Scientific Program

Program Subject to Change


Monday, 3 December 2018

08:00-17:20

Registration 

08:50-09:00

Welcome

Ralf Baron, Germany
Elon Eisenberg, Israel
Congress Co-Chairs

09:00-10:30

Session 1: EBM, meta-analyses and beyond

09:00-09:25
What can we learn from recent meta-analyses?
Nadine Attal, France
  • Recent meta-analyses based on systematic review in pain research
  • Relevance of meta-analyses in pain research with emphasis on neuropathic pain
  • Meta-analyses versus real life management  
09:25-09:50
The Potential Role of Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials
Vishvarani Wanigasekera,
UK
  • Place of biomarkers in analgesic drug development
  • Neuroimaging techniques available for this purpose
  • Ongoing research in developing functional neuroimaging as a biomarker in detecting analgesic pharmacodynamic efficacy

09:50-10:15

Registry data - Pros and Cons
Winfried Meissner, Germany
  • What do registry data tell us?
  • Limitations of registries
  • Real world and RCTs

10:15-10:30  
Discussion

10:30-11:00

Coffee Break and visit the Exhibition

11:00-12:30

Session 2:  Design of analgesic trials. Problems and solutions I

11:00-11:25
Meta analysis of placebo effects in RCTs of polyneuropathies  
Harriet Kemp,
UK

11:25-11:50
Sensory profiling, subgroups and the impact on power calculations
Jan Vollert, UK
  • Sensory profiling can identify subgroups of neuropathic pain, which are likely covered to mechanisms of pathology
  • Trials on neuropathic pain can apply this methodology to stratify patients, as endorsed by the European Medicines Agency
  • Rationale and methods for stratified study design and power planning are ready for use

11:50-12:15

Can PRO help to stratify chronic pain patients?
Didier Bouhassira, France

12:15-12:30
Discussion

12:30-13:30

Lunch Break and visit the Exhibition

13:30-15:00

Session 3:  Design of analgesic trials. Problems and solutions II

13:30-13:55
Bed-side testing for stratification in clinical trials

Ralf Baron, Germany

13:55-14:20
Requirement of preclinical studies to properly inform go/no go decisions to go to clinical development
Emily Sena, 
UK

  • Preclinical research is at high risk of bias
  • Multi-centre studies may address many limitations in preclinical research
  • Clinical trials often have not been designed where efficacy was shown in the laboratory
14:20-14:45

Small fiber neuropathy – Clinical trial challenges and opportunities
Roy Freeman, USA

14:45-15:00 Discussion

15:00-15:30

Coffee Break and visit the Exhibition

15:30-15:50
Using QST in pharma-sponsored analgesic clinical trials: insights from recent trials
Sponsored by Medoc

15:50-16:50

Session 4:  Visceral pain

15:50-16:20 Visceral pain: inclusion criteria, assessment and pain outcomes
Katy Vincent, UK
  • Visceral pain is commonly associated with other symptoms which also need assessing in the context of a trial
  • Composite pain and symptom scores are not recommended but multiple primary endpoints are statistically challenging
  • Symptom variation/flare is common and therefore the timeframe for data collection needs to be carefully considered
16:20-16:50 Discussion
Katy Vincent, Didier Bouhassira, Ralf Baron

16:50-17:20

Oral Presentations

16:50-17:00
The Benefit of Adding Steroids to Local Anesthetics for Chronic Non-Cancer Pain Interventions; A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Harsha Shanthanna
, Li Wang, Alka Kaushal, Rachel Couban, Harman Chaudhry, Prathiba Harsha, Erica Suzumura, Edward Zhou, Varun Bhardwaj, Isabel Kim, Mohit Bhandari, James Paul, Jason Busse, Lehana Thabane, Germany

17:00-17:10
The Influence of Different Approaches in the Handle of Missing Data for the Evaluation of the Analgesia in Clinical Trial
Andrea Nizzardo
, Simona Scartoni, Bartomeu Pizà Vallespir, Monica Bertolotti, Angela Capriati, Andrea Pellacani, Italy

17:10-17:20
A Comparison of Attitudes and Beliefs Between Regular and Non-regular Users Submitting Self-reported Digital Pain and Discomfort Mappings from Home 

Maria Galve Villa, Shellie A. Boudreau, Denmark



Tuesday, 4 December 2018

08:00-16:45

Registration 

08:30-09:00

Guided Poster Walk

09:00-10:30

Session 5: Interventional treatment and postoperative pain

09:00-09:25
The never ending story of EBM behind epidural steroid injections
Elon Eisenberg, Israel

09:25-09:50
Technology (neuromodulation)
Haggai Sharon, Israel

09:50-10:15

Clinical trials in noninvasive neuromodulation: why current paradigms do not work
Luis Garcia-Larrea, France

10:15-10:30
Discussion

10:30-11:00

Coffee Break and visit the Exhibition

11:00-12:30

Session 6:  Two big hurdles: translation and placebo

11:00-11:30

How to improve translation from animals to humans
Anthony Dickenson, 
UK

11:30-12:00
Mitigating the placebo response in clinical trials - insights from recent studies
Roi Treister,
Israel
  • Recent evidence suggests that the placebo response may be effectively modulated in the context of analgesic clinical trials. 
  • For the first time, we have a conceptual model explaining why patients with larger variability of pain scores are demonstrating larger placebo responses.
  • Those subjects share similarities, and could hence be identified, and either excluded, or trained before inclusion to analgesic clinical trials. 

12:00-12:30


Discussion

12:30-13:30

Lunch Break and visit the Exhibition

13:30-15:00

Session 7:  Current Regulatory Trends in Pain Drug Development

13:30-14:15
Industry Perspective

Silke Thömmes, Germany 

14:15-15:00  
Discussion: Industry, academia, clinicians and regulation: who sets the tone in pain drug development?
Silke Thömmes, Luis Garcia-Larrea, Winfried Meissner

15:00-15:30

Coffee Break and visit the Exhibition

15:30-16:30

Session 8: New statistical methods

15:30-15:55

Study design aspects in chronic pain dose-finding trials
Lieven Kennes, Germany

  • What is MCP-Mod and what are the advantages compared to traditional dose-finding approaches?
  • Official opinions of EMA (2014) and FDA (2016) on MCP-Mod
  • Specific challenges and recommendations applying MCP-Mod in longitudinal chronic pain trials
15:55-16:20  
  • In case of missing data, the data that are analysed are not the same as the observed data, thus always affecting interpretation of results.
  • Because we increasingly compare a novel treatment to an active control instead of a placebo, sample sizes requirements are often infeasible.

  • The statistical framework we use does not yield a direct answer to the research question we have, and this has resulted in erroneous interpretation of results.

16:20-16:30  
Discussion

16:30-16:45

Congress Closing