The Next Frontier In Early Phase Oncology Trials

In an opening keynote session at the Clinical Outsourcing Group New England meeting on April 23, 2024, Erin Finot, Vice President of IQVIA Biotech, provided valuable insights into the next frontier of early phase oncology trials. Erin highlighted several key strategies and tools that can optimise study protocols and enhance patient diversity in oncology clinical trials.

One of the main takeaways from the presentation was the importance of leveraging AI and analytics to pressure test protocols through IQVIA's Design and Interpretation Protocol Assessment (DIPA) service. By integrating medical, operational, and analytical expertise, DIPA helps validate design decisions, identify potential study risks, and minimise patient and site burden. Erin shared that this approach has led to significant reductions in protocol amendments and time savings of 1-3 months.

Erin also discussed the FDA's Project Optimus initiative, which aims to reform the dose optimisation and dose selection paradigm in oncology. She emphasised the need for new dynamic strategies that leverage nonclinical and clinical data to maximise the efficacy, safety, and tolerability of drugs. Selecting the right sites and investigators, along with addressing patient concerns through effective communication, were highlighted as crucial factors in the success of early phase oncology trials.

Another key focus of the presentation was the importance of patient diversity and inclusion. With the recent signing of the DEPICT Act into law, Erin outlined the upcoming requirements for Diversity Action Plans in clinical trials. She provided a proactive approach to achieving clinical trial diversity, which includes reflecting diversity in trial design, factoring in site selection, clear communication, and monitoring progress throughout the trial lifecycle.