New Opinions And Trends In Oncology PROs: Learnings From The 2022 FDA COA In Cancer Trials Workshop

By Kelly Dumais, PhD – Principal Scientific Advisor at Clario and Jowita Marszewska, PhD – Scientific Advisor at Clario

Every year, the FDA’s Oncology Center of Excellence conducts public workshops on clinical outcome assessments (COAs) in cancer clinical trials. In June 2022, the 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop discussed the topic of using patient reported outcomes (PROs) in open-label oncology trials.

To ignite innovative thinking, the workshop brought together top leaders and patient advocates together for interactive conversations that sought to answer the industry’s most critical questions related to the use of PROs in oncology trials.

As a result of these efforts, attendees were able to gain insight into overcoming clinical trial barriers and incorporating, and so much more. “To me, the message was clear. For Oncology trials, you must use PROs to fully understand the patient experience and to better evaluate tolerability. PROs should be included as early as possible in your drug development program,” said Kelly Dumais, PhD, Principal Scientific Advisor at Clario.

Get key takeaways from the workshop by accessing the full article.