What is the CVCT Workshop?

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). 

FORMAT

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.

PROGRAM

The CVCT 2019 Workshop program is not released yet. Read past years programs here.

ARCHIVES

Consult the history of the CVCT Workshop here.