Advanced Methodologies for Clinical Trial


Course description:

In evidence based medicine, randomized clinical trials (RCT) is considered as the most scientifically rigorous method of hypothesis testing. RCT is the gold standard trial for evaluating the effectiveness of interventions. However, there is no “one-size-fits-all” when designing an RCT.

The aim of this workshop is to provide a comprehensive review of various designs of RCT ranging from traditional designs to the state-of-the-art adaptive designs (ADs), including both frequentist and Bayesian approaches.

Key points will be illustrated through several case studies from presenters experience across the whole development space from early development through to late phase confirmatory studies. A wide range of therapeutic areas will be covered. Frequent practical sessions will be organized to ensure attendees will be able to apply new concepts for their own studies.

The more advanced part of the course is devoted to adaptive designs, a novel approach to improving the efficiency and flexibility of clinical trials. As well as learning about how to design adaptive trials, practical aspects and interactions with the regulators will also be discussed. Real examples will be used to illustrate how frequentist or Bayesian methods work. A strong emphasis will be placed on learning how to use the R package to implement such methodology in practice.

Day 1: Methodological Introduction

Day 2: Bayesian methods in clinical trials

Day 3: Adaptive designs using R

Day 4: Adaptive designs using R

Day 5: Adaptive designs using R

Tuition fees:

External students: academia 990 CHF, others 1’350 CHF,

UNIGE students: 600 CHF (limited number of places)

Program Director:

Prof. Maria-Pia Victoria-Feser, Geneva School of Economics and Management, University of Geneva


Instructors:


Dr François Curtin, MD, MPhil, MBA

François Curtin graduated in medicine from Geneva University and obtained a Master in Philosophy in Medical Statistics from the London School of Hygiene and Tropical Medicine as well as a MBA from Warwick University. After several years in academia and obtaining his habilitation (Privat Docent) at the University of Geneva, he joined Swissmedic, the Swiss Medicine Agency in Bern, then worked for Merck Serono SA and Geneuro SA, notably in charge of clinical development. François teaches biostatistics, trial methodology and pharmacology at the Geneva School of Economy and Management and at the Faculty of Medicine of the University of Geneva.


Associate Professor Stephane Heritier, MBA, MSc, PhD

Stephane Heritier is Associate Professor of Biostatistics at Monash, a university ranked in the top one per cent of world universities. He has 20+ years of experience in clinical trials gained in various institutions such as Merck Serono (Geneva), the Clinical Trials Centre and the George Institute (Sydney, Australia) and now Monash (Mebourne, Australia),. He has been involved in the design and analysis of about 90 clinical trials including a phase 2-3 seamless adaptive design Hemangiol accepted by the American and European regulators and more recently, REMAP-CAP, a large platform trial in community-acquired pneumonia. Stephane is an expert in adaptive designs and is pursuing his own research program in clinical trials methodology. He has co-authored about 120 papers and been the recipient of various clinical trials grants.


Dr Serigne Lo, DEA, Astat, PhD

Serigne Lo is the Head of the Research & Biostatistics Group at the Melanoma Institute Australia a world leading clinical research in melanoma and Senior Lecturer at the University of Sydney. Overall, Dr Lo has +15 years of experience, including over 12 years postdoctoral experience in medical research. Prior to joining the Melanoma Institute Australia in 2015, Serigne has worked at the George Institute for Global health for over 8 years.Over his career, he has provided statistical consultation on countless clinical trials, providing expert advice on the appropriate use of statistical techniques for the design and assessment of clinical studies. Over the past 5 years, Serigne has designed more than 50 clinical phase II and III investigators-led trials in skin cancer and has led the analysis of three clinical trial studies, one published in New England Journal of Medicine and two in Lancet Oncology. Serigne was the trial statistician of one of HEMANGIOL study on the the first adaptive design trials that obtained marketing authorisation for the paediatric drug Hemangeol from FDA and EMA in 2014.


Dr David W. Warne, BSc, MSc, PhD, CStat

David Warne graduated in Mathematics and Statistics from Warwick University and obtained an MSc in Applied Statistics and PhD in Medical Statistics from Reading University. He has worked for over 25 years in pharmaceutical development, 3 years at Ciba-Geigy in Basel, 12 years at Serono and 6 years at Merck Serono, and 6 years as a Consultant in Geneva. He teaches biostatistics and trial methodology at the Geneva School of Economy and Management and at the Faculty of Medicine of the University of Geneva.