In the last two days, my friend Emmanuel has tried phoning me four times. I have been offline and was not able to answer. I met Emmanuel in Malawi a few years ago when we were staying in the same bed and breakfast. He was working for Direct TV and had been sent to Blantyre to try to increase subscriptions. This in a country where 90 percent of the population lives on less than $2 USD per day. He was frustrated with his work assignment and a bit bored. To distract ourselves we had conversations about our personal lives. Emmanuel lives in Nigeria and has a strong, melodic, friendly accent. His speech comes out in machine gun bursts of words. I love decoding it. For the last 2 years we have intermittently spoken by WhatsApp, sometimes about his work and family, sometimes about mine.
This morning I woke up and a few hours earlier he had both texted and phoned, trying to get my attention. I returned his call and he picked up immediately. Since our experience together in Malawi, he has started a new job. He is no longer trying to sell TV subscriptions in one of the poorest countries on Earth. He has moved into research administration. He was trying to contact me because he had a question. An international research group had submitted a budget to his local hospital. He thought the research budget was very high and was calling me to see if I agreed with him. If I also believed it was too high, he would push Reject.
He thought the research budget was very high and was calling me to see if I agreed with him. If I also believed it was too high, he would push Reject.
Medical research is expensive. Until recently, I have only been the Principal Investigator of observational research studies. In an observational study, people are followed through time to try to assess associations between exposures (colloquially called “causes”) and outcomes (usually referred to as “effects”). An easy example is the association between smoking and lung cancer. In the 1960s, a large proportion of the population smoked. There were suspicions that smoking caused lung cancer. Researchers asked thousands of people with and without lung cancer how many cigarettes they smoked on an average day. The researchers compared the number of cigarettes smoked each day in those with and without lung cancer. Smoking is the exposure and lung cancer is the outcome.
Observational studies are comparatively inexpensive to perform. The National Institutes of Health funds many small observational studies for $125,000 USD or slightly more per year.
On the other end of the cost spectrum are clinical trials, my main focus these days. Clinical trials require that people are administered an intervention to try to change the connection between illness and outcomes. The different treatments patients are assigned to are called “arms.” Usually there is both an active arm and a control arm. The control arm may be treatment as usual or a placebo, depending on the clinical trial’s design. Because of past abuses in clinical trials, they have a tremendous amount of ethical oversight. They are also very expensive. The DON clinical trial, of which I am the Principal Investigator, will begin recruiting patients soon. Our budget is slightly under $1 million per year. Though that sounds like a lot of money, it is actually lower than the actual costs to perform the clinical trial. The National Institutes of Health is giving our research group the drug (and spending a lot of money putting it into those tiny vials you see in hospitals) and performing the data management without cost. If my grant had to pay for these additional items, the annual cost would be 50-100% more.
When Emmanuel explained the reason for his call, my first questions were whether the research budget he was reviewing was for an observational study or a clinical trial. I asked how many sites (hospitals, clinics, countries) would be doing the research. The budget he was reviewing was for an observational study in one hospital unit. The cost was $50,000 USD per year. After our conversation, Emmanuel laughed at his previous naivete and pushed Approve.
