The primary aim of Phase 1 oncology clinical trials is to determine the safety of a new treatment, and to establish the Recommended Phase 2 Dose (RP2D), which is often determined by identifying Dose-Limiting Toxicities (DLTs). While it has been repeatedly demonstrated that physicians underestimate both the severity and the social impact of patients’ symptoms, DLTs continue to be assessed essentially through clinician evaluations. Why are patient-reported outcomes (PROs) not incorporated more regularly into early-phase oncology trials to optimize the determination of RP2D and ultimately increase the chances of demonstrating a therapeutic benefit for patients in later-stage clinical evaluation?
In this webinar, Dr Frédéric Fiteni, Medical Oncologist & Oncology PRO specialist, will present an overview of current practices and describe expert and regulatory positioning regarding the incorporation of PROs in phase 1 oncology studies. Together with Estelle Haenel, Kayentis Chief Medical Officer, Dr Fiteni will address the challenges and explore in depth the advantages of adding ePROs in phase 1 oncology trials, ultimately offering an innovative perspective to advance patient-centered drug development.
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Key topics
- Adding PROs to phase 1 oncology research: current practices
- Scientific value of Phase 1 PRO data: regulatory and expert positioning
- The advantages of adding ePROs to your phase 1 oncology clinical trials
- Challenges and mitigation strategies for robust data collection
Speakers
Dr. Frédéric Fiteni
Medical Oncologist, Oncology PRO specialist
Estelle Haenel
Chief Medical Officer @Kayentis
