Conducted at the University of California – San Francisco (UCSF), I-SPY is a re-engineered approach to the management of clinical trials for breast cancer. The goal of the project was to expedite the process of prescribing the most accurate medication to the right patient at the right time. UCSF also wanted to reduce the overall cost, time and number of patients required to bring new drugs to the market. The I-SPY trial program links Phase I (I-SPY 1), Phase II (I-SPY 2) and, eventually, Phase III (I-SPY 3) to build a pipeline of new program agents (in this case, phase 2 medication for Chemotherapy) and accelerates the process of identifying a subset of high-risk breast cancer patients who will benefit from these new agents in order to get the drug to market more quickly.
UCSF, a long-time Salesforce customer, wanted to utilize Salesforce as a tool to manage patient data. Salesforce was used to onboard new patients into the trials, manage their treatments and track their progress. Additionally, any applications developed for this purpose needed to follow all compliance requirements and allow the FDA to evaluate the data.
Our strategy to help UCSF build a tool to support I-SPY included optimization of real-time data through cleaning and verifying ongoing trial metrics as well as evaluating ways to improve trial efficiency. Oktana built an application on the Salesforce Platform using Visualforce and Apex that implemented the data collection, storage, and security. Throughout the development process, data security and compliance were key concerns and we supported their implementation of HIPAA Compliance guidelines for TITLE 21 CFR PART 11 regulation. We ensured the application allowed for easy generation of reports based on the data collected and could also integrate with external healthcare systems such as EPIC and One Source.
As the trial progressed we were able to adapt the platform with increase flexibility for users and provide reporting on patient onboarding and treatment progress. UCSF I-SPY is now a highly flexible solution that enables UCSF to track patient data and provide them with the appropriate treatments rapidly and efficiently.