DISCOVER THE PROGRAMME

Complex Clinical Trials (CCTs) have the potential to accelerate drug development and enable patients to get timely access to transformative therapies. The main objective of this workshop is to develop shared solutions by:

• What is CCT – simplifying and standardising definition of CCT
• Why CCTs – how CCT can accelerate drug development
• Discussing CCTs challenges and potential solutions with stakeholders experts (regulators, HTA bodies/payers, academia, patients’ organisations and industry)  through shared experience with CCTs
• Identifying emerging best practices to facilitate the use and acceptance of CCTs
• Defining an action plan to gain acceptance of CCTs supporting regulatory decision-making
• Defining educational needs on CCTs across all stakeholders
• Discussing global implications of CCTs; Identifying opportunities and unique differentiation factors for conducting CCT in Europe (e.g. CTIS)
• Discussing interaction/synergies with existing initiatives, e.g., IMI EU-PEARL, CTTI.

The hands-on workshop format features use of case examples and interactive sessions to facilitate co-creation of solutions and active contribution by participants.

EVENT REPORT

Over 400 participants joined this interactive workshop, organised by EFPIA in cooperation with other stakeholders including regulators, ethics committees, HTA Bodies, patient representatives, clinical research organisations and clinical trial investigators. Thanks to highly interactive sessions, the participants eventually enhanced their understanding of complex clinical trials. Various recommendations were identified to address some of the challenges in designing and conducting CCTs, and more work will be needed to deliver solutions.

Attendees for this workshop have been selected from the following stakeholder groups who registered for the workshop and who had experience and/or expertise in CCTs:

• Industry and academic clinical trial researchers, for example clinicians, statisticians, and regulatory scientists
• Representatives from patient advocacy groups
• Members of Ethics Committees and National Competent Authorities
• Representatives from regulatory agencies, HTA bodies and healthcare institutions
• Members of non-profit organisations and collaborative groups with CCT related initiatives
• Members of Industry/Academic Associations

Organising Committee

• Josse R Thomas (BAREC)                                              
• Frank Bretz (EFPIA-Novartis)
• Olga Kholmanskikh (CTFG-FAMHP)                 
• Solange Corriol-Rohou (EFPIA-AstraZeneca)
• Stephane Lejeune (EORTC)                                 
• Lucia D’Apote (EFPIA-Amgen)
• James McCormick  (ACRO-PPD)                          
• Christine Fletcher (EFPIA-GSK)
• Pierre Omnes (ACRO-Syneoshealth)                  
• Mireille Muller (EFPIA-Novartis)
• Ruediger Pankow (ACRO-Parexel)                     
• Emmanuel Pham (EFPIA)
• Claas Roehl (NF Patients United)                       
• Nick Sykes (EFPIA-Pfizer)
• Anja Schiel (EMA SAWP, NoMA)                        
• Andreea Iordache (EFPIA Secretariat)
• Elke Stahl (CTFG-BfArM)                                      
• Silvia Garcia (EFPIA Secretariat)