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July 25, 2016

Simulation is Revolutionizing Clinical Trials

Mark Campbell

In the evolving world of medicine, clinical trials are used to gauge the safety and effectiveness of new medical devices, procedures, and medications.

However, they aren’t a perfect science.

Clinical trials can be costly, risky, and produce different results than when the treatment is applied in the real world.

According to a 2014 report prepared for the U.S. Department of Health & Human Services, certain types of clinical trials can cost up to $115.3 million per study. With thousands of new studies being conducted each year, costs of clinical trials are fast approaching an unsustainable level.

Source: U.S. Department of Health and Human Services, 2014

Source: U.S. Department of Health and Human Services, 2014

Researchers are now leveraging advanced simulations to enhance these trials, working to protect participants, increase the likelihood of reliable test results, and uncover benefits and risks associated with new developments. Today, simulations backed by high-performance computing (HPC) technologies are merging data from historical trials, electronic health records (EHRs), and patients themselves to conduct realistic and cost-efficient virtual studies. An initiative called the Living Heart Project is working to harness these large volumes of medical data in order to produce the world’s first 3D models of the human body, enabling researchers to develop more effective medical devices, drugs, and procedures than ever before. The Project’s most recent innovation includes the Living Heart Human Model, which has advanced the use of simulation to deliver safe and effective cardiovascular devices and clinical treatments.

Big Data is key to furthering modeling and simulation techniques, allowing medical professionals to hone in on evidence rather than assumptions to make more accurate medical decisions. Because predictability is a fundamental component of clinical trials, researchers rely heavily on predictive models to identify implications across a range of assumptions. Realistic simulations have become essential and developing breakthrough medical advancements as researchers use them to replicate a variety of conditions in order to predict the likelihood of a successful treatment outcome.

Pharmaceutical companies are one faction benefiting significantly from these innovations. In a study conducted by the Association of the British Pharmaceutical Industry (ABPI), pharmaceutical researchers are investing huge amounts of time and money into medicinal trials; however, only 10% of medications are ever approved, and the developmental process can take nearly a decade. Thanks to advanced analytics and modeling, virtual models can now be used to monitor the body’s response to experimental medications in real-time. The ability to simulate clinical testing not only saves valuable resources, but it also allows pharmaceutical companies to streamline trial design, investigate a wide range of variables, and improve outcomes, which speeds time-to-market.

To implement a well-informed simulation strategy, Applied Clinical Trials notes that medical experts must eliminate “traditional research silos” that inhibit data sharing. Successful practices encourage collaboration between development experts from various disciplines. Their combined knowledge ensures that simulated testing will support accurate, well-researched findings throughout the trial.

The explosion of Big Data is rapidly transforming the way the medical research community performs clinical trials. Researchers are using data-driven simulations to observe the effects of drugs, treatments, and procedures, thereby minimizing risks to trial participants and quickly identifying and replicating positive outcomes.

Modeling and simulation techniques are at the very core of the breakthrough capabilities of medicine, offering endless possibilities not only for scientific discovery but for an increased quality of life.

Datanami