Data: Webinar Live, 13 gennaio 2025
Corso ECM ID: 2157- 435047 ACCREDITATO PRESSO LA COMMISSIONE NAZIONALE PER LA FORMAZIONE CONTINUA
Attribuiti 4,5 Crediti Formativi
Responsabili Scientifici: Carmen Criscitiello, Massimo Di Maio
Professioni accreditate: Medico chirurgo (Anatomia patologica, Oncologia), Biologo, Psicologo, Tecnico sanitario laboratorio biomedico.
Durata corso: 3 ore
Razionale:
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.
