Is medical treatment or advice that we are getting based on a “best guess”? Unfortunately, the answer is often “yes”, which may be followed by “Sorry, but we just don’t have very good information to go on.” Health care is a bit like the practice of law in that decisions have to be made with the best information at the time. You can’t wait to see which back surgery method, or even the choice of nothing but bed rest, is the best way to treat a broken vertebrae. Although medical decision making is getting better all the time, it is still woefully lacking in many critical areas that help physicians and patients pick the best way to proceed.
That is why the National Institutes of Health (NIH) initiated the Clinical Translational Science Awards (CTSA’s). They wanted research to focus more on improving patient care and helping to obtain the preventative advice we need, and they wanted good data to show that this was happening. Lots of research is being done, and it is very high quality, but it seems to take much too long to translate those laboratory findings into improved patient care. The CTSA’s are designed to focus on moving that good research into the first human use (“T1” or “bench-to-bedside” translation), and also out into the wider community (“T2” translation). It is amazing how long it takes good medical practice to migrate from where it is first demonstrated to be effective, into use throughout the country. A few years ago a study showed that this T2 process took about 17 years.
At the University of Florida, we are using this recent (July 2009) NIH funding to find and fix the bottlenecks that slow down both T1 and T2 efforts, and there are a lot of them. Increased regulation for one thing, has a good purpose but is generally perceived as being implemented in a fairly inefficient way. Multiple groups request the same data before starting a project, and often it has to be entered by hand. Biomedical Informatics is a large part of the CTSA plan at UF, and we are already using the vast computing and bioinformatics power available to speed and simplify protocol submissions.
There is wonderful preliminary data from the research labs at UF and other universities, showing that we can slow down and reverse many diseases such as Parkinson’s, liver cancer, and stroke, but the methods have not been carefully demonstrated in ”real” populations. Such testing has to be done very carefully in well planned clinical studies. Phase I studies check the safety first by a closely monitored dose escalation in a few healthy people and then proof of concept in the disease under study. A Phase II study then checks to see if the dose works (efficacy), which is followed by a Phase III study which monitors more patients for subtle and less frequent side effects along with proving the efficacy of the compound. Such studies are often expensive, and that is why many are only done when the cost can be recovered by a commercial product. At a university setting, we have the option of also doing studies on things that might be less useful for generating a profit, such as monitoring the results of a vitamin or a diet change on a disease. The close proximity of the hospital to the academic community ( Veterinary Medicine College, dental school, nursing, physical therapy, and many, many other units) at one site makes UF unique in being able to carry out such work in a cost and time efficient way. Faculty members and researchers from diverse backgrounds can easily meet, have lunch together, and discuss thoughts and plans.
So, why help this effort? Simply put, there are many early research findings and new treatment strategies waiting to be tested in patients who can benefit . The CTSA is the ideal engine that can provide for pilot funding to help get the best projects started and have spent a total of $560,474.00 on 25 such initial studies already, and gotten some excellent results. (Would insert a few lines summarizing best studies). Much more could be done, and it would benefit us all. We hope that you will explore our web page (CTSI.ufl.edu) and help us understand the best way to improve health care and help us to carry out that mission. Suggestions and comments are most welcome!
To financially support the CTSI in its efforts, click here.