REAL WORLD DATA AND SHARED DECISION MAKING: NAVIGATING THE INTERSECTION OF QUALITY, COST AND SURVIVAL

Scientific research in oncology has led to very significant changes, particularly in the area of breast cancer, in terms of response to treatment and improved clinical outcomes for patients. Although randomised controlled trials (RCTs) remain the research modality most relied on by regulatory authorities to establish the safety and clinical efficacy of drugs, evidence from the socalled 'real world' of clinical practice outside trials (real world evidence - RWE) is currently playing an increasingly important role as a valuable component for the evaluation, theoretically both 'pre' and 'post' regulatory approval.
RWD refers to analysis derived from prospective and/or retrospective data routinely collected in the course of actual clinical practice.
Although RWE is not a substitute for RCTs, it is certainly a useful tool for supplementing efficacy and safety data from registration studies. Therefore, important resources must be used to standardise the quality of RWE and validate its use, so that it can be integrated with RCTs to provide unique insights into patients, treatments and outcomes in routine oncology practice.
RWD could play an instrumental role in what is called Shared Decision Making (SDM), i.e. decision-making that actively involves patients in treatment choices, making them aware of different options and the evidence supporting them. SDM and RWE would, therefore, be tools that contribute to enrich clinical practice and improve patients' care pathways.
The course will provide an overview of RWD and SDM, particularly in the context of breast cancer.

WEBINAR diretta zoom - 13 Gennaio 2025
dalle ore 14.00 alle ore 17.30

Il test di valutazione ed il modulo di qualità percepita saranno disponibili al termine del webinar e
dovranno essere compilati entro il 16/01/2025

PROGRAM

Introduction and Course Objectives – C. Criscitiello, M. Di Maio
Session I: Advancements in Real-World Evidence
Moderators: Giuseppe Curigliano and Mario Giuliano
ore 14:00  Exploring the Evolution of Real World Data (RWD) and Evidence (RWE); the AIOM point of view – Francesco Perrone
ore 14:20  RWE Insights: A Statistical Analysis Perspective – Alessio Signori
ore 14:35  The value of RWD for scientific societies and regulators: are the rules changing? – Antonis Valachis
ore 14:50  Discussion
Session II: Innovations and Future Outlook in Real-World Studies
Moderators: Massimo Di Maio and Giampaolo Bianchini
ore 15:00  Implementing Next-Generation Real-World Studies – Emilio Bria
ore 15:15  Impact of RWD on Clinical Practices: A Case Study in Metastatic Breast Cancer – Andrea Botticelli
ore 15:30  Data Sharing in the Modern Era: Case Studies and Models – Claudio Vernieri
ore 15:45  Discussion
Session III: Enhancing Patient Care through Shared Decision Making
Moderators: Carmen Criscitiello and Grazia Arpino
ore 16:00  Quality of Life and Oncology: Measuring the Impact of New Therapies – Carmine De Angelis
ore 16:15  The Significance of Patient-Reported Outcomes in Healthcare – Massimo Di Maio
ore 16:30  Round Table: Optimizing the Shared Decision-Making Process in Patient Care
              . Patient Perspective - Rosanna D’Antona
              . Physician Perspective – Grazia Arpino
              . Psychologist Perspective - Gabriella Pravettoni
ore 17:05  Q&A
ore 17:20  Summary and Concluding Remarks by Scientific Directors
ore 17:30  Webinar Closure

Per la fruizione e l'accesso al corso FAD saranno necessari un computer (Windows o Mac) dotato di connettività internet, di un browser di navigazione standard (Internet Explorer, Firefox, Chrome, Opera, Safari) e di un programma per l'apertura e la lettura dei file PDF (per esempio: Adobe Acrobat Reader).
Per la fruizione della diretta sarà necessario installare il programma gratuito ZOOM, Potete effettuare il download del programma, e le relative istruzioni di installazione su https://zoom.us/download 

Durante il webinar in diretta, i Discenti avranno la possibilità di accedere con video-camere e audio attivi per partecipare e interagire con la faculty.
Maggiori informazioni tecniche verranno fornite durante la diretta.

Questionario (obbligatoriamente a risposta multipla) DA COMPILARE ENTRO IL 16/01/2025

Attenzione: la nuova normativa ministeriale in vigore dal 01/07/2019 prevede che:

• soglia di superamento: 75% delle risposte corrette

L’assegnazione dei crediti formativi è subordinata alla partecipazione effettiva del programma e al superamento della verifica di apprendimento.