This meeting will focus on the latest progress in selected statistical topics of high relevance to clinical drug development.
The Scientific Committee, chaired by Pr Bruno FALISSARD from Université Paris Sud, has identified four areas of research that may change the face of clinical drug development in the near future :
  • Regulatory statistics and beyond
  • Statistical inference in biostatistics of the XXIth century
  • Successful marriage between bioinformatics and biostatistics
  • Recurrent event analyses
» Download the flyer in pdf format following this link. or the program in pdf following this link.

Contributed papers will be welcome for an oral presentation if they are relevant to any of these four areas, or as a poster presentation if they describe unrelated but innovative research on clinical drug development.

All invited and selected papers may be submitted for publication in a special issue of Statistics in Medicine.


DAY 1 : Thursday 14 September, 2017 DAY 2 : Friday 15 September, 2017
Regulatory statistics and beyond Successful marriage between
bioinformatics and biostatistics
Invited speakers :

Bruno FALISSARD, Université Paris Sud
Post-approval appraisal: What are the main
methodological issues?

Stephen J. RUBERG, Eli Lilly
Disruptive approaches for clinical trials
pre- and post-approval

Biological treatments with clear-cut mechanism of action, small targeted populations challenge the way regulatory authorities evaluate drugs. Post approval, including market access and pricing implies studies, data and analyses that differs substantially from the routine of large phase 3 randomized controlled trials.
Invited speakers :

Jean-Philippe VERT,
Institut Curie & Mines ParisTech & ENS Paris
Identifying predictive biomarkers in
high-dimensional genomic data from randomized clinical trials

(Leiden University Medical Center)
New directions in multiple testing of biomarkers: Flexible approaches
with rigorous control

Biostatistics was not traditionally involved in data sets counting more than millions of variables, so that omics data opened the door to "newcomers" among which bioinformatics professionals. There is a need to think a global framework in which a marriage between bioinformatics and biostatistics can be considered. Practical examples will surely help to think such framework.
Statistical inference in
biostatistics of the XXIth century
Recurrent event analyses
Invited speakers :

(Leiden University Medical Center)
The future of biostatistics: Robust prediction!

Antoine CHAMBAZ, Université de Paris Ouest
The future of biostatistics: Targeted
learning in action

Statistical inference is the corner stone of biostatistics. The quiet situation that characterized the end of the XXIst century, with the prominence of the very orthodox Neyman-Pearson background, is now over. Even if this important change has been due, in part, to the rise of omics data and of the Bayesian perspective, new research put some interesting light on this crucial question.
Invited speakrs :

Richard COOK, University of Waterloo
Yujie ZHONG, Cambridge University
Marginal and partially conditional analysis of
recurrent events in clinical trials

Mouna AKACHA, Novartis
Are we making good use of our data: Moving
beyond time-to-event data

Cancer, HIV, cardiac or psychiatric diseases are now most often chronic situations. Outcomes collected in trials have thus changed and, most often, they can no more be considered as simply as "success or failure". This raise the question of "recurrent event analysis", a technical but well formulated problem for which many solutions do exist now.