Scientific Program

Preliminary program subject to change

Monday, 3 December 2018

08:00-17:00

Registration 

Session 1: Publication and presentation of studies

 

Editorial decision making: fair or fanciful?
Sally Marshall, UK

 

An Editor’s Perspective: The Do’s and Don’ts in Clinical Trial Manuscripts
Richard DonnellyUK

  • An Editor’s perspective on  clinical trial manuscript submissions
  • A discussion of the (imperfect) processes of peer review and editorial decision-making
  • Trends & changes in publication practice; the ‘impact Factor’ game

How to write an unattractive clinical trials abstract

Coffee Break and visit the Exhibition

Session 2: Observational and real-life studies: insecure?

 

Are most pharmacoepidemiological studies data junk? Can confounding be overcome?
Philip Home
UK

 

Meta-analysis: mostly a confidence trick?
Edoardo Mannucci
Italy

  • Meta-analysis of endpoints different from the primary endpoints of the trials included: strengths and weaknesses
  • The impact of methodological choices in designing a meta-analysis: how selection criteria and statistical approaches can affect final results
  • Selective publication and selective disclosure: how systematic reviews and meta-analyses can help.

CVD-REAL: real-value or misleading?
David Fitchett,
 Canada

Lunch Break and visit the Exhibition

Session 3: Statistical issues for RCTs

 

Propensity Scores: uses and abuses
Nick Freemantle, UK

  • How do propensity scores work to enable comparisons between different treatments?
  • What are the strengths and limitations of the propensity score approach?
  • Under what circumstances can I trust propensity score analyses?

 

Hierachical testing: uses and limitations

Network analysis of clinical trials data: merits and problems
Patricia Guyot, France

  • Principles of NMA and basic steps: research question, systematic literature review, feasibility assessment, analyses
  • Possible issues in the context of diabetes: scarce versus large evidence, potential effects modifiers and outcomes of interest
  • Potential remedies: population-adjustment method, meta-regression and sensitivity analyses

Coffee Break and visit the Exhibition

Session 4: Safety and tolerability data – insensitive and overwhelming?

 

Uncommon things commonly occur:  how best to handle 1000's of SAEs
Nigel Jones, UK


Which PROM? satisfaction, quality of life, and many others
Matthew Reaney, UK

Poster session with presenters and moderators


Tuesday, 4 December 2018

08:00-17:00

Registration 

Session 5: Use of CGM in glucose-outcome studies; ensuring validity

 

What is needed to make it acceptable to regulators?

 

CGM detected hypoglycaemia: definitions, limitations and added value
Ulrik Pedersen-Bjergaard, Denmark

  • An international consensus on reporting of CGM-detected hypoglycaemia in clinical research has been reached
  • CGM may provide a complete recording of hypoglycaemic exposure including events which are not recognized by the patients
  • CGM is less accurate in the hypoglycaemic range and CGM-detected hypoglycaemia should be assessed together with SMBG-based data

 

CGM: the problem of hyper-repeated measurement and valid statistical analysis

Panel discussion

Coffee Break and visit the Exhibition

Session 6: RCTs in the medication development programme

 

What would be the manufacturer wish list?
David Ørsted, Denmark

 

A new perspective on endpoints for CVOTs in diabetes

 

Have CVOTs gone off the rails – should the paradigm change?
Francesco Giorgino,
 Italy

Panel discussion

Lunch Break and visit the Exhibition

Session 7: Data issues from big to long to clinical practice

 

Can we successfully use data from large populations and diverse datasets (big data)?
Avraham Karasik, Israel

 

Synthesizing multiple clinical trial inputs into guidelines and practice
Baruch Itzhak, Israel


Understanding legacy effects: epidemiology or metabolic
memory?

Antonio Ceriello, Italy

Coffee Break and visit the Exhibition

Session 8: Outcomes: class or individual medication effects?

 

SGT-2 blockers
Eberhard Standl,
 Germany

 

DPP-4 inhibitors

 

GLP-1RAs
Tina Vilsbøll, Denmark

Panel discussion

Congress closing