Maximizing Value in Early Phase Oncology Trials: Innovative Endpoints for Early Insights Webinar Replay

Watch this webinar replay to learn how advanced image analysis techniques enable more sensitive and earlier detection of treatment response than conventional methods. The speakers also explore how early phase pharmacokinetic data can be leveraged in concentration-effect modeling for cardiac safety, not typically feasible in later development. The role for early patient input on tolerability, symptom burden and symptomatic adverse events in strengthening clinician assessments and supporting dose selection will also be discussed.

In this on demand webinar, you will gain insight into:

• Assessing cardiac safety risks of a new oncologic agent in early phase clinical trials can be achieved with minimal impact on development cost and complexity. Speakers will also review how the elimination of concerns for drug-induced QT prolongation during early development can simplify and accelerate later-stage development.
• Leveraging AI-powered lesion segmentation during dose escalation can facilitate the generation of additional valuable biomarkers, including total tumor burden, that may inform Phase II dose selection more effectively than RECIST alone. Panelists will also review how advanced analytical tools, such as tumor growth kinetics, may be more sensitive predictors of treatment response and progression than RECIST, during early phase development.
• Patient-reported outcomes (PROs) in early phase oncology trials provide critical insights into treatment tolerability and the patient experience, enabling a more comprehensive, patient-centered evaluation of risk-benefit profiles. The speakers will also share key highlights and recommendations from recent literature and regulatory guidances on best practices for incorporating PROs in oncology trials.