The PSDM group of the Biometrics Section (BMS) of the Netherlands Society for Statistics and Operations Research (VVS/OR) organised the event

Adaptive Designs in Drug Development Workshop

Thursday November 8th, 2012
hosted by MSD, Oss



Download presentation (pdf of slides)

Highlights of the event (p and summary):

Adaptive Designs in Drug Development – A workshop by Prof Andy Grieve.

On 8 November 2012 a workshop titled ‘Adaptive Designs in Drug Development’ was held by Professor Andy Grieve. With 61 participants this was a very well-attended workshop.
     Professor Grieve started his lecture by giving an introduction and historic overview of adaptive designs and -thinking. It was explained that the earliest avant la lettre adaptive thinking (Mechanical Randomisation and Simulations) was introduced as early as 1933 by William Thompson in Biometrika. His approach at that time without the current computing resources, turned out to be too cumbersome to generate a lot of followers.

 After 1990, with the advent of sufficient computing power and faced with ever increasing cost of drug development; adaptive designs generated a considerable interest as an alternative to standard designs.

Professor Grieve made a clear cut distinction between relatively easy and well received techniques like sample size re-estimation, and more complex ones like he termed ‘being adaptive by design’, referring to modifying one or more aspects of study designs (even up to study endpoints). These latter adaptations proved to be much more complex, and need a lot of simulation guidance. He provided a comprehensive classification overview of the different AD types versus the compound progression stage.

Another important distinction, especially concerning registration acceptability, is the phase of development of the study. Regulatory authorities are more willing to accept these techniques in the learning phase (up to phase IIB). The role of these techniques in the confirmatory phase (Phase III) has not crystallized fully as yet.

Prof Grieve provided an elegant impression of the state of the art on this statistical frontier. Clearly, more developmental work is needed, which is currently ongoing as several problems surfaced during use of the simulation experiments. Also the regulatory agencies’ acceptance might not yet be at the optimal level for full usage of all the statistical possibilities.
At four o’clock the workshop, which started at 9 am, was ended, albeit that not all topics were fully discussed. Nonetheless, it was a very informative and successful workshop, which was enjoyed by all participants.
The complete slide deck can be found on our website.

08:30 Registration, coffee & tea
09:00 Adaptive Designs course
Professor Andrew P Grieve,Aptiv Solutions, Cologne, Germany
12:15 Lunch break
13:00 Adaptive Designs course
Professor Andrew P Grieve,Aptiv Solutions, Cologne, Germany
16.15 Annual PSDM Meeting
Egbert Biesheuvel, PSDM Chair
PSDM board members
Agenda and Annual Report
17:00 Closure & Drinks

Hosted by MSD, Molenstraat 110, Oss, the Netherlands. Tel. 0412 66 12 22.
Price: €150
Students and Academics will receive a €50 discount