Untangling the Mess: From Disconnected Tools to Platform-First in Digital Trials
A platform approach would benefit patients, sites, and sponsors. To embrace wholesale change, we also need to accept that standalone tools will fail to deliver the same improvements.
Expanding patient choice is one important way to increase participation and retention in clinical research, which would undoubtedly lead to better trial outcomes. However, to bring an improved patient (and site) experience into lockstep with operational excellence, biopharma companies need end-to-end visibility of remote patient monitoring, telemedicine, clinical data management, and compliance reporting, to name just a few areas. It’s not possible to achieve this by tinkering with our current processes, given the multiple disconnected applications that don’t share data.
Standalone tools have left clinical teams with the worst of both worlds, generating few gains for study flexibility at the cost of even more operational challenges. Consider a scenario where your team concludes that patient enrollment and retention are best served by offering the option of virtual visits. This would (arguably) improve the patient experience but slow down sites. Introducing standalone virtual-visit technology and processes to the overall mix increases site effort and technical support inquiries. Add to this the slowdown of data flow into the biopharma company and the negative implications of making a standalone investment become clear.
Conversely, adopting a platform approach means that a single technology supports the majority of protocols with enough flexibility to absorb niche trial requirements. This avoids ‘perfect’ becoming the enemy of ‘good’. Rather than starting from scratch each time, operational and technology needs are defined and consistent across protocols, eliminating the need for guesswork. By reducing the thinking time on technology, study teams are able to focus on science instead.
An industry talking at cross purposes
Today’s disconnected approach underlines the gap between ambition and reality in digital trials. The biopharma industry embraced the concept of ‘decentralized’ a decade ago, which sounded innovative but soon became shorthand for any trial using non-conventional technology or processes, no matter how minor their role. More recently, ‘hybrid’ has reappeared, even though few companies are able to deliver on the operational implications of mixing and matching between on-site and offsite research methods. There’s already talk of ‘DCT 2.0’, reinforcing the notion that decentralized trials as we know them today are not working.
The lack of a common vernacular has resulted in the industry talking at cross purposes. Not only is this confusing, but it has also suppressed our ambition. Based on the logic of the FDA’s definition, using electronic Patient Reported Outcomes (ePRO) or eConsent would meet the ‘non-conventional’ label despite being standard tools in many studies. Success in a decentralized trial then becomes how often such products are used rather than genuine progress toward operational excellence or patient choice. To counter this, we argue that the industry needs a patient-centric definition that moves us away from the decentralized moniker.
Flexibility for patients is only possible within the context of operational excellence. This challenges the industry to run trials based on what patients want, depending on their demographic background, health profile, preferences, and how they feel that day — rather than what the technology allows.
Scalable approach to executing trials
Historically, scientific rigor has often been at odds with operational efficiency. Achieving one required tradeoffs from the other, as tools had to be uniquely assembled and integrated for each study. This is despite the fact that roughly 80% of technology will be consistent across all studies. Almost every trial will need tools like randomization trial and supply management (RTSM), electronic data capture (EDC), and eConsent.
A platform approach toward study tools and applications means operational excellence and scientific rigor are largely symbiotic. That’s because connecting these applications allows for a complete and concurrent scientific data review even where the design and execution requirements of a study may differ. Any additional effort should be invested in identifying the 10%-15% of the trial’s requirements that are exceptional to the ‘cookie-cutter’ model rather than rebuilding the core each time. Centralized data ingestion and cleaning are important for tools with high variability (like sensors or telemedicine), so variable data sources can be connected, coalesced, and cleaned on a common platform and with other core trial data.
The benefits of a platform approach go beyond operational efficiency. Ending tradeoffs between different user groups could change the economics of the whole trial. When clinical data, clinical operations, and even medical are connected, biopharma companies can start to address challenges with trial recruitment holistically. Taking an extreme example, perhaps you want to double patient retention, which in turn would allow you to halve planned recruitment time. If investigators and site coordinators are on the same platform and able to communicate (with support from medical affairs), an ambitious recruitment goal becomes much more achievable.
Finally, enabling connected data can also foster innovation by freeing up teams to focus on novel science. Imagine a scenario where your company is moving into a therapy area for the first time or is looking to advance its drug pipeline. The barriers to entry are high and range from scientific knowledge gaps to confusion and discomfort due to study complexity. With a platform, the technology isn’t unfamiliar territory each time, so teams stay focused on the science and on any unique trial elements for that therapy area. Over time, as teams become less risk-averse about innovation, equations of time, quality, and cost will shift in their favor.
More speed, less haste
The industry embraced digital trials when new technology was introduced more than a decade ago for all the right reasons. However, the net result for many companies has been a messy collection of disparate technology. This has made life harder for sponsors, data managers, sites, and investigators without achieving our ambitions of patient-centric trials.
Hoping that we can bolt together dozens of standalone tools for each study isn’t a strategy, especially when speed and quality are our driving principles. Moving toward a common data framework and platform will make it easier to allocate resources efficiently and increase flexibility for trial participants. As the conversation moves on from ‘DCT’, we will focus on a more productive goal: digital trials, where operational efficiency and scientific rigor are in lockstep.
Learn how Veeva is advancing digital trials with the industry on Veeva Connect.