Oncology Clinical Trials Case Study: I-SPY 2 & OpenClinica

By Cal Collins

The I-SPY 2 trial represents a pioneering effort in the field of oncology, specifically targeting the development of personalized treatments for breast cancer. This interventional, randomized adaptive platform trial addresses the inherent complexities of oncology clinical trials, characterized by intricate designs and vast datasets. With breast cancer's significant prevalence and impact, the stakes for effective research are high. I-SPY 2 stands out as one of the longest-running platform trials, having expanded to 35 sites and engaging nearly 5,000 participants. Over its course, it has evaluated 25 therapeutic agents, several of which have achieved accelerated approval and FDA Breakthrough Therapy Designation, marking significant progress in breast cancer treatment.

A critical component of the trial's success is the robust data management facilitated by OpenClinica, which handles the trial's extensive data and complex design requirements. OpenClinica's contributions have been instrumental in streamlining the trial process, allowing for more efficient evaluation of potential therapies.