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Nov 10 2014 9:00AM - Nov 11 2014 4:00PM | Tryp Barcelona Apolo
Avinguda del Parallel, 57-59
The last three annual conferences have been co-sponsored by the EMA, MHRA and BfArM. This year’s event - statistical methodology in clinical research and development - is a joint workshop with the AEMPS, the Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios).
Professionals with an interest in the application of, and research into, statistics in the drug development process from the pharmaceutical industry, academia, regulatory and governmental agencies, as well as contract research organisations.
Defining the objective of a clinical trial in the presence of non-adherence to the assigned treatment is crucial for the choice of a proper statistical analysis and the interpretation of the results: the meeting will provide an insight on the different views on the choice of an appropriate estimand (i.e. on what is to be estimated) and the design options and analysis methods related to the selected estimand.
The methodological issues related to the assessment of biosimilarity of biological products for regulatory approval have recently received much attention due to the essential differences between biosimilars and small molecule generics. The meeting will focus on the statistical aspects of the different components in the development of a biosimilar that are required for marketing authorization.
The meeting further aims to illustrate how innovative methods can be used to identify subgroups that benefit in particular from a new treatment and how this knowledge can be integrated into clinical development plans through adaptive and enrichment designs to develop personalised / stratified treatment strategies. Discussions will consider not only the methods themselves, but also how to best implement them in a regulatory context.
Beyond this, the meeting will also serve as a forum for sharing an update on the latest EMA guidance documents and activities, including recent positive opinions.
DIA has blocked a limited number of rooms at the following hotel:
TRYP Barcelona Apolo HotelAvinguda del Paral·lel, 57-59,08004, Barcelona, Spain Tel: (34) 93 343 30 00Fax: (34) 93 443 0059E-mail: email@example.com at the rate of:EUR 85.00 single use incl. of breakfast, excl. of VAT and city tax
To make your reservation, please click here: http://meetings.melia.com/en/DIAEUROPE.html
Important: The room rate is available until 04 October 2014 or until the group block is sold-out, whichever comes first.In case of no-shows the hotel is authorised to charge the full amount corresponding to the duration of your stay.
Registration QuestionsPhone.: +41 61 225 51 51 Fax: +41 61 225 51 52 Monday-Friday 8:00-17:00 CETdiaeurope@diaeurope.org
Agenda and Event LogisticsMagdalena Lewandowska, Event ManagerPhone: +41 61 225 51 65Fax: +41 61 225 51 firstname.lastname@example.org
Global Head Full Development Biostatistics OncologyNovartis Pharma AG, Switzerland
Expert StatisticianAlmirall, Spain
Scientific Director, Biostatistics and DataClinic Hospital of Barcelona, Spain
Head of Biostatistics and Special PharmacokineticsFederal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Director of BiostatisticsF. Hoffmann-La Roche Ltd., Switzerland
Chair of Department of Medical StatisticsGeorg-August-University Goettingen, Germany
Executive Director BiostatisticsMSD Europe, Inc., Belgium
Professor of BiostatisticsCatholic University of Leuven, Belgium
In follow-up studies different types of outcomes are typically collected for each subject. These may include several longitudinally measured responses (e.g., biomarkers, blood values), and the time until an event of particular interest occurs (e.g., death, dropout from the study). Often these outcomes are separately analysed, but on many occasions it is of scientific interest to study their association. This type of research question has given rise class of joint models for longitudinal and time-to-event data. These models constitute an attractive paradigm for the analysis of follow-up data that is mainly applicable in two settings: First, when focus is on a survival outcome and we wish to account for the effect of endogenous time-dependents covariates measured with error (e.g., biomarkers), and second, when focus is on the longitudinal outcome and we wish to correct for non-random dropout. This tutorial will provide a short introduction into this modelling framework. In particular, we will explain when these models should be used in practice, which are the key assumptions behind them, and how they can be utilised to extract relevant information from the data. Emphasis will be given on applications and on how to define appropriate joint models to answer their questions of interest.
Recently, an ICH concept paper on choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials was drafted. In settings where pronounced lack of adherence to the study protocol is expected, the difference between the ideal treatment effect, if the medication is taken as directed, and the treatment effect if the medication is taken as observed is crucial in the assessment of the drug’s benefit. The handling of missing data and the use data observed after treatment discontinuation or change is strongly related to the targeted estimand. An estimand is what is being estimated and precisely defines a treatment effect regarding population, outcome measure, and the parameter defined by the underlying probabilistic model either under the assumption of perfect treatment adherence or incorporating the actual adherence. The session will discuss the use and definition of different estimands and the consequences with respect to study design and analysis in the context of the drug approval process.
A Biosimilar medicine is a growing field. The number of regulatory applications has increased in recent years. This session will highlight the features of the study design options for biosimilar efficacy trials. The choice of margins, their reliability and the different statistical and regulatory considerations associated with them will be some of the topics that will be discussed in this session from both a regulatory and industry point of view.
Precision medicine becomes more and more important in drug development. Among the many topics possible we picked out two, biomarker identification and seamless enrichment designs. There will be a short introduction into the topic, an overview and different methods, then two examples from industry and a regulatory evaluation. Finally the two sessions will be rounded up by a panel discussion.
Session 3 continued: HOW PRECISE CAN PRECISION MEDICINE BE?
Session 4: KEY TOPICS IN REGULATORY STATISTICS