Design and Analysis of Clinical Trials

Target group

We target both PhD-students and (young) researchers from the Faculty of Medicine and Health Sciences and PhD-students and researchers from the Faculty of Science with limited experience in clinical trials (especially PhD students in science) and non- statisticians (PhD students in medicine and health sciences or veterinary medicine, medical doctors, data mangers, etc.) who are involved in clinical trials or who are interested to work in the field of clinical trials and who have had an introductory course in statistics.

Organizing Committee

  • Prof. Dr. Els Goetghebeur (Faculty of Science, Department of Applied Mathematics, Computer Science and Statistics, )
  • Prof. Dr. Tine Willems (Faculty of Medicine and Health Sciences, Department of Rehabilitation Sciences, )

Topic and theme

Design and analysis of clinical trials is a rapidly growing field with many new approaches. This summer school brings together experts in the subject since top researchers will give a number of advanced lectures. Attendees will be introduced to current methods to feed the needs of statisticians and clinicians who are currently performing or want to perform a clinical trial in the future. By helping PhD students improve their skills in clinical research and statistics in a highly interactive environment based on hands-on workshops and tutorials, this course will promote personal and professional growth and help participants become more efficient in their work.

A close collaboration between the 2 domains is highly desirable. Researchers from the Faculty of Medicine and Health Sciences mostly plan and conduct the clinical trials but rely on statistical input to adequately design and analyse the trial. Practical decisions in light of events emerging during the trial also require a good understanding of potential biases and risks involved to avoid invalidating the results. Researchers of the Faculty of Science develop statistical designs and good methodology to analyse them but need the clinical interaction to be aware of what is feasible in resource limited practice. To facilitate the interaction, both groups need training on the subject.

Aim

This course aims to bring together PhD students and other participants of various backgrounds and levels of involvement in clinical trials. We aim to bring these partners to the level where they have a clear view of how a clinical trial is set-up and give an introduction to the statistical principles which form the basis for the design and analysis of clinical trials. The course will concentrate on the understanding of statistical principles that are used on a day-to-day basis in conducting clinical trials. Furthermore, throughout the course, concepts will be highlighted that are of concern like feasibility, adherence and compliance.

Format

We will organize both plenary and parallel sessions (scientific and clinical) to allow participants to gain complementary skills needed in the design and analysis of clinical trials. Parallel sessions will allow the students to choose the topics they are interested in at their level of knowledge. Two workshops are foreseen: one on design and sample size calculation to allow participants to get involved form their perspective in important aspects of the design including sample size calculations using software and trial simulation, and one on analysis. During lunch, round tables will be organized. PhD students can then choose a topic which will be allocated per table and to whom an expert (lecturer) will be assigned.

Objectives

Young researchers who will present their research will benefit from feedback from the team of expert lecturers. PhD students improve their skills in clinical research and statistics in a highly interactive environment based on hands-on workshops and tutorials, this course will promote personal and professional growth and help participants become more efficient in their work.

Lecturers

  • Prof. dr. James Carpenter is Professor of Medical Statistics at the London School of Hygiene & Tropical Medicine and Programme Leader in Methodology at the Medical Research Council (MRC) Clinical Trials Unit based at University College London.
  • Dr. Nicolas Delvaux works at the Academic Center for General Practice at the KULeuven and is a family physician. He coordinates the ELMO clinical trial in Belgium
  • Dr. Ellen Deschepper is biostatistician at the biostatistics unit of the faculty of Medicine and Health Sciences.
  • Prof. dr. Luc Duchateau works at the Department of Nutrition, Genetics and Ethology Biostatistics, at the Faculty of Veterinary Medicine of the Ghent University and a visiting professor at Hasselt University.
  • Prof dr. Els Goetghebeur is professor of statistics at Ghent University, expert in causal inference and survival analysis.
  • Prof. dr. Kim KyungMann is Professor of Biostatistics at the Department of Biostatistics and medical information of the University of Wisconsin-Madison School of Medicine and Public Health.
  • Dries Reynders obtained a master in Physics and a master in Statistical Data Analysis at Ghent University.
  • Prof. dr. Wim Van Biesen is head of the Department of renal diseases at the Ghent University Hospital and Professor at the Department of Internal Medicine and Pediatrics at the Ghent university. He is member of the Ethic Committee of the Ghent University Hospital.
  • Prof. dr. An Vandebosch is Scientific Director Statistical Modelling & Methodology at Janssen and professor at the Ghent University, department of applied mathematics, computer science and statistics.
  • Prof. dr. Catherine Vanderstraeten is head of HIRUZ, the Institute for Health, Innovation and Research Institute of the Ghent University Hospital.
  • Prof. dr. Geert Verbeke is Professor in Biostatistics at the University of Leuven and University of Hasselt and is expert in longitudinal data analysis.
  • Prof. dr. Tine Willems is guest professor at the department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences and works as a consultant at the Center for Statistics of the Faculty of Sciences at the Ghent University.
  • Professor Jonathan Sterne is Professor of Medical Statistics and Epidemiology at the Bristol Medical School of the University of Bristol.  He has a longstanding interest in methodology for systematic reviews and meta-analyses, the clinical epidemiology of HIV and AIDS in the era of antiretroviral therapy, causal inference, methodology for epidemiology and health services research. He is co-author of “Essential Medical Statistics” and published in 2019 in The British Medical Journal the RoB 2 tool, an updated version of the most widely used tool for assessing risk of bias in randomized trials included in systematic reviews.

Dates & Programme

The course has been cancelled by the organisers and will be re-organised in 2021, dates to be confirmed.

Registration

Please follow this link: https://eventmanager.ugent.be/clinicaltrials

Evaluation criteria (doctoral training programme)

Full attendance (at least 80%) of the first 4 days and active participation are the main criteria for recognition of the seasonal school by the doctoral schools.

Number of participants

40 PhD students