The ongoing development of a revolutionary shift in the structure of clinical trials known as Learn-Confirm, was warmly received by regulators, industrialists and academics gathered in Vienna for the 19th annual Drug Information Association conference this week.
Dr Charles Gombar, Vice President of Project Management for Wyeth described how the Learn-Confirm principle of clinical trial investigation was firmly grounded in science. He explained how this approach to drug development is designed to minimise rejection and attrition of R&D at the later stages. Gombar feels that the conventional phased clinical development programme has become so ingrained that it is treated like a law of nature and that the current shift in thinking is long overdue.
Asking the right questions
“As long as we can show evidence of benefit over risk to the regulators in clinical trials then we should satisfy the need. Pharma needs to start thinking differently about asking the right questions to obtain valuable data. I don’t care which phase it is in,” he explained.
In 2005, Wyeth launched Project Springboard to reconfigure the way the company was preparing for future challenges in all spheres of the business from manufacturing through to commercial operations. The Chief Executive approached Gombar and his colleague Evan Loh to deliver a radical unprecedented new plan for investigating compounds at the clinical level.
Nicknaming themselves the ‘Wacky Thinker Group’, Gombar and his colleague went back to the drawing board and radically rethought how clinical trials could deliver more substantial, reliable evidence which better meet the needs of drug regulators and customers.
Gombar’s plan stems from a concept advanced by the late Dr Lewis Sheiner almost a decade ago. It is based on the principle of Learn-Confirm. Learn refers to investigations that start after the basic science is complete, including pre-clinical and early clinical trials. “Since January 2006, Wyeth has based our research teams around these principles so we have Learn teams and Confirm teams. This allows our researchers to become real disease experts who address fundamental concerns about treating the disease early on, minimising error later,” said Gombar.
A shift in thinking
On the back of this shift in thinking, Wyeth has now opened Early Clinical Development Units in India, China and Eastern Europe where the magnitude of patients is far higher than in the West. “We wanted to address the issue of why R&D is always focused in the US. We identified a subset of clinical activities that can be dealt with around the world on a 24/7 basis. So when we sleep, they work and vice versa.”
Dr Lawrence Lesko, Director of the Office of Clinical Pharmacology, FDA says that it will take a few years for the rest of industry to adopt this new approach and that success will also rely on people with the ability to ask the right questions and supply people’s needs. “The changes in clinical trial outcomes will not become evident for 6-8 years and that also depends on how people value their results. If it means that 25% of patients fail phase III studies rather than 50% then that’s a good thing. If Wyeth receives lots of drug approvals on the back of this then they’ll all want to know about it,” he said. By Becky McCall at the DIA conference in Vienna, Austria