In Silico Modeling & Clinical Trial Design

How In Silico Trial Designs Are Streamlining Cancer Research

Cancer is among the modern era’s most complex and urgent global health issues, claiming millions of lives each year and affecting tens of millions more. It goes without saying that advancing cancer research and developing novel therapies to combat this crisis requires innovations across numerous disciplines, including genetics, cellular biology, and pharmacology, among many others. A key to such innovations is advances in information and communication technologies, which help bridge the gap between disciplines and drive discoveries. However, when compared to other industries, healthcare has been slower to adopt new technologies. Fortunately, this is changing, as evidenced by the increased use of in silico modeling and trial design.

M2GEN—a global leader in oncology-focused health informatics—understands that innovations isolated within disciplines are not enough to drive cancer research forward. Developing the next generation of cancer therapies requires the organization and contextualization of enormous quantities of data as well as interdisciplinary coordination and collaboration on a mass scale. Arising from this need is in silico modeling and clinical trial design: an innovation that M2GEN is making widely available to cancer researchers.

Understanding In Silico Modeling & Trial Design

In silico modeling, within the context of medicine, refers to the development of virtual models of pharmacological or physiological processes that can be used to glean insights into specific avenues of medical research. Similarly, in silico clinical trials refers to the development of virtual patient cohorts that can be used for testing the safety and efficacy of novel therapies, such as drugs and medical devices.

The Promise of In Silico Research Approaches

While still in its infancy, in silico modeling and clinical trials show enormous potential to streamline cancer research and aid in the development of safer and more effective cancer therapies. In fact, advancing this technology can yield untold benefits, including:

Reduced Costs on Research & Development

Undertaking a clinical trial is a financial risk for pharmaceutical researchers. There are substantial costs associated not only with research and development but also in identifying qualified patient candidates and executing the trial itself. In silico modeling and clinical trials mitigate this financial risk by allowing researchers to get greater quantities of more accurate data in early research phases, thereby reducing the likelihood of late-stage clinical trial failures.

Shorter Timelines for the Development of Novel Therapies

As in silico modeling and clinical trial design advance, timelines in all phases of research and development can be dramatically reduced. Virtual cohorts can be used to efficiently gain insight into highly specific areas of research by allowing scientists to quickly adjust variables, adapt models to account for new discoveries, and target nuanced disease factors, such as specific biomarkers and mutations. Ultimately, conducting research within a simulated environment speeds the time to market for new and more effective therapies.

Higher Ethical Standards

There is currently no substitute for in vivo clinical trials. However, in silico modeling is allowing researchers to account for more factors in terms of the safety and efficacy of potential therapies before they are tested on live subjects, decreasing the risk of adverse side effects. Additionally, in silico research approaches make it significantly easier and less costly to closely study rare diseases that may have been overlooked in the past due to financial and logistical hurdles.

Where the Science of In Silico Modeling and Trial Design Stands Now

In silico modeling and clinical trials are still fledgling technologies that are only just beginning to become a mainstream component of cancer research, and the bioinformatics experts at M2GEN are proud to lead the charge. A prime example of this is our ORIEN AVATAR^® Program —the first solution to build comprehensive patient profiles containing phenotypic and genotypic data. ORIEN AVATAR is real-world data (RWD) generated from real-world medical settings with each patient’s identity shielded behind an avatar.

By tracking progressions over each patient’s lifetime, ORIEN AVATAR provides researchers with an incredibly robust, longitudinal data pipeline that is optimized for cancer research with the inclusion of whole exome, transcriptome, and germline sequencing data. This allows cancer researchers to develop in silico communities based on highly specific factors ranging from treatment progressions and disease recurrences to the presence of certain biomarkers and mutations. Indeed, there are endless research applications for the unparalleled data available through AVATAR, including the collection of real-world evidence (RWE) that can be used for FDA submissions to the design of in vivo clinical trials with ideal sets of patient candidates.

Looking Forward

The success of in silico modeling and trial design has indeed been astounding. As a result, regulatory bodies have become increasingly accepting of discoveries generated via in silico modeling and trials. Looking forward, the aim of in silico clinical trial design is to continue to increase the efficiency of research and development while lessening cancer researchers’ reliance on in vivo clinical trials. As we are today, M2GEN will be at the forefront of streamlining cancer research through in silico modeling, helping bring about a new generation of highly effective and targeted therapies.