How do clinical trials get funded?
Clinical trials are expensive. Even when the primary research on the drug development has been, animal studies have been completed for the possibility of response, human trials need to be conducted for safety and efficacy. This requires millions of dollars to deliver the treatments and to gather the data and analyze it over the length of the trial and beyond.
One pathway is National Institutes of Health (NIH) funded research, where academic clinicians submit their proposals to study the effects of an intervention on a specific disease condition to the NIH. If funded, they recruit patients to the clinical trial of the drug or procedure. After a specified number have been enrolled, the study is closed. Statisticians then analyze the results of the study, to determine if the intervention has had the desired effect (positive outcome) or not (negative outcome). This process can take several years, at the end of which, there should be an answer, whether the drug or procedure has been beneficial or not. There are different national organizations, e.g. NSABP (National Surgical Adjuvant Breast and Bowel Program) which are dedicated to the study of different diseases. Their panel of doctors and scientists determine which question needs to be answered next to move the knowledge forward, and submit grant applications to have it funded. There are disease specific advocacy groups, which fund specific research, e.g. the Susan G Komen Breast Cancer Foundation, or the Leukemia and Lymphoma Society.
Another pathway is pharmaceutical industry funded research, where companies sponsor clinical research involving the drugs that they produce. They seek out clinicians, who then recruit patients for these studies. With the decline in NIH supported funding, this avenue of funding is providing a growing percentage of clinical trial funding. Unfortunately, whether such research can be free of commercial pressure, overt or not, can be open to question. The funding pharmaceutical company obviously has a vested interest in supporting their drugs.
If specific interventions do not have a parent organization or group involved in furthering that research, they fall by the wayside. Such has been the fate of many promising treatments, which do have a direct financial benefit, or do not have a champion for their use. Such drugs or treatments have come to be known as “orphan treatments”. It will need creative solutions to bring these treatments to the next steps of phase 3 trials.
There is small nonprofit organization called GlobalCures, being developed by dedicated volunteers, that is trying to craft such a solution. They started by searching the literature for small, but powerful studies, which showed substantial benefit by making small changes in surgical, medical and dietary practices, which affect the immunology of cancer. They tried to get these studies started through normal channels, but ran into the wall of funding for these “orphan treatments”. They then took a page from pharmaceutical companies, which advertise “direct to consumer”. GlobalCures is in the process of creating a platform called "Ishare" where people can register, create a profile, share what cancer treatments they are undergoing, and what alternative or complementary therapy they are using. GlobalCures will collate these data anonymously, and hope to track the effect of such treatments. Depending on the disease profile, GlobalCures will make treatment or nutritional suggestions. This will try to give “orphaned treatments” another life. GlobalCures is pursuing therapeutic approaches, which will help the body’s own immune system fight cancer, with drugs and interventions that are already FDA approved, and neutraceuticals that are already being used in common practice. Stay tuned! I am very impressed by their efforts, and am volunteering with them to move the effort forward.