trial imaging protocols will “fit” with practice
•  Potentially provide a subtle impetus to improve standard of care (thereby increasing the chances that pre-enrollment imaging might be used as “baseline” study)

UPICT Objectives (in part):

•          Short term
      –   standard imaging protocol template(s)
      –  a web-based workspace and supporting infrastructure to facilitate the submission, vetting, and annotation of Proffered Protocols in a transparent and inclusive manner
      –  a web-based resource library of annotated Proffered Protocols that have been used to support clinical trials within institutions, cooperative groups, and trials consortia that meet a minimum set of criteria
       –  a web-based workspace and infrastructure to facilitate the iterative authoring and periodic review of Consensus Protocols in a transparent and inclusive manner
       – a web-based environment to facilitate the interaction among clinical trialists and imaging scientists within academia, industry, and agencies
•          Long(er) term
       – a web-based resource library of Consensus Protocols that have been subjected to rigorous, transparent, inclusive (yet expert) review and approval that will be updated through an ongoing process

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