As with most healthcare research, funding remains a challenge, with constant friction between the desires for novel therapy versus the need to build on an existing programme to bring therapy to completion. This is particularly apparent when those therapies are not being developed by commercial corporations. Clinical trials are expensive and many agencies do not have the money available to fund them. “In the US, the largest supporter of biomedical research is the National Institutes of Health (NIH),” reveals Koski. “When I applied for my first major NIH grant in 2002, the proportion of grant applications that received funding was close to 20 per cent; that has now dropped to between 5 and 8 per cent.”
It is partly a problem of plurality; there are now so many different cancer-related organisations, all of which are looking to raise money, that it has become something of a competition of who can raise the most. “People have forgotten that we are all in this for the same reason – we should be working together for the same cause,” Czerniecki admits. “Everyone is fighting the bad guy, trying to be the hero that defeats him, but if we stopped competing with one another and formulated a plan together we could defeat cancer.”
With public funding spread ever-more thinly, the importance of alternative funding through private donors and research foundations has significantly increased, and Czerniecki and Koski believe private funding now represents the best chance of achieving their goals, enabling researchers and clinicians to conduct cutting-edge clinical research with near-term impact. In Koski’s view, the reason for this change is the cap placed on traditional NIH awards of US $2.5 million over the course of five years. “This is enough money to perform relatively small phase I or phase II clinical trials to establish the safety of new treatments and hint at possible effectiveness,” says Koski. “However, in order for a new treatment to gain Food and Drug Administration (FDA) approval, it must undergo phase III trials.”
These trials involve a larger number of subjects (100+) whom are randomly assigned either the experimental treatment or the current standard, such as chemo- or radiotherapy. The study is also performed at multiple centers to ensure reproducibility. This makes them too expensive to complete on the existing funding allowance, making it essential researchers explore other sources of capital. The team is also attempting to forge global relationships in an effort to coordinate an international response to this worldwide problem and it is hoped the vaccine may have significant benefits in terms of cancer prevention in poorer countries where screening is not routine.