When we start to talk about the use of open source technologies in life sciences, leaders fall into two main groups of thought: either we’re going all in on open source, or we’ll never compliantly be able to.
For the former, diving in to open source is exciting in the pursuit of building a more efficient life sciences ecosystem. From molecule discovery to trial enrollment and every step in between, the idea of using open source for innovation, increased speed and improved drug delivery is top of mind for many research teams.
At the same time, the latter group of thinking is still present: in order to maintain regulatory compliance, open source seems like a nonstarter. How could we include open source technologies in drug development, the most highly regulated industry in the world, without posing risks to patients, patents and to the teams developing lifesaving products?
In between those two ideals, we can find a common ground.
The wave of open source in life sciences
Regardless of initial reactions to open source, we know one thing is true: open source has been a part of drug development for years and is now coming ashore in more regulated processes.
To stay ahead of the curve, teams across pharma, biotech and clinical research need to act now to prepare for open source integration and ensure the right statistical environments and risk mitigation processes are in place to support their clinical development work.
Using open source tools and technologies will not be an easy on or off switch in the analytical frameworks of drug development teams. Rather, the open sources tools and programming languages being presented should reflect a strategic, audited use case intended to increase the speed of drug development and delivery without risking safety and efficacy of the therapy. Just as we saw in the wave of decentralization and decentralized clinical trials (DCTs), we’ll see in this wave of open source technology that a focus on safety, compliance and auditability of data and analytics are critical indicators in drug approval.
Where to use open source in pharma
Specific use cases of open source are still being tested and vetted. From what we currently see in the market, several adoptions of open source are currently possible, with more on the horizon.
For example, it is possible to use open source language for preparing clinical study report results, but attention needs to be paid to embrace a truly open approach, whereby technology is evaluated on how suited it is to reach the objectives (e.g. producing clinical study reports robustly, flexibly in validated environment) rather than on personal preferences. In this example, what we see isn’t a full dive into open source alone, but rather a balance of using open source and still maintaining industry standards.
Often a hybrid approach to include some open source languages or capabilities inside existing frameworks is safer than a complete overhaul that puts your product at risk of failure or regulatory rejection.
Innovating while ensuring compliance
Open source presents an incredible opportunity to enrich approaches to generate clinical study results and engage a larger community. In theory, patients could receive the life-saving therapies that they need sooner, and organizations can deliver products to shelves with increased speed. In order to do so, researchers need to guardrail their use of open source and limit it to an analytics environment that can be trusted.
One of the best ways to ensure compliance is by using an analytics framework, or a statistical compute environment (SCE), that can maintain various data streams, integrate diverse and disparate sets of information and provide auditability and traceability throughout your analytics process.
In tandem, ensuring that your environment is validated and compliant against Good Clinical Practice (GCP or GxP) standards is an absolute requirement when analyzing active trial or study data.
The future of open source is hybrid
When organizations discuss their analytics journey and their use of open source in life sciences, I encourage you to lean in and to get ready to embrace it where it makes sense. At the same time, I encourage you to question your current systems and frameworks.
A hybrid approach that embraces open source languages and is built, managed and guarded in a secure framework, will allow sponsors and study teams to bring in open source and still maintain regulatory standards.
No longer do we need to fall into opposite groups of thought around the use of open source – the future is hybrid, and our ability to have the best of both worlds is at our fingertips.