European Statistical Forum
In the past years, companies have increased their focus on the oversight and prevention of potential risks impacting individual clinical studies or the overarching clinical program success by means of subject well-being and protection, data quality and site performance as well as accuracy and correctness of final study results.
This change in perspective has been encouraged by regulatory authorities with both FDA and EMA guidelines released in 2013 for risk-based quality management of clinical investigations and with the release, in 2016, of the integrated addendum to the ICH E6 guideline, specifically addressing the need for a quality management system using a risk-based approach.
Besides continued attention to patient safety and its analysis, two new modalities are emerging in this changing landscape:
The shift in attention from traditional de-centralized monitoring to centralized monitoring of clinical development programs facilitated by the advances in use of electronic data capture
The need to use a risk-based approach using probabilistic methods in focusing resources and in detecting signals.
Statisticians have then been called to develop and implement methodologies for the detection of signals not only impacting subject safety but also potential operational flaws in the clinical study conduct, therefore using not only clinical but also operational data.
The challenges offered by these requirements involve solutions ranging from traditional frequentist methods to more sophisticated Bayesian approaches by means of predictive models as well as meta-analytic approaches, leveraging information across studies and company. In parallel, the introduction of Data Science methodologies through Artificial Intelligence and Machine Learning are offering compelling approaches on how to complement biostatistical methods.
The 10th European Statistical Forum is therefore dedicated to statistical methodologies for safety data analysis, risk assessment and signal detection. This will include presentations focusing on:
- New ways to display, summarize and analyze patient safety
- Innovative statistical methods for the identification of potential risks
- Methods to effectively design and conduct a risk management and signal detection program
- Regulatory view on the implementation of above-mentioned approaches
- Data Science solutions to increase the effectiveness of the monitoring of clinical studies
- Case studies and practical approaches
The conference aims at promoting the exchange of expertise, bringing together statisticians, physicians, regulators, academia and other experts interested in the field of safety data analysis, signal detection and risk management.
Jens-Otto Andreas - Head Statistical Sciences & Innovation - Bone & New Diseases at UCB Biosciences GmbH
Lisa Comarella - Director Biostatistics at CROS NT
Giacomo Mordenti - Director, Statistics & Data Management at Livanova
Marc Vandemeulebroecke - Global Group Head for Dermatology at Novartis Biostatistics