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1st EBMT Master Course on Clinical Research in HCT and Cellular Therapies

Date:
-
Event type:
Educational Meeting
City:
Naples
Country:
Italy
Organisers:
Antonio M. Risitano, Krzysztof Kałwak, Ali Bazarbachi, Annalisa Ruggeri, Simona Iacobelli, Isabel Sánchez-Ortega
Antonio Risitano
Antonio M. Risitano

What drives the continuous evolution of transplantation and cellular therapy?

Key Learning Objectives

1. Advanced Clinical Trial Methodology & Protocol Design

Master the complexities of designing high-quality clinical trials specifically tailored to the rapidly evolving fields of transplantation and cellular therapies. Participants will gain deep insights into innovative trial designs (including adaptive and platform trials), rigorous endpoint selection (e.g., graft-versus-host disease-free survival, long-term toxicities), and advanced statistical frameworks. 

The focus will move beyond basic concepts to address the specific challenges of designing prospective studies, retrospective registry-based analyses, and non-interventional studies in rare patient populations.

2. From Concept to Implementation: Lessons from EBMT Collaborative Trials

Translate theoretical methodology into practical knowledge by analyzing specific case studies of clinical trials and registry-based projects conducted within the EBMT. 

Participants will examine the entire trajectory of these studies, focusing on the practical challenges faced during execution—such as patient recruitment strategies, data harmonization across multiple centers, and protocol amendments. 

By learning from these concrete experiences, participants will identify the key factors that enable a multicenter collaborative study to successfully impact clinical guidelines.

3. Institutional Operations & The Complete Lifecycle of an EBMT Study

Gain a comprehensive understanding of the operational, regulatory, and logistical machinery required to run an international collaborative study.

Participants will interact directly with EBMT institutional personnel (including data managers, statisticians, regulatory experts, and study coordinators). This objective ensures that future investigators understand the entire lifecycle of a project within the EBMT ecosystem: from the initial submission of a study proposal to the Working Parties, through data collection, quality control, ethical clearances, and up to the final data presentation.

4. Strategic Fund Raising, Grant Exploitation & Consortia Building

Acquire the strategic skills necessary to secure financial resources and institutional backing for competitive research. This objective covers the global funding landscape, teaching participants how to identify and apply for educational grants, European public funding, industry partnerships, and academic foundation grants. 

Beyond simple grant writing, participants will learn how to structure a realistic research budget, pitch ideas effectively to stakeholders, and leverage international networks to build robust collaborative consortia required for high-budget multicenter trials.