All About Clinical Trials - December 2020

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 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 by highly interactive workshops.

Preliminary programme

This programme is subject to change.

SESSION 1. HOW TO DESIGN AND RUN A CLINICAL TRIAL

• 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

• Registry-based trials in ischemic heart disease
• Registry-based trials in heart failure
• Nationwide registries and cohort studies

SESSION 4. ISSUES IN CLINICAL TRIALS

• CRT trials
• ICD trials

COURSE: GOOD CLINICAL PRACTICE

• GCP for the busy investigator (certificate included)

WORKSHOPS

• STATISTICAL ISSUES IN CLINICAL TRIALS I
  Registries and meta-analyses
• CLINICAL TRIAL PARADE: WHAT´S NEXT – UPCOMING AND ONGOING CLINICAL TRIALS
  ACS / Antithrombotics
  Lipidology
  Diabetes
  Heart failure
• STATISTICAL ISSUES IN CLINICAL TRIALS II
  Randomised controlled trials and subgroup analyses
• HOW TO INTERPRET CLINICAL TRIAL DATA
  Examples from clinical trials
• THINGS TO KNOW FOR JUNIOR INVESTIGATORS
  How to write a manuscript
  Career Café: speed consultations

Venue

The course will be held in Stockholm, Sweden.

Further details will be available in May.

Registration

Registration will open in July.

Registration fees

Registration fees are inclusive of applicable local VAT.

*Further details available in July.

For any questions, please contact us on workinggroups@escardio.org

Become a member

This course is organised by the ESC Working Group on Cardiovascular Pharmacotherapy. Not member yet? Join today

Who should attend

The All About Clinical Trials courses are aimed towards clinical cardiologists and clinical pharmacologists with experience in translational and clinical research in cardiovascular drug therapy. Students or confirmed physicians, who need to improve their knowledge and clinical skills in trial management and interpretation.

Feedback from previous courses

Since its launch in 2015, more than 350 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