Scientific Program

Program subject to change

Monday, 3 December 2018

08:00-17:00

Registration 

08:30-08:40

Chairman's introduction

08:30-08:40

Philip Home, UK

08:40-10:00

Session 1: Publication and presentation of studies
Chair:
 Philip Home, UK

08:40-09:05

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

  • The editorial process should result in work being presented in the best possible way, in a paper which is exciting, novel, easily assimilated, internally consistent, balanced and appropriately detailed
  • Avoid antagonising editors and referees
  • Post-acceptance, pre-publication checks enhance the validity of the work

09:05-09:30

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

09:30-10:00

Panel Discussion: Getting clinical trials into the public domain: need to change the paradigm?

Sally Marshall, Richard Donnelly, Eberhard Standl

10:00-10:30

Coffee Break and visit the Exhibition

10:30-12:00

Session 2: Observational and real-life studies: insecure?
Chair: Sally Marshall, UK

10:30-10:55

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

11:00-11:25

CVD-REAL: real-value or misleading?
David FitchettCanada

  • Observational clinical trials such as CVD Real can provide useful information about outcomes in a wider population than studies in RCTs
  • Confounding can never be eliminated in observational studies and likely explains the differences observed between outcomes observed in CVD Real and the RCTs of SGLT2 inhibitors.
  • Observational studies provide guidance especially in the recognition of infrequent adverse events but rarely should be used to change practice or initiate a new treatment strategy.

11:30-12:00

Panel discussion: How can we make observational trials contribute more than hypothesis setting?

Philip Home, David Fitchett, Edoardo Mannucci

12:00-13:00

Lunch Break and visit the Exhibition

13:00-14:30

Session 3: Statistical issues for RCTs
Chair: Francesco Giorgino, Italy

13:00-13:25

Propensity Scores: uses and abuses
Nick FreemantleUK

  • 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?

13:25-13:50

Meta-analysis: mostly a confidence trick?
Edoardo MannucciItaly

  • 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.

13:50-14:15

Network analysis of clinical trials data: merits and problems
Patricia GuyotFrance

  • 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
 
14:15-14:30

 Discussion

14:30-15:00

Coffee Break and visit the Exhibition

15:00-16:30

Session 4: Safety and tolerability data – insensitive and overwhelming?
Chair: Richard Donnelly, UK

15:00-15:25

Uncommon things commonly occur:  how best to handle 1000's of SAEs
Nigel JonesUK

  • A trial sponsor’s view on detecting safety signals in large clinical trials which can accrue thousands of SAEs
  • Sifting away the background noise – graphical and numerical aids
  • Coping with more comparisons than conventional multiplicity adjustment can handle

15:30-15:55

PROMs and PREMs: Finding the right tools
Jörg Huber, UK

  • Patient reported outcome measures (PROMs) and more recently patient reported experience measures (PREMs) are central to patient-centred medicine and healthcare.
  • The plethora of tools and measures can be bewildering.
  • The question of what we want to measure, i.e. the validity of the measure, and practicalities need to inform the choice of tool.

16:00-16:30

Panel discussion: Outcomes that matter to people with diabetes

Nigel Jones, Jörg Huber, Sally Marshall



Tuesday, 4 December 2018

08:00-17:00

Registration 

08:30-10:00

Session 5: RCTs in the medication development programme
Chair: Baruch Itzhak, Israel

08:30-08:55

Have CVOTs gone off the rails – should the paradigm change?
Francesco GiorginoItaly

09:00-09:25

What would be the manufacturer wish list?
David ØrstedDenmark

09:30-10:00

Panel discussion
Francesco Giorgino, David Ørsted, Nigel Jones

10:00-10:30

Coffee Break and visit the Exhibition

10:30-12:00

Session 6: Issues in clinical trial design
Chair: Eberhard Standl, Germany

10:30-10:55

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

  • 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

11:00-11:25

Understanding legacy effects: epidemiology or metabolic memory?
Antonio Ceriello,
Italy

11:30-12:00

Panel discussion Design issues in clinical trials
Ulrik Pedersen-Bjergaard, Antonio Ceriello, Tina Vilsbøll

12:00-13:00

Lunch Break and visit the Exhibition

13:00-14:30

Session 7: Data issues from big to long
Chair: Edoardo Mannucci, Italy

13:00-13:25

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

13:30-13:55

Synthesizing multiple clinical trial inputs into guidelines and practice
Baruch ItzhakIsrael

14:00-14:30

Panel discussion: Optimal data translation: is it beyond us?
Avraham Karasik, Baruch Itzhak, David Ørsted

14:30-15:00

Coffee Break and visit the Exhibition

15:00-16:30

Session 8: Outcomes: class or individual medication effects?
Chair: TBC

15:00-15:25

SGT-2 inhibitors
Eberhard StandlGermany

  • How relevant is the heterogeneity of the primary MACE outcome across trials?
  • How consistent is the reduction of hospitalization for heart failure across trials?
  • Is the increased risk of lower limb amputation a drug specific side effect?

15:25-15:50

DPP-4 inhibitors
Richard Carr,
UK

15:50-16:15

GLP-1RAs
Tina Vilsbøll, Denmark

16:15-16:30

Panel discussion Class effects: will we ever know?
Eberhard Standl, Richard Carr, Tina Vilsbøll

16:30

Congress closing & Best Abstract Awards
Philip Home, UK