Advocate involvement in Clinical Trials: Lessons from the Patient-centric I-SPY2 Breast Cancer Trial

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Jane Perlmutter Susie Brain Thelma Brown Deborah Collyar Amy Delson Diane Heditsian Barbara LeStage Bev Parker Susan Samson Joan Venticinque Jeff Matthews


The innovative I-SPY Breast Trial is presented as an example of an unusually patient-centric clinical trial that has been significantly impacted by extensive advocate involvement. In the introduction we briefly define what we mean by patient-centric trials and describe the overall structure, goals, and evolution of I-SPY. We then describe: 1) the roles and philosophy of advocate involvement; 2) attributes of the trial design that make it especially patient-centric; and 3) educational material and communications approaches aimed at empowering and supporting trial participants. For each section, in addition to describing I-SPY practices, we provide aspirational suggestions that could enhance I-SPY and/or other clinical trials. Embedding advocates into every aspect of clinical trial design and operations, empowering trial participants with excellent patient educational material and incorporating and learning from patient-reported outcomes serves as a model approach to achieve more patient-centric clinical trials.

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PERLMUTTER, Jane et al. Advocate involvement in Clinical Trials: Lessons from the Patient-centric I-SPY2 Breast Cancer Trial. Medical Research Archives, [S.l.], v. 11, n. 7.2, july 2023. ISSN 2375-1924. Available at: <>. Date accessed: 22 july 2024. doi:
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