How Open-Source Benefits Clinical Trials

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Many recognize that clinical trials can benefit from transformation–namely, digital transformation. For decades, various segments of this domain were unchanged. However, the acceleration of remote and digital engagement driven by factors such as the pandemic and the evolution of customer expectations has sparked a flame of innovation in the industry. Today, most plan to implement new technologies and adopt clinical trial models that are more patient-centric, as seen in the push for decentralized clinical trials (DCTs).¹

There are new technologies, particularly open-source software, that will infuse much-needed innovation into clinical trials.

Why innovation is so important in clinical trials
Innovation is critical to getting more personalized and targeted medicines to market. In fact, the FDA encourages it, as seen with its release of two discussion papers² that promote the use of AI and machine learning (ML) in drug development and manufacturing. With the FDA giving life science companies the proverbial green light, many are eager to pursue new approaches.

However, buying and implementing standard commercial off-the-shelf (COTS) software will not be enough to drive disruptive innovation. It usually takes longer for software product vendors to make changes if proprietary COTS software must adapt to meet unique and emerging requirements. Life sciences companies may have no choice but to customize the software (if they even have the capability) to meet their needs. As a result, the resultant software is usually harder to support, upgrade, and maintain.

Open-source software, however, is well designed for innovation on the edges and for users to adjust and tweak it to meet their unique needs. One of the biggest benefits for life sciences, new therapies, and the patients that need them is that innovations in open source software make it back into the base code for others to benefit and build from.

How different industries, including life sciences, use open source
From consulting and education to healthcare and finance, many industries use open-source technologies to fast-track project starts, achieve greater flexibility in software development processes and decrease costs. Life sciences companies already utilize open-source technologies as a foundation for unlimited commercial and academic applications.

One such tool is ACUITY, released last year by the digital Experimental Cancer Medicine Team through the Cancer Research UK UpSMART Accelerator Consortium. ACUITY helps visualize clinical trial results in near real-time, permitting leaders to suspend unsuccessful trials sooner and redistribute resources saving time and money.

Other ways open source will benefit clinical trials
In clinical trials, open-source technologies have allowed companies to accelerate the discovery of novel drugs or biologics while repurposing new molecule entities or currently approved drugs, such as AstraZeneca’s REACT program.³ These technologies can also speed up and proliferate innovation for cell and gene therapies, which is beneficial as there are no mature COTS tools in this space yet. At the same time, this software can help facilitate discoveries in areas lacking investment or resources, like vaccines, antibiotics, and macrophages.

Other areas where these tools are likely to enrich clinical trials are the next generation of targeted medicines that use genetic biomarkers and variants to make therapies more effective for select people and populations. The processes surrounding these personalized medicines are often very data–and analytics–heavy and will benefit from emerging technologies that have yet to make their way into mature COTS solutions.

The future of clinical trials
As we stand at the threshold of the next generation of therapeutics, namely those that are more personalized/targeted as well as administered in new ways such as cell and gene therapies, innovation is required; such that the clinical trials process and ecosystem largely rooted in historical ways of working will not slow time to market down, but really speed it up.

The unique advantage of open-source software for clinical trials is community support and collaborative innovation where each build on top of another. Taking advantage of open source allows organizations to benefit from the work of the entire community who use the same tools, overcome similar issues, and share their best solutions to advance digital technology and, as a result, healthcare.

Greg Killian is VP of Life Sciences at EPAM Systems, Inc.

References

1. FDA Takes Additional Steps to Advance Decentralized Clinical Trials. FDA. May 2, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-steps-advance-decentralized-clinical-trials
2. FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing. FDA. May 10, 2023. https://www.fda.gov/news-events/fda-voices/fda-releases-two-discussion-papers-spur-conversation-about-artificial-intelligence-and-machine
3. Proffitt, Allison. Building a Tech-Enabled Drug Discovery Pipeline at AstraZeneca. Bio ITWorld. June 7, 2022. https://www.bio-itworld.com/news/2022/06/07/building-a-tech-enabled-drug-discovery-pipeline-at-astrazeneca