The Global CardioVascular Clinical Trialists Workshop is a high-level, private meeting with an exceptional expert faculty, endorsed/supported by Inserm, NHLBI, ESC Working Group on CV Pharmacology and Drug Therapy, FDA, EMEA and Duke Heart Center. CVCT Workshops have become the authoritative meeting place for cardiovascular trial principal investigators, statisticians, Pharma R&D experts and regulators from the major transatlantic agencies. Brainstorming topics include CV drugs, device and biomarker development and trial design, conduct, ethics, interpretation, approvability and implementation.
CVCT Workshop involves a limited number of participants (30-40) and includes distinguished cardiologists, clinical trialists, principal investigators and statisticians from academia as well as senior R&D pharma doctors and NIH, EMEA-CPMP and FDA doctors.
The objectives are :
To produce relevant data from controlled clinical trials that will contribute to better clinical care
To understand the problems associated with making decisions about what constitutes relevant information, how to improve clinical trials, and, as is commonly the case, how to satisfy regulatory authorities
CVCT Workshop aims to foster an international exchange of ideas – and perhaps innovative thought leadership (not the creation of guidelines nor rule-making).
CVCT Workshop is a series of workshops dedicated to discussion among experts with the aim of improving future CV treatment discovery and development and more specifically trials designs leading optimally to new therapy approval and therapeutic progress.
Format: 2 full day workshop. EMEA and FDA will be involved with the program of one full day. EMEA and FDA faculty members are invited on an individual basis to attend both days.
The Workshop is primarily oriented toward discussion among persons as opposed to lecturing to a broad audience, not all participants are speakers. Interacting and participating in the discussion as panelists is most important. Participation to the full 2 day meeting is required.
For each topic, one speaker gives a short 10 minutes presentation in order to raise specific issues related to the assigned topic and set the stage for discussion, capitalising on the expertise of the group and assuming the high level of knowledge of the attendees. Subsequently, participants in the discussion are supposed to complement the speaker’s presentation with personal views and additional issues during a very short 5 minutes presentation each. Thereafter, and for each topic, a general panel discussion may last for up to 60-90 minutes, depending on the importance of the topic
2021 Scientific Program will be announced soon
Venue of the Congress
4101 Reservoir Rd
NW Washington, DC,
To facilitate the progress of the meeting, we ask that you give your presentation to the technician in the meeting room 30 minutes before the session begins (or during the coffee breaks)
Logistic & Technical Organization
13-15 rue des Sablons
75116 PARIS - France
Tél : +33 (0)1 40 88 97 97
Fax : +33 (0)1 43 59 76 07
US Tel: +1 415 839 8874
Personal Assistant: Stéphanie GROJEAN
Fondation Force, Research and Consulting Department
2, Rue du Doyen Jacques Parisot, BP7
54500 VANDOEUVRE LES NANCY
* AP Maggioni, B Darne, D Atar, E Abadie, B Pitt, F Zannad, on behalf of the participants in the 5th CardioVascular Clinical Trialists Workshop : FDA and CPMP Rulings on Subgroup Analyses. Cardiology 2007; 107:97-102.
* R Shah, B Darne, D Atar, E Abadie, KF Adams, F Zannad, on behalf of the participants in the 5th CardioVascular Clinical Trialists Workshop : Pharmacogenomics in cardiovascular clinical trials. Fundamental & Clinical Pharmacology 18 (2004) 705-708.
* P Sleight, H Pouleur, and F Zannad : Benefits, Challenges, and registerability of the polypill. Eur H J (2006) 27, 1651-1656.
* SM Haffner, L Ruilope, B Dahlöf, E Abadie, S Kupfer, and F Zannad : Metabolic Syndrome, New Onset Diabetes, and New Endpoints in Cardiovascular Trials. Cardiovasc Pharmacol volume 47, Number 3, March 2006.
* RM Lewis, DJ Gordon, PA Poole-Wilson, JS Borer, F Zannad : Similarities and Differences in Design Considerations for Cell Therapy and Pharmacology Clinical Trials in Cardiovascular Indications. Cardiol 2008; 110:73-80.
* W Gattis Stough, F Zannad, B Pitt, S Goldstein : Globalization of Cardiovascular Clinical Research : The Balance Between Meeting Medical Needs and Maintaining Scientific Standards. Am Heart J, August 2007; 154:232-8.
* F Zannad, W Gattis Stough, JGF Cleland, NL Geller, C Torp-Pedersen, BA Kirwan, B Pitt, F Follath : Heart Failure as an Endpoint in Heart Failure and Non Heart Failure CardioVascular Clinical Trials : The Need for a Consensus Definition. Eur Heart J. 2008 Feb; 29(3):413-421.
* JS Borer, H Pouleur, E Abadie, F Follath, J Wittes, MA. Pfeffer, B Pitt, and F Zannad : Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval. Eur Heart J (2007) 28, 1904–1909.
* Borer JS, Gordon DJ, Geller NL. When should data and safety monitoring committees share interim results in cardiovascular trials? JAMA. 2008 Apr 9; 299(14):1710-2.
* J Cohn , JGF Cleland, J Lubsen , JS Borer, PG Steg , M Perelman, F Zannad : Unconventional endpoints in cardiovascular clinical trials: should we be moving away from morbidity and mortality? J Card Fail. 2009 Apr; 15(3):199-205