UPICT
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:
• 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:
• 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