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Dr Phil Birch shares his expert insights into the benefits of Adaptive Clinical Trials
August 21, 2013
Dr Phil Birch at Aptiv Solutions shares his expert insights into the benefits of Adaptive Clinical Trials. Dr Birch is leading a one-day program dedicated to Adaptive Designs on September 18th in Boston.
Adaptive clinical trials can dramatically improve clinical trial efficiency and productivity and are rapidly gaining traction in the pharma, biotech and medical device industry. They save significant amounts of money, improve critical decision-making and can reduce late phase attrition. Adaptive clinical trials also have strong ethical backing as they allow patients to either move to more effective treatments earlier or to be removed from ineffective trials.
Simple adaptive designs have been widely adopted in late phase trials where they act as an insurance policy to either stop early for futility or re-assess the sample size to save the trial. Evidence shows that futility stopping saves upwards of $100M per annum if applied at the portfolio level.
In late phase trials futility stopping, however, indicates product failure of which one of the root causes is poor dose selection at Phase II. Industry focus on adaptive design has now turned to exploratory development to enable more effective decision-making before commitment to resource-intensive pivotal trials. One example is the increased interest in Phase II adaptive dose-finding trials where the effective dose of a new drug can be defined more accurately than in conventional fixed design trials. This will lead directly to increased probability of success in Phase III pivotal studies. Both FDA and EMA are urging Pharma to invest more in exploratory phase adaptive design because of the benefits this can bring to sponsor companies, healthcare providers and patients.
The Adaptive Trial Design summit on September 18th in Boston will provide a clear and concise overview of the benefits of adopting an adaptive design strategy and provide attendees with the required knowledge to drive implementation within their own organizations.