All About Clinical Trials

Acces the course

Online platform

Access restricted to registered participants only, please note registration remains open until end of course 17 december 12:00 PM CET.

Registration

Registration fees

* Individuals must be a member of the ESC WG CVP at the moment of registration in order to benefit from the member fee

** Applies to students, trainees, nurses: proof of status will be required (letter from University, etc)

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Join the ESC Working Group on Cardiovascular Pharmacotherapy: apply now!

You will be redirected to an external website managed by our technical partner, Barcelo Congresos. For any questions or queries, please do not hesitate to contact us: workinggroups@escardio.org

Learning objectives

Reduction of cardiovascular disease burden by pharmacotherapy is a multistep approach, which requires:

• the identification of new potential drugs;
• testing new potential pharmacological compounds in a trial setting;
• regulatory approval;
• implementation of therapies in clinical practice.

The specific aim of the All About Clinical Trials course is to improve competency and confidence in:

• Designing and planning successful clinical trials;
• Evaluating and following the correct processes and regulatory procedures (GCP certificate included);
• Effectively analysing and interpreting trial data through highly interactive workshops.

Conference scientific committee

• Prof. Sven Wassmann, Germany
• Prof. Gianluigi Savarese, Sweden

Scientific programme

This programme is subject to change.

 Download the preliminary programme

Session 1. How to design and run a clinical trial

Chairperson: B. Lewis

• An overview of the different aspects of clinical trials
• Planning and running a clinical trial: site perspective
• Traditional versus novel trial designing

Session 2. Regulatory aspects

• Requirements from regulatory agencies and post-marketing surveillance

Session 3. Registries and registry-based trials

• SWEDEHEART and registry-based trials in ischemic heart disease
• SWEDE-HF and registry-based trials in heart failur

Session 4. Issues in clinical trials: the COVID-19 pandemic

• Challenges of running clinical trials in a pandemic

Session 5. Certification in Good Clinical Practice - Part I

In collaboration with AIDFM-CETERA, certificate provided

Workshops

• Workshop 1 - Statistical issues in clinical trials (Limited seats) 
  Randomised controlled trials
• Workshop 2 - Statistical issues in clinical trials (Limited seats) 
  Observational studies
• Workshop 3 - Statistical issues in clinical trials (Limited seats) 
  Systematic reviews and meta-analyses
• Workshop 4 - How to interprest clinical trial data
  Examples from clinical trials

Good Clinical Practice Certification

This course offers a certification in Good Clinical Practice (GCP) delivered by AIDFM-CETERA.

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 AACT 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.

In order to obtain the GCP certificate, registered participants must attend the full two sessions during the live meeting. GCP sessions will not be available on demand.

Feedback from previous courses

Since its launch in 2015, more than 400 participants have taken this course in clinical trials. 

• 95% of participants would recommend the course to their peers
• 65% attend the course to learn about methodology for designing and running a clinical trial
• 54% attend the course to learn statistical approaches

Testimonial

“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