In this free webinar Tom Parke discusses key questions about the use of quantitative decision making in drug development through simulation. Model based drug development produces estimates of the likely response to a drug, how should this be used to design a trial? The environment for drug development is becoming more complex, with issues such as sub-population analysis, safety, comparative effectiveness and using drugs in combination is more and more commonplace. How can development teams decide what to explore in the next trial and how can they decide whether to continue or abandon development?  Simulating all the remaining phases of development up to registration and comparing the performance of different strategies is one approach. But is it too complex? Is there too much uncertainty? Will it take too long to run? Could the results be trusted?

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Oxford, UK | 15th December 2011. Tessella, the international provider of science powered technology and consulting services, is proud to be hosting a free online webinar for all life sciences professionals interested in deepening their understanding of Adaptive Clinical Trials.

Clinical trials that employ frequent adaptation offer great opportunity but pose specific challenges. In this free webinar adaptive trial veterans; Tom Parke (Head of Clinical Trial Solutions, Tessella ) and Martin Kimber (Project Manager, Adaptive Clinical Trials, Tessella) will share their experience gained on over 30 adaptive trials. The webinar will discuss: what these trials are, why people run them, how they are designed, how the logistics to run them are put together, what it’s like to run one as well as observed benefits both expected and unexpected.

The “Running Adaptive Clinical Trials; Myth and Reality webinar” will take place on Thursday December 15th 2011, 3:00 PM (GMT) Greenwich Mean Time: Dublin, Edinburgh, Lisbon, and London. To register online for the event visit: https://tessella.adobeconnect.com/_a970567468/runningadaptivetrialsevent/event/event_info.html

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Notes to the Editor

About Tessella
Founded in 1980, Tessella is the international provider of science powered technology and consulting services. World leading organizations choose our unique blend of science, engineering and sector expertise to deliver innovative and cost-effective solutions to complex real-world commercial and technical challenges. Our people are high achievers from leading universities and are passionate about delivering value to clients.

For further information visit our dedicated microsite on http://www.smarterclinicaltrials.com

Media Contact

Tessella
Christina Tealdi | Public and Analyst Relations Executive
Phone: +44 (0) 1235 555511 | Mobile: + 44 (0) 779 9346453 | christina.tealdi@tessella.com

Kevin Vogelsang, Clinical Technologies Business Development at Tessella Inc. will be talking about Designing Smarter Trials to Support Personalized Medicine on Wednesday, September 7th 2011 from 11.45am to 12.15pm.

To find out more about this event or to register online, visit http://www.adaptcongress.com/

You would like an prearranged meeting with Tessella, please email info@tessella.com

Meet Tessella’s Martin Kimber, Project Manager, Adaptive Clincial Trials at DIA who will also be demonstrating FACTS at the stand. 

To find out more or to register for this event visit http://www.diahome.org/

Tom Parke, Head of Clinical Technologies, Tessella

I was lucky enough to join a focus group at the recent 8th Annual SAS Health Care & Life Sciences Executive Conference (http://www.sas.com/news/preleases/hlsconf-clinicaltrials.html). The group comprising of selected pharmaceutical industry executives, SAS, Berry Consultants and Tessella discussed clinical research best practices.

So what did the group observe? Two points struck me:

1. The growth of personalised medicines, increased use of biomarkers and intensification of comparative effectiveness studies are making drug development more complex than ever. Smarter clinical trials are seen as a key method to respond to this complexity.
2. Concern that companies will need to break down silos and increase inter-operability between groups and IT systems in order to execute trials in an agile and flexible fashion.

The second point could be seen as pessimistic, yet the recent Perceptive Informatics global survey (http://www.perceptive.com/news/press-releases/2011/perceptive-informatics-global-survey-results-show-growing-indust/) is encouraging. It shows that despite these concerns the industry’s willingness to use innovative approaches in clinical trials, such as adaptive trials, is growing. During a recent webinar presented by Perceptive and Tessella, more than 300 industry professionals answered questions about implementing adaptive trials. The survey showed that 80% of respondents were considering implementing adaptive trials within the next year.

Growing implementation of adaptive clinical trials following the publication of draft guidance on adaptive designs by the US Food and Drug Administration in February 2010 is helping to ease regulatory concerns within industry about the approach, says eClinical solutions specialist Perceptive Informatics…read more

Tom’s topics are:

• Incorporating biomarker data in clinical trials for developing personalised medicine
• Commercial Software Solutions for Exploratory Studies
• Using simulations to communicate the expected consequences of planned statistical analyses

To find out more about Tom’s sessions or about this event and how to register online, visit http://www.diahome.org

To find out more about the webinar and to register online, visit http://www.perceptive.com

Tom Parke be giving a talk on:

• What adaptive clinical trials promise

• What it takes to run an adaptive trial

• What can go wrong and how to prevent it, dodge it or cope with it.

To find out more about this event or to register online, visit www.perceptive.com/news/2010-user-group-meeting/