– Written by Anonymous, an Open Source sceptic

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With many companies turning to open-source solutions, with an eye towards innovation and advancement for clinical trial analysis and reporting, I have to ask – why? What’s in it for companies and for programmers? There have been increasing presentations on the use of open-source technologies at the PHUSE US Connect over the last three years, resulting in “Open Source Technologies” being added as a Stream at this year’s EU Connect. So, what’s all the hype about?

Proponents of open source will tout the usual business buzzwords – time, cost, efficiency, collaboration, quality, talent – but do open-source solutions really provide these benefits or are they just a different way of achieving the same outcomes?

Let’s break it down:

- Time and Cost: If a company has spent years building up systems and programming, switching to an open-source solution could involve significant time and costs. Even if the open-source technology is available for “free”, there are costs associated with setting up your computing environment and training users. There can be a huge learning curve involved with switching to a new programming language or technology. I’ve heard this compared to learning how to write with your non-dominant hand, which is no easy feat. The additional work to move to and learn new solutions could result in delays to studies, potentially impacting on patients.

- Efficiency: Some will argue that open-source technologies handle large volumes of data better, but there are plenty of proprietary systems that can handle big data as well. Additionally, open-source solutions are supposedly more efficient since they are developed once and made available to multiple users, reducing the need for every company to develop their own solution. This may improve efficiency if everyone were using the same open-source technologies, but with multiple languages and applications in use, this wouldn’t necessarily improve development efforts. Furthermore, some degree of customisation is likely needed to implement an open-source technology at individual companies.

- Collaboration: If everyone is working together to share the development and validation effort and using the same solutions, doesn’t my company lose some of its competitive advantage? Additionally, if we identify issues with an open-source technology, we’re then dependent on an external party to fix it, which may not happen within our target timelines. Proprietary software companies provide service-level agreements, so I can rely on getting issues addressed within a certain timeframe.

- Quality: Just because something is made available as open source, how do I know it is fully validated and the results will be correct, particularly for use in a highly regulated environment such as ours? When I invest in a proprietary product, I know it has been vigorously tested and full-system documentation will be provided. Open-source solutions may have different levels and quality of documentation available, and developers can’t be audited in the way commercial software vendors can. Ultimately, it is the company’s responsibility to ensure any software they use is validated and regulatory-compliant.

- Talent: With recent graduates typically having more experience with open-source technologies than proprietary applications, a greater talent pool may be available to use and support open source within a company. Open-source proponents will also cite that less training is needed for new hires if they have already been exposed to clinical trial work using open-source technologies. However, companies may not use the same technologies or may have different set-ups and processes, making a switch from one to another less than seamless. Furthermore, if I already have a solid team of experienced programmers who are comfortable working in the company’s proprietary systems, switching to new systems may result in attrition and loss of valuable experience.

Thus, I remain sceptical that switching to open-source solutions provides the gains so many are excited about.