March 19-20, 2012
I like to compare improving efficiency in clinical trials to eating an elephant; where do you start? With an industry that spans hundreds of companies, thousands of people all over the world, and a process that must be rigorously controlled, at some point you need to make a decision to start somewhere and build from there. This is the thought behind the FDA/PhUSE Annual Computational Science Symposium (CSS). FDA and PhUSE have worked together to define the first pieces of the elephant by defining six working groups. The topics of these working groups include: data validation, reducing risk with site selection, integrating data, converting data (CDISC SDTM), implementation of CDISC models, developing standard analyses, and non-clinical data standards implementation (CDISC SEND). Over time these working groups will evolve and the topics and issues of greatest interest will rise to the top. http://www.phuse.eu/Working-Groups.aspx
But let’s not get ahead of ourselves; these core topics are already challenging by themselves. How are we, as an industry, going to make significant advancements on this idea? Powerpoint, while good at presenting an idea, is not ideal for collaboration. The model of presenting and listening needs to evolve; we need to sit down, roll up our sleeves, dive into the details and begin putting a plan in place on how to move forward. It is understood that solutions are not going to be miraculously discovered in a two-day meeting. Working groups initialized at the CSS 2012 will continue throughout the year documenting progress on the PhUSE Wiki. CSS 2013 will start with a presentation of the work that had been completed and a kick off of next year’s goals.
The major focus of the meeting is the working groups and the majority of the time will be allocated to them. To kick off the meeting, and to keep us all grounded on the overarching state of data standards and FDA initiatives, the CSS 2012 will start with an update from the FDA and CDISC. The FDA will discuss updates from the Computational Science Center, update on PDUFA V, and CBER’s progress and next steps. CDISC leadership will present an overview of current and near future CDISC initiatives. The draft agenda may be found here, http://www.phuse.eu/CSS-2012-Agenda.aspx.
While there are no presentation spots available, there is a call for posters. Presenting a poster is a great way to both present an accomplishment and solicit feedback from industry’s best and brightest. As a way of making poster presentations more interactive, software demonstrations can complement the poster showing a live demonstration of what the poster illustrates. The best poster will be recognized and will be offered the opportunity to present their poster at the closing session.
Register through the following link: https://www.phuse.eu/PhUSE-Conference-2012-Registration.aspx
Daniel Boisvert (Daniel.Boisvert@phuse.eu)
Chris Decker (Chris.Decker@phuse.eu)