I have the greatest respect and admiration for the NIH but they are missing something.

In the medical and scientific research fields there is the concept of “Translational Research” where research discoveries and developmental research are passed step by step to make things that are useful. Things like drugs, new devices, cutting edge things that enrich our lives. Hopefully everyone reading this will realize new technologies like magnetic resonance imagers (MRI) and “keyhole” surgery are advances that are examples of Translational Research success. However what is happening is that the federal government is missing some important steps in funding “Translational Research” and the result is: The Valley of Death.

The Valley of Death is a research stage where no one wants to fund the next step. It occurs between the “Translational Research” steps. The NIH and NSF are great at funding new discoveries and certain steps in clinical advances. This is referred to as, “Hypothesis Testing” in most research circles. But the NIH and NSF generally do not take a tested hypothesis and make it ready for developing into something useful. That is often done by companies. But companies frequently consider “Hypothesis Tested” research as too soon to fund for development. The resulting the valley of death means that idea or product will fail because it is too far along for the Feds to fund and too immature for a company to take on for product development.

I however see nothing wrong with the NIH, NSF and even charitable foundations in supporting “Valley of Death” research. Unfortunately even if they did decide to fund such work (and some agencies are taking this on) what happens is that researchers are shying away from that type of research (validation, dose ranging, toxicity etc) because it is not publishable. It does not help a professor’s career to validate someone else’s drug as safe. To use a baseball metaphor, that would be a sacrifice fly. As a player I do not mind a sacrifice fly, but it is not what I am hoping for. Everyone wants to hit the home run and validate that the drug is effective. The other part of the reason that few want to do this research is that it takes too much time and effort to over see such a project because of strict FDA rules with minimal chance of professional advancement via publications etc.

So, do I have a suggestion to fix this? Well, yes, I do. I would suggest that the Federal funding agencies give special consideration to fast track the nitty gritty steps needed for “Translational Research.” Say for example, I will agree to verify the safety of a medical device that “X-rays” a patient with out using harmful radiation as required required by the FDA. If I do this it is likely that a company would be interested in making the device and getting it past the FDA for next steps. Therefore, the NIH could fund my work, but decrease the amount of work needed to write the grant, make the grant review faster, and get the funding sooner so that I have time to still be a successful college professor. That way good ideas and technologies will be developed by scientists and professionals with the skills to do the experiments and patients will eventually benefit sooner rather than later.

For anyone who is wondering how long it takes to write and submit a major government grant the short answer is about 3 months. The longer answer is that the average length of a grant application is about 16000 words and 60 references. The 60 references means reading at least twice that number of journal articles as background. There is also hours of meetings and compliance reviews. Finally there are innumerable levels of review and documentation concerning the finances that go into the grant. The result of the long answer is, about 3 months of work.

It is important to note that nothing unethical or untoward is involved with my fast track suggestion. This is because there are multiple regulatory steps which are necessarily involved before such things are approved for use by the FDA. Therefore all the safety steps regarding oversight and disclosure will still be required. Everyone benefits and my sacrifice fly (metaphor above) can be part of a game winning strategy.