John Donnelly interviews Dr. Roma Chilengi, head of clinical trials at the KEMRI-Wellcome Trust Research Programme in Kenya.
Dr. Roma Chilengi was the head of clinical trials at the Kenya Medical Research Institute(KEMRI)-Wellcome Trust Research Programme in Kilifi, Kenya, from 2008 until April 2011. While he worked on several vaccine trials, Chilengi specialized in malaria vaccine research and was the coordinator of programs and trials at the African Malaria Network Trust. Part of his work was on RTS,S, the world’s most advanced malaria vaccine candidate. Chilengi has been a lead malaria researcher since 2003 and recently joined the Center for Infectious Disease Research in Lusaka, Zambia, where he will be overseeing the rollout of a rotavirus vaccine in a pilot project.
He spoke with John Donnelly from Kilifi, Kenya. This is the fourth of five pieces on the importance of global health research and development that coincides with the Global Health Technologies Coalition‘s (GHTC) annual report, and GHTC’s May 3 Hill briefing.
Q: How did you get started in malaria research?
A: In 2001-02, I received a fellowship for a training program at GlaxoSmithKline Biologicals (GSK) for post-grad learning in clinical research and vaccine development. The program was modeled around vaccines, and it was working with the RTS,S vaccine in its development pipeline. I was then hired by GSK Trust to set up a clinical trial platform that would look for orphaned malaria vaccines and prepare trial sites across Africa.
Q: What are some of the lessons in setting up a clinical trial?
A: There are many lessons, I think. From a trial sites’ setup perspective, you have to do a clinical trial properly. … Most of the institutions in Africa … are not in a position to invest resources that are necessary. The institutions that have done well with clinical trials are those in which the head of institution recognizes a need to invest in them and give them enough resources. There are only a few of them in Africa.
Q: Is there too much reliance on international organizations?
A: I would call it a proper reliance.
Q: Why? Because of funding?
A: A large part of it is due to funding, but a fair proportion is due to the initiative and the drive by the heads of institutions. A clinical trial initiative has to be a five- to ten-year dedicated investment, not a one- or two-year trial. The organization I work for has been in an ideal situation over the last ten years with dedicated support from the Wellcome Trust, which has put in the structure and investment and created a dedicated leadership team.
Q: Still, running trials often is a very challenging process. What challenges most concern you?
A: Internationally, there’s been an issue with populations that have been over-researched. This is inevitable. When a good trial site is established, they will do more and more research there. In time, you have a population that is participating in several trial and research studies, and that raises two main issues. One is that to conduct clinical trials, we are obligated to produce the best possible care for those enrolled. There are no excuses. When you do that in an environment with poor health care, this disparity brings some tensions at the community level, and there is discussion whether volunteers are doing this under voluntary consent or doing this because of the benefits from the trial.
The other issue comes up when the community begins to perceive the volume of research as too much. Questions come up about where we get our resources to have such vehicles run around the trials. Other times, people said the research is associated with some sort of devil worship and sacrifices. This is heightened because we typically have to take a lot of blood samples. From time to time, we invite members of the community into our lab so they can see what happens to our blood samples.
Q: The RTS,S vaccine is the world’s most advanced malaria vaccine candidate in trials. What’s the future for a highly-effective malaria vaccine?
A: It is obviously a very great achievement to the global malaria community that we now are at this point. A lot of malariologists had problems believing or even thinking about the possibility of a malaria vaccine. What we have done is bring this possibility very, very close.
Q: What motivates you to do this work?
A: Earlier in my career, I worked as a doctor. I was very quickly faced with the fact that health care practice is very hard in resource-constrained environments. You are faced with the same patterns, same constraints, and things aren’t going anywhere. I felt I could be of more value if I moved up to a research career. I felt I could do something with a bit more results and more meaningful in terms of helping more people.
Q: What has been the impact of US Government and philanthropic investment in infectious disease research?
A: I’m broadly aware of the great impact of programs from National Institutes of Health and the President’s Malaria Initiative, and the ability of those funds has enhanced research activity across Africa. … If MVI (the PATH Malaria Vaccine Initiative) had not partnered with GSK on RTS,S, we probably would not be talking about a malaria vaccine right now. The Bill & Melinda Gates Foundation philanthropy has had a huge impact.
Q: Why was MVI critical to this effort?
A: Through the partnership, MVI gave the money to move the program forward. GSK, although it invented the vaccine, was not going to do much about it without outside investment. RTS,S was like many malaria vaccines out there in academic laboratories and institutions without support. What MVI did in the partnership was to give resources to GSK to move the vaccine. To put this in perspective, the European Commission has identified three vaccine candidates and is putting eight million Euros (more than $11 million) toward it. For RTS,S, you are talking about hundreds of millions of dollars of investment. Without money, these things can’t be done.