Wyeth to open clinical trial ‘Super Centres’
pharmafile | February 23, 2006 | News story | Research and Development |
Wyeth has unveiled plans to streamline its drug development operations by opening a network of clinical trial 'Super Centres' around the world to manage the crucial stage of drug development.
Most pharmaceutical companies currently manage phase II and phase III clinical trials across hundreds of different sites around the world, but Wyeth now plans to consolidate most of its phase II trials in to just a handful of the so-called Super Centres.
The company hopes the move will bring a number of benefits, including reducing costs, accelerating patient recruitment, reducing the administrative burden and even producing a better clinical profile of the drug.
Officially named Early Clinical Development Centres (ECDCs), the first five will be in the US, Brazil, Eastern Europe, India and China/Hong Kong sites chosen for their ready access to large patient populations.
Robert Ruffolo, the company's head of R&D shared his views on the future of pharmaceutical research at the recent Economist conference in London, and revealed that five of the Super Centres will be ready to begin work in the spring, with a further five ready by the end of 2006.
He said the plans made sense in terms of increasing efficiency and quality control in drug development, and had been modelled on a principle already applied to phase I units.
"We might sometimes have to set up between 100 and 250 sites [in phase II], but I would much rather monitor 5-10 sites when you're working on this scale."
Ruffolo expects 80% of the company's phase II trials to be handled by the centres, which will be under Wyeth's direct guidance but staffed by clinical trials professionals from the local area.
"The cost savings are significant and the quality of data will be high. There are some downsides – we will perhaps have to sacrifice some patient heterogeneity."
Ruffolo also revealed that the company had already made 'staggering' cost savings by working with Accenture to outsource its clinical data management, with one site in the US and the other based in India.
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