One of the biggest complaints about the U.S. regulatory system is that the clinical trials required to prove safety and efficacy are prohibitively expensive.
But could technology help to justify that cost or reduce costly errors related to clinical trial design? Or, better yet, eliminate clinical trials completely?
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
Dr. Michael Smith, staff doctor, clinician and community liaison with Life Extension of Fort Lauderdale, Florida, believes that the former is possible as the use of supercomputers become ubiquitous. Completely replacing them is the dream of people developing such technology, he noted.
Smith talked about current applications of clinical trial simulators using these supercomputers that can crunch data in a matter of minutes. Here’s an edited version of his example:
Let’s say I want to do a study on the effect of vitamin C on the heart. In order for me to have any decent results, I would have to have 10,000 people in this population set. That’s very expensive. Before I even worry about raising money, I can use these supercomputers. I can basically put all of the real-time factors into the computer simulator — 10,000 people, from the age of 25 to 65, middle income people, what your dosing is whatever your parameters are going to be — and based on past experience, the computer will take the information and pretend that you’ve done the trial.
The computer will be able to produce results that are as accurate as what you would get if you actually did the trial. That’s the processing power of these simulators.
The hard part would be to enter all the correct data in that the program would analyze — the average blood pressure, the average heart rate.
So before I invest all that money in a clinical trial, the computer will tell me “Dr, Smith, this looks like a really good study. You should get good results out of this. Based on the computer simulations, we see that heart function will improve [say] 22 percent.
This result, as a researcher, gives me the confidence to go to grant companies and say look what I have here. It’s kind of a safer investment.
Smith said that initially these supercomputers powered by clinical trial-simulating software will be able to say whether a clinical trial should be conducted or not.
“However, if you talk to scientists developing these technologies, [it] is that ultimately, they believe later on in the future, these supercomputers will be able to conduct trials in a virtual environment and produce such accurate results that you don’t even have to do the trial. So based on how great these supercomputers are, we will be able to trust that data and assume that research was done and act on that research right away.”
That sounds very futuristic and will undoubtedly require some heavy duty convincing of regulators. But then, 20 years ago, did anyone think that a phone would be able to function as a portable ICU monitor?
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