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, presented an overview of current practices and described expert and regulatory positioning regarding the incorporation of PROs in phase 1 oncology studies. Together with Estelle Haenel, Kayentis Chief Medical Officer, Dr Fiteni addressed the challenges and explored in depth the advantages of adding ePROs in phase 1 oncology trials, ultimately offering an innovative perspective to advance patient-centered drug development.
Dr. Frédéric Fiteni & Estelle Haenel
Medical Oncologist, Oncology PRO specialist & CMO @Kayentis
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Frédéric Fiteni, Ph.D. is a member of the Kayentis Scientific Advisory Board. He is a medical oncologist and oncology PRO specialist at the University Hospital of Nîmes – France and a lecturer at the University of Montpellier – France. Frédéric specializes in the treatment of breast and gynecological cancers. He holds a Ph.D. in methodology-biostatistics, focusing on statistical models for quality-of-life (QoL) analysis in oncology clinical trials. He continues his research on QoL models as well as supportive oncology care and clinical research in onco-senology and onco-gynecology.
Joined Kayentis as Chief Medical Officer in 2019. Estelle drives the scientific strategy of the company, collaborating with the scientific advisory board and focusing on patient and site engagement. She has 25+ years of experience in pre-clinical and clinical research in Top 5 Pharma and Biotech companies. A Doctor of Pharmacy, Estelle also has a Masters in Endocrinology and Cellular Interaction and a PhD in Biochemistry and Molecular Biology.
Learn more in our white paper:
“ePRO in early phase oncology trials: A revolution on the horizon”
