All About Clinical Trials - EuroCVP 2019

Course directors

Sven Wassmann, MD, PhD, FESC
Gianluigi Savarese, MD, FESC

Post event resources

• Welcome, introduction and course objectives: S. Wassmann, G. Savarese
• The ESC Working Group on Cardiovascular Pharmacotherapy - Perspectives of a Past-Chairman and Editor-in-Chief: S. Agewall

SESSION 1. HOW TO DESIGN AND RUN A CLINICAL TRIAL

• An overview of the different aspects of clinical trials: G. Savarese
• Planning and running a clinical trial: site perspective: B.S. Lewis
• Traditional versus novel trial designing: J. Tamargo

SESSION 2. REGULATORY ASPECTS

• Requirements from regulatory agencies and post marketing surveillance: G.M.C. Rosano

SESSION 3. REGISTRIES and registry-based trials

• SWEDEHEART and registry-based trials in ischemic heart disease: S. James
• SWEDE-HF and registry-based trials in heart failure: L. Lund
• Danish nationwide registries and cohort studies: C. Torp-Pedersen

SESSION 4. ISSUEs IN CLINICAL TRIALS: devices I

• ICD trials: F. Braunschweig

WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS I

• Registries and meta-analyses: G. Savarese

CLINICAL TRIAL PARADE: WHAT´S NEXT – UPCOMING AND ONGOING CLINICAL TRIALS

• ACS / Antithrombotics: S. Wassmann
• Lipidology: B.S. Lewis
• Diabetes: H. Drexel
• Heart failure: C. Ceconi

ISSUEs IN CLINICAL TRIALS: devices II

• CRT trials: C. Linde

WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS II

• Randomised controlled trials and subgroup analyses: A. Niessner

WORKSHOP: HOW TO INTERPRET CLINICAL TRIAL DATA

• Examples from clinical trials: S. Wassmann, Panelists

WORKSHOP: THINGS TO KNOW FOR JUNIOR INVESTIGATORS

Parallel groups:

• How to write a manuscript: A. Semb
• Career Café: speed consultations: H. Drexel

Partners

This course is organised in collaboration with the Karolinska Institutet of Stockholm, AIDFM-CETERA Portuguese Academic CRO and the Swedish Cardiac Society.

Certification in Good Clinical Practice

Each workshop participant is certified in Good Clinical Practice (GCP) after the course.
GCP is an international ethical and scientific quality standard for the design, conduct, and recording and reporting of clinical trials that involve the participation of human subjects. Anyone managing or conducting research in the National Health Service should be aware of Good Clinical Practice and evidence of GCP training is mandatory for gaining Host Site Approval for a Clinical Trial of an Investigational Medicinal Product (CTIMP).

The course provides a review of the fundamentals of Good Clinical Practice. The training is based on the International Conference on Harmonisation GCP guidelines but also introduces The Medicines for Human Use (Clinical Trials) Regulations and Amendment Regulations 2006, which have transposed the EU Clinical Trials Directive. All latest additions are included. The course gives an overview of aspects applicable to all research.

Testimonials

100% of participants would recommend the course to their peers!

“The course allowed me not only to gain a deeper insight into the complex process of organising clinical trials, but it also offered an opportunity to discuss specific methodological pitfalls and interpret the results in cooperation with professionals who represent the highest level of expertise in the field. I highly recommend the course both to experienced investigators and to young researchers, since apart from the conventional aspects of clinical trials methodology; it also presented a novel approach to run the research efficiently and successfully.” Aleksandra Gąsecka, Poland