The disconnect between clinical trial technology and legacy habits
In today’s age of cloud computing and data integration solutions, there are simple and logical ways to successfully support clinical research. Yet the technology approaches I see being used are, at the core, technology archetypes that are 20 or 30 years old. It seems that we as an industry have held onto a technology mindset that is no longer serving our needs.
Why are study builds the same as decades ago?
Let’s explore electronic data capture (EDC) as an example. If your study requires EDC, you are more than likely looking to run a global study that includes a variety of data sources, including direct from investigator/provider, laboratory data, adverse event, and medical codable data. Possibly also eConsent and some data direct from system (i.e. eSource) — and you’ll want to ensure any data that was entered into the EDC by the provider’s research team is accurate and true to source.
If you were standing this study up 20 years ago, you would need an EDC and a separate clinical data management system (CDMS), plus a plug-in lab normal solution and medical coding solution. Also a system that integrates direct data feeds from multiple sources, and finally an eConsent, which didn’t exist then but if it did, a separate eConsent solution.
If you stop to consider how things are executed today with the major systems in use by many sponsors and their sourcing partners, this should sound hauntingly familiar. Not a huge amount has changed. Given the pace of technology change and adoption in all other aspects of our day-to-day lives, it fascinates me that we see this as an acceptable way to support clinical research given today’s capabilities.
This “plug-in” approach to technology is also getting more costly and less efficient, requiring a significant amount of human intervention to enable end-to-end data flow. Given that trial designs are becoming more complex, the need to be flexible and reactive to unique trial needs is absolutely critical to success. However, each new piece of technology needed to support these complex research needs, including adaptive and decentralized trials with more new and novel data sources, requires more effort to enable and execute rather than reducing resource demand — moving the effort around versus actually eliminating it.
It’s time to move on to a better way
What we have not scaled out as an industry is true adoption of modern cloud technology architecture and solutions. Think about your day-to-day life. If you want to see your complete healthcare record from your primary care provider or conduct financial transactions, you typically expect to log into one website to gain access to all your information. Having to physically go to brick-and-mortar location or to an alternate digital site is hopefully the exception, not the norm.
However, as new technology needs surface to conduct trials, we continue to look at the next data capture or analysis challenge with the perspective that we need to “plug in” another piece of technology rather than approach the entire process through the use of a truly unified platform. This label can be tricky as well: If solutions claim to be a “unified platform” and yet still require significant investment in system integration, it might be time to stop and question why.
At Merative, we believe there is a better way to solve today’s and tomorrow's complex research challenges. More than 10 years ago, our clinical development platform, Zelta™, began as a truly unified, cloud-hosted solution that’s built on a single code base instead of plugging in technology pieces and parts. We understood that clinical research was getting more complicated and each research study has unique needs. We believe that an optimized system to support research has to be fully integrated with true end-to-end data flow, along with the ability to activate features and functionality (like labs, medical coding, eCapture, etc.) at the study level. Why pay for technology at an enterprise level if you only need it to execute a portion of the portfolio? Cost and functionality should align with consumption and need.
Zelta is being used to successfully support all phases and complexities of research, proving that it is possible to make it easier to execute the complex — and that doing so delivers differentiated outcomes. All we have to do as an industry is move beyond our legacy understanding and seek a better way.
See how LivaNova used Zelta to build a unified CDMS platform designed for ease-of-use at all project stages and offering cloud-based flexibility. Read the case study.