Built on the I-SPY network — streamlining the path from molecule to evidence for breast cancer therapeutics.
The Pre-I-SPY Program is built on the I-SPY network, with the overall aim to streamline the process of design, regulatory pathway, contracting, activation, enrollment, execution, data gathering and analysis, as well as reporting of new therapeutic agents or combinations of relevance to breast cancer.
The I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms to be subsequently added as new protocol appendices through amendments to this master protocol. Selected agents or therapeutic combinations are tested through this protocol in I-SPY network centers that participate in the Pre-I-SPY Program.
The master protocol, appendices (new drug regimen arm implementation plan), informed consents (ICFs), contracts, electronic case report forms (eCRFs), Data Monitoring Committee (DMC) activities, regulatory processes, site initiation visit (SIV) materials, and sample collection plans are templated. The aim is to achieve uniform, predicted milestones, less wasted effort from chaperone, investigators and team, and ultimately rapid study activation, execution, analysis, and reporting.
