Kert Viele describes how simulation can help you overcome the challenges of designing enrichment studies in personalized medicine

Oxford, UK | 17th September 2012. Tessella, the international provider of science powered technology and consulting services, is hosting a free online webinar, first of an Autumn series, for all life sciences professionals interested in deepening their understanding of Adaptive Clinical Trials.

Join Kert Viele of Berry Consultants to learn how simulation can be used to design enrichment studies in personalized medicine on Thursday 20th of September at 3:00pm GMT.

Personalized medicine presents a clear opportunity for effective treatments better targeted to an individual and their disease. Unfortunately, this opportunity comes with a daunting challenge for clinical trial design. The more we personalize, the more we divide a formerly large disease into a large set of orphan indications, and we can find ourselves caught between two difficult alternatives. If we conduct general trials and pool results, we lose the benefits inherent to personalized medicine. If we conduct multiple separate trials, we must either underpower the separate trials or be faced with vast resource requirements. From a regulatory standpoint, the simple acknowledgement that a disease is heterogeneous raises new hurdles for approval. Pooling results across multiple subsets has problems of bias, and running separate trials produces challenges of multiplicities.

Thus the goal is to recognize the heterogeneity of a disease while allowing appropriate borrowing of information. We present a trial design, called ‘the indication finder’, which uses a Bayesian Hierarchical Model to borrow information across subsets of a disease. The fully Bayesian implementation does this dynamically, meaning that the amount of borrowing is estimated from the data, tending to pooling when subsets appear similar and tending to separate trials when the data show differences between the subsets. Thus the benefits of combining information are utilized only when the data indicate it is appropriate to do so.

We will present the design with examples from real trials, complete with adaptive features concerning subset enrollment (similar to enrichment designs). We will focus on their borrowing behavior, error rates, and the advantages and disadvantages of the design and discuss issues related to potential type I error inflation and possible solutions.

Date: Thursday 20th September

Time: 3:00pm GMT (10:00am EST, 4:00pm CET) for 1 hour plus open time for questions.

Register to attend the webinar http://www.tessella.com/contact-us/other/register-for-the-webinar/

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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 organisations 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. We are proud that our work makes the world a better place to live in: developing smarter drug trials; preserving the digital heritage of nations across the globe; minimising risk in oil and gas exploration; controlling the orbit and attitude of satellites; researching fusion energy.

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

About Berry Consultants

Don Berry is a key opinion leader in Bayesian biostatistics, cancer research and policy, and adaptive trial design. Professor Berry has long championed adaptive trials in clinical research. His vision became reality and adaptive designs have gained favor with pharmaceutical and device companies as well as regulatory agencies. To meet this demand, he started Berry Consultants with Scott Berry in 2000. Since then Berry Consultants has designed well over 100 unique adaptive trials for medical device, biotech, and pharmaceutical companies. Berry Consultants includes 9 full-time statistical scientists and a variety of other collaborators to precisely tailor adaptive designs for each unique company, breakthrough technology, and regulatory situation.

Further information is available at www.berryconsultants.com

Media Contact

Tessella
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Phone: +44 (0) 1235 555511 | Mobile: + 44 (0) 779 9346453 | christina.tealdi@tessella.com

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