Malaria kills one million people a year, most of them children in Africa’s so-called Malaria Belt (the sub-Saharan region). In partnership with the Gates Foundation, pharmaceuticals giant GlaxoSmithKline is preparing an ambitious clinical trial there, which promises to vaccinate 16,000 African children in seven countries with an experimental treatment. The challenge: How do you build a clinical infrastructure that can transmit x-rays and data into GSK’s network in places that have no electricity and no phones?
Ironically, poor connectivity is exactly what could make the trial effective. “The trials have to be in out in the sticks,” where people are actually suffering infection, says Neil Darwent, GSK Biological’s director of IT for R&D, both because of their size and being removed from population centers.
The solution to GSK’s connectivity problem: satellites. Each clinic site has a small satellite mounted on a concrete pad. Otherwise, the sites are relatively simple: a few outbuildings and gasoline generators for electricity. There are a handful of computers, one to run an x-ray machine, and another two or three serve as data collection points, where workers can also access e-mail and the Internet.
The satellite connects back to GSK’s central data collection system, where outside assessors can access x-rays and communicate with staff in the field. (X-rays are required to make sure that malarial symptoms aren’t caused by coincidental problems in the chest cavity.) Information is entered by investigators and uploaded in batches at the end of each day, using GE’s Satlynx service, which has proven itself in Africa before by providing connectivity for oil companies and other exploration firms.
GSK has been working on a vaccine for the African malaria parasite for 20 years, and these large-scale trials represent the third phase of the research. (Phases I and II are conducted in labs, and on smaller populations in the field.) If the vaccine succeeds, it will be the first vaccine in human history to conquer a parasite.
The African trial, which is double-blind, should last four to five years and will take place in 11 sites in Gabon, Burkina-Faso, Ghana, Kenya, Malawi, Mozambique, and Tanzania; when the study goes online in several weeks, one of the Gabon sites will be the first to transmit data. Currently, technicians are testing the connectivity in all 11 sites and getting them ready to go online and begin submitting data on day one.
An 11-site trial isn’t particularly large, says Darwent, but the size of the sample–16,000 children under 17 months old–is one of the biggest that GSK has undertaken. Only vaccines for massive pandemics like influenza are bigger; most trials involve only 500 to 2,000 subjects.
The urgency of the trials justify the expense of having 11 satellite-connected sites. “It’s important we go as fast as we can,” says Daniel Lebeau, GSK Biological’s VP of information and management systems.” That’s the reason we’re using a computerized entry.” Up until a few years ago, all trial data were collected on paper and entered at a central location. “It’s also a race for quality,” Lebeau says. “We avoid misspellings and lost case reports.”