@article{MRA, author = {Jane Perlmutter and Susie Brain and Thelma Brown and Deborah Collyar and Amy Delson and Diane Heditsian and Barbara LeStage and Bev Parker and Susan Samson and Joan Venticinque and Jeff Matthews}, title = { Advocate involvement in Clinical Trials: Lessons from the Patient-centric I-SPY2 Breast Cancer Trial}, journal = {Medical Research Archives}, volume = {11}, number = {7.2}, year = {2023}, keywords = {}, abstract = {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.}, issn = {2375-1924}, doi = {10.18103/mra.v11i7.2.4085}, url = {https://esmed.org/MRA/mra/article/view/4085} }