Adaptive Clinical Trials in the Real World: Lessons from the past 10 years -- Registration Closed

The panel will be held at the MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA. Get Directions.

Schedule

8:00-8:20 Networking and Breakfast

8:20-9:30 Presentation and Q&A

9:30-10:00 Networking

Although Adaptive Clinical Trials have become a hot topic in the last few years, implementations have been going on since at least 1998. Tom Parke, who has led numerous bayesian based adaptive design implementations for 6 major pharmaceutical companies, will be speaking about the experience of making these studies successful.

Successful adaptive trials have occurred when the stakeholders involved in planning and running clinical trials have been able to answer some fundamental questions:

When is it most appropriate to run an Adaptive Clinical Trial?

When in a drug's development is the most appropriate time to conduct an adaptive clinical trial? What indications particularly lend themselves to the use of adaptive clinical trials?

What is the value proposition in the use of Adaptive Clinical Trials?

What's driving the increasing use of adaptive clinical trials? What are the key benefits of adaptive clinical trials? How do adaptive clinical trials impact the whole development program?

What are the difficulties and costs of implementing adaptive clinical trials?

Can we capture the response data quickly and reliably? Can we calculate and agree the adaptation quickly? How do we implement the adaptation? How does one effectively manage the clinical drug supply chain in an adaptive trial? How do we get all the stakeholders aligned so the trial is a success? From a clinical operations perspective, what are the challenges in managing a complex trial that could have from 300 to 800 subjects at multiple sites in different global locations?

How do we go about deploying adaptive clinical trials?

How do you make it mainstream and industrialize the process?

In his presentation Mr Parke will give answers to the above questions based on 10 years of experience handling the diverse array of "cross silo" challenges that are thrown up by going adaptive.

SPEAKER

Tom Parke, Head of Clinical Trials at the Tessella Group

Tom Parke has been working on Adaptive Clinical Trial projects for 10 years and his work with Dr Mike Krams (first at Pfizer and now at Wyeth) and Don and Scott Berry of Berry Consultants has garnered considerable attention. Tom has helped implement 5 adaptive phase 2 dose finding trials that are now complete, for a number of pharmaceutical companies across a range of indications. For these trials, he managed the development of simulation tools, systems to support the running of the trials and the integration of adaptive algorithms with existing IVRS and EDC systems. He is currently working on his next five adaptive dose finding trials, and consulting with a number of companies to help them define the software systems they require to move adaptive clinical trials into their mainstream activities. Before working at Tessella, Tom was with Praxis (part of Deloitte & Touche) where his work included software for imaging systems for GE Medical Systems and Varian Oncology.