Are Computer Simulations Better than Clinical Trials?

computer simulation clinical trial

We may not be able to predict the future, but we can get a glimpse at something that hasn't happened yet, thanks to the miracle of technology.

With computer simulations, it is already possible to track how a pressure injury is most likely to develop once the first signs have appeared, and how it would respond to all variables - something that would be virtually impossible to test in clinical trials alone.

That, according to Dr. Amit Gefen, professor in biomedical engineering at Tel Aviv University, means that the field of injury prevention can grow in expertise quickly and more accurately.

"If a car company wanted to develop a new type of a car, it could design the car, crash it against the wall, improve it, crash it again, improve it, and end up, 10 years later, with a great car," he said. "But instead of just crashing, today, they use computer simulations to ensure that they’re not just burning money.

"We should adapt the same concept and use computer modeling as a complimentary approach to clinical trials, much like they’ve been used in other fields of medicine such as orthopedics and cardiovascular."

Dr. Gefen noted that the FDA requires extensive computer trials to test variables before approving implants such as stents and heart valves. He said it's possible to test "a huge variety of virtual scenarios on the computer, and you can make sure your design can cope with whatever can happen in the body, including a fall."

How Computer Simulations Push Research

Since it’s virtually impossible to run a sufficient number of clinical trials that take into account all of the different situations health workers encounter when trying to prevent or treat pressure injuries, computers offer a reliable shortcut.

According to Dr. Gefen, computer models have a number of distinct advantages for wound prevention and treatment:

  • Visual inspection of the skin does not reveal enough information. The damage often starts on the inside and works its way out. “We cannot just look at the skin and know everything," he said. "That’s why there is so much emphasis on developing SEM scanners and other technologies."
  • Modes of action of medical devices designed for prevention are, in particular, difficult to test in clinical settings, given that studies are costly and require large group follow-ups for extended periods of time.
  • Computer simulations are complementary to clinical research in providing additional important insights regarding etiology, and in demonstrating mechanisms of action of potential interventions.

"No field in medicine is based on visual assessments as much as wound care," he said. "But that is going to change," he added, noting the progress being made in the area of early detection, closer to the cellular level.

Making Treatment Decisions Better and Quicker

In the last 20 years, researchers have learned that PIs do not progress in a linear way from mild skin irritation to devastating wound. They develop through different pathways. More serious cases typically develop from the inside out.

Computer models can help researchers track the most likely course of cell damage from the earliest point to the real outbreak of a pressure injury.

But can they help facility managers make decisions that will cut down on occurrences of pressure injuries?

The answer, according to Dr. Gefen, is an emphatic YES.

With stimulated tests, he said, decisions in many areas, including funding for research and development as well as product purchasing, can be made objectively using quantitative measures.

“The field of pressure injury prevention cannot rely on clinical trials alone to reach new breakthroughs”, Dr. Gefen offered. "There are some fields, like cancer research, with resources that include large pharmacology companies that can fund randomized clinical trials in the billions over many years. They can make the investment and come up with new solutions. But the field of wound care isn’t big enough or strong enough to rely on randomized clinical trials.

"Multi-disciplinary teams integrating clinical and bioengineering expertise and close collaboration between academia and industry continue to push the field forward, for the benefit of patients,” Dr. Gefen concluded.

The Future Will Be Simulated

Technology is already being marshaled for the advanced treatment of pressure injuries and to develop tools for early detection. With computer modeling, today's computational power is being harnessed to learn as much as possible, test every manner of solutions, and arrive at a series of best practices that would take decades to achieve through clinical trials.

The power of bio-engineering is only beginning to impact the field. What's important is to use the gifts of technology and not to dismiss them as inferior because the results they produce are from simulations rather than actual trials. The two areas are increasingly complimentary.

We can, indeed, see the future. The question is what we do with the information.