GSK: Clinical Trials, African Style
In a bid to bring a malaria vaccine to market, GSK Biologicals has established clinical trials across 11 sites in seven countries within the African 'malaria belt.' However, the lack of a communications and technology infrastructure, not to mention electricity, in these areas, meant the trials were set to progress at a much slower pace if 'traditional' methods were used to collect the data; particularly when approximately 16,000 baby and young infant patients are expected to participate in the trials.
With funding from the Bill and Melinda Gates Foundation, GSK Biologicals developed a ruggedised technology infrastructure capable of transmitting x-rays and data directly from the African locations, via a NSS-7 satellite, to a ground station in Europe. The medical data is then reviewed by a panel of independent radiologists and the results transmitted back within a 12-hour period.
GSK's Neil Darwent, Director of Information Technology, and Roger Cooper, Project Manager, Global Clinical R&D and Vaccine Development, talk to Pharm Exec Europe about some of the challenges and hopes surrounding this innovative project.
PEE: How did the decision to use satellite technology come about and what were the cost implications?
Neil Darwent: The study is set to last 4-5 years, and if there is a local cable infrastructure in place within that time, we could switch to it quite easily. But in terms of response time and the time it takes to send the x-ray images, we can get the performance we need from the satellite link. The x-ray images are 10-20 megabytes in size, so we never had an expectation that they would be transferred in a matter seconds or even a few minutes. We've done many tests and it takes about 30 minutes to send an x-ray; individual sites will be sending between one and three x-rays per night.
As far as cost in concerned, the value of the trial is enormous, but the cost of the technology is falling. And a crucial factor is the number of sites. If this project had only involved one or two sites, it probably wouldn't have been viable, because approximately 80% of the cost has been invested in the overall infrastructure, with 20% on a site-by-site basis. With 11 sites, it becomes possible to spread that cost, and when we add a twelth site, which we are doing for a different trial, the incremental cost is just a few thousand Euros.
What challenges have you faced in setting up the satellite system?
Another issue we faced was dealing with the authorities; getting telecommunications licences could be a long and somewhat tortuous process. In Malawi, where we're just finishing up the installation, we had a four-month delay in getting the licence, and the importation of the equipment could only happen after that.
The Bill and Melinda Gates Foundation is waging a very high profile fight against malaria. What kind of pressures has this brought?
ND: The funding from Bill and Melinda Gates is exactly that funding. However, Bill Gates was with us in Belgium a few weeks ago and he was personally putting enormous pressure on the project, asking when can you start, can you do this four-year study in three years, that kind of thing; he's very committed to getting this vaccine to market as soon as possible.
There was a time last year when we were on the critical path in terms of getting the infrastructure in place, but that's just like a normal IT project. There's no denying, however, this is a high visibility project.
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