There has been a great deal of news recently about phase III clinical trial research that has failed to meet end point goals.
In some cases the studies have failed to meet the expectations of the researchers and of patients.
In others the benefits have not been as promising as hoped.
I thought it would be worthwhile to dig a little further into this issue and take a look at the innovative pharmaceutical investment model as it relates to success and failure.
Discovering what we don't know
I blogged earlier this summer about the differences between generics and innovative /brand pharmaceutical companies, and noted that novel research is one of the key differences in their research models.
Generics simply copy existing research. They research what we as a society already know.
There is no furthering our collective understanding of a neglected disease to hopefully find a cure, and there is little to no investment risk for generics as a result.
For our part however, innovative clinical research always has some element of scientific and investment risk. Of note, out of 5,000-10,000 compounds in drug discovery - only 1 makes it to patients. And the cost is approx $1.3Billion.
This is why intellectual property protection is so important to our sector. It is a key element to ensuring that innovative research takes place on the scale needed to achieve medical breakthroughs.
What about failure?
Innovation is all about trial and failure. In order to find out what we don't know, we have to take a risk on a scientific premise and see if it works or it doesn't.
Importantly, while drugs may not act the way scientists hope they will whether in phase I, II or III trials, often, it is this process of trial and error that leads to breakthroughs in unexpected and sometimes new ways.
Also, by increasing our collective understanding of how a disease works through this novel research, new pathways of research can be opened up.
William Thies, chief scientific officer of the U.S. Alzheimer's Association made this point by noting "These studies are terribly important for us to learn about Alzheimer's disease, and that part of the process is just starting as the data continues to be crunched in a variety of ways,"
Finally, ongoing research on existing molecules that have been successful continues even after a drug has been approved for use with patients. Improving treatment regimes and efficacy, working to simplify frequency and method of drug administration, all work to further novel research for the benefit of patients.
A win for patients
I really believe that the risk to Canadian society of not looking for treatments in some of the most complex and under-researched areas is too great. With an ageing population, finding treatments to devastating neurological diseases in particular is more important than ever.
Working to achieve the benefits of this innovative research must be encouraged and supported in partnership with governments, researchers, health professionals, patient groups and the private sector.
As the recent ACAHO, CIHR and Rx&D clinical action plan To Your Health & Prosperity...An action plan to help attract more Clinical Trials to Canada notes:
"Clinical trials are needed to bring drugs, devices, and vaccines developed through science, safely to market. They bring innovation from the bench to the bedside. If the trial proves to be successful, it can even give the participants a chance to be relieved of pain, illness, disability or discomfort by accessing innovations, even before they are commercially available."
You don't get innovation and success without having a few failures along the way. What is so important to those of us in the innovative research field, is that we learn from those failures and harness them into wins.
Wins for patients.
Wins for our Canadian health care system.