Running Adaptive Clinical Trials: Myth and Reality
Clinical trials that employ frequent adaptation offer great opportunity but pose specific challenges. In this free webinar adaptive trial veterans Martin Kimber and Tom Parke of Tessella will share their experience gained on over 20 adaptive trials. Topics to be discussed include:
- 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
- observed benefits both expected and unexpected
An Example Adaptive Phase 2 Clinical Trial Design for HIV using FACTS
By Tom Parke
Head of Clinical Trial Solutions, Tessella plc
Applied systematically better clinical trial design can deliver even greater benefits to a company’s drug development process.
Tessella and Berry Consultants have more than ten-years of experience helping both pharmaceutical and bio-tech organizations achieve a range of goals at enterprise and trial level, across a variety of indications and a range of trial phases.
An adaptive Phase II trial may determine that subject enrolment can stop earlier than a traditional fixed length trial, or a trial with a fixed manually conducted interim. Stopping enrolment early can save considerable trial time and also money in reduced subject enrolment costs.
We have developed a spreadsheet to help you assess the possible impact of the approach on your trial and on your drug development program… Find out more.
Wyeth Pharmaceuticals reports a trial decision being made
5 months early and savings of $14 million in direct cost
(Drug Information Journal | Vol 43, Number 6 | November 2009 | pp 725 )
and a further trial being closed two months early with 180
fewer subjects used, saving $1.5 million
(BioResearch Compliance Report | July 1, 2007 | Pickett, Joseph).
Expert Opinion
Stanford Medicine: On the verge of a revolution
There’s a good article recently published on the Stanford University Medicine website on the revolution going on in the development of cancer cures and the part adaptive trial designs can play in it. Read more
On Demand Webinar – FACTS Dose Finding and the use of Bayesian Augmented Control
Scott Berry demonstrates the use of the Bayesian Augmented Control feature in FACTS via a worked example. Scott is joined by Martin Kimber after the presentation to answer questions on using FACTS and other trial related topics. Click here to register for the on demand webinar.
The ASCO Post: Can Bayesian Design Streamline Our Sluggish Clinical Trial System?
The randomized controlled trial has taken medical research to a high scientific plateau. But it is more than 60 years old and had changed very little over that period. We cannot be satisfied with the status quo. Read more from Don’s interview with the ASCO post at: http://www.ascopost.com
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