Med Res Arch
11 (7.2)

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

Perlmutter J, Brain S, Brown T, Collyar D, Delson A, Heditsian D, LeStage B, Parker B, Samson S, Venticinque J, Matthews J.

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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