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Keys to Unblocking the Innovation Bottleneck in Research

Is the clinical research industry winning or failing at innovation? It probably depends on who you ask and likely full of nuance. In the past decade, trials have evolved to include not just traditional drugs and medical devices, but also innovations like cell and gene therapies, wearables, and more. As exciting as that growth may be, it invites more complexity. Despite the fast pace of medical innovation, the lack of consistency between technology systems managing these advancements ultimately inhibits research progress.  

As the clinical research industry has evolved, so have the many vendors looking to solve point solutions. While some have legitimate use cases and widespread adoption, the sheer volume have created a new bottleneck to achieving innovation in clinical research. In the funnel of transformative solutions, we see too many solutions stuck in pilot mode after a key case study or two, with few solutions trickling into transformative and driving toward faster treatments. 

As sponsors have adopted technology designed to support automation, document management, and data collection, research sites have also continued to grow more sophisticated in their approach to data and operations management. Between the required sponsor platforms and their internal systems, that is a lot of redundancy, duplicative workflows, frustrated staff, and wasted time.  

Site staff are spending between 10-20+ hours per week just on data entry into sponsor-provided systems. They indicate at least half of this is duplicate data that is otherwise already tracked in sites’ own systems. Imagine if we declared every Monday “Duplicate Data Entry Day” for all sites everywhere. Has innovation really succeeded in clinical research if this is the state we’re currently in? I believe our industry needs an intervention. 

While the numbers above don’t inspire confidence, I believe we are on a path to success, allowing for more innovation and site centricity. The good news is people are talking about the gaps in innovation and site centricity now. Sponsors and sites are more aware and have improved collaboration to address these challenges. More notably, discussion is reversing the pendulum from continued release of more technology solutions, to connecting them to do better with less. Here are a couple of shared ideas, their downfall, and a proposed alternative. 

Idea: Commit to single platform solution 

Challenge: If there were a single platform vendor across all stakeholders, admittedly it would be easier to communicate and exchange information across all stakeholders. However, like all monopolies, it would extinguish innovation due to lack of competition. The solution is not to consolidate all sponsor tech to a monolith single company. We need new technology and new companies to push the envelope, drive innovation, and think differently to keep us moving forward as an industry. 

Idea: Use only site technology instead of sponsor technology 

Challenge: Without some sort of standardized data and visibility at the sponsor level, sponsors would not get on board, and it would make their work impossible. The solution is not to completely flip the switch and have sponsors no longer choose any technology and instead log into each site’s technology. By completely pushing to the other end of the spectrum, we add cost and burden to the place where it directly drives up costs for the patient in the end.  

How can we Innovate While Reducing the Burden on Sites and Improving Outcomes for Sponsors? 

Our answer is to centralize, standardize, and integrate. Centralize sponsor/site collaboration into a single portal and integrate as many touchpoints as possible. Create and use standards wherever we can.  

How can we do this? Let me explain. 

We need to recognize there are items that need to be consistent on the sponsor side, as well as on the site side. There are many touch points between sponsors and sites, and everything must work together for a trial to be successful. For example, the sponsor needs clinical data in a format consistent across sites to run statistical analysis and drive to expedient FDA approval.  

However, does this mean if we want source data directly from the electronic health record (EHR) system, the sponsor chooses the site’s EHR? Of course not. This is where standards become the key to bridging the two sides. Sites have their own systems for source data entry (including, but not limited to, the EHR) and sponsors have their own systems for clinical data such as electronic data capture (EDC), a central clinical data warehouse, etc. CDISC has paved the way for this model through ODM, CDASH, and CDISC standards. 

The same process applies, and is more commonly used, for regulatory documents. Sponsors use their own electronic trial master file (eTMF) system across all studies to remain compliant. Sites use their own electronic investigator site file (eISF) system for the same reason. The solution is not for sponsors to require sites to use a sponsor-approved eISF. That is not best practice for the same reason a sponsor wouldn’t use a separate site eTMF for a single part of a study. 

Advarra has made headway on this through recent launch of the Secure Document Exchange, driven by the Advarra Site-Sponsor Consortium. CDISC is now working within the consortium to develop standards much in the same way, so we can enable integrations across the board.  

We are highly orchestrating these two use cases and working very closely with sites, sponsors, CROs, and CDISC to make the connected research ecosystem a reality, continuously forging our way down this highly collaborative path empowered by integrating both sides of the clinical research spectrum. 

When we work collaboratively, there are many more use cases providing opportunities to ease sites burden. Technology integration is key to enable site-centricity at scale. 

Though it may not be well known among many industry colleagues from sponsors and CROs, sites invest in their own technology. It’s true – most sites now leverage a clinical trial management system (CTMS) to manage their research operations. These systems, built specifically for sites, help them across their entire research portfolio, regardless of the sponsor. In the past few years, additional site technology has been more widely adopted, including eReg, eSource, televisit capabilities, eConsent, and more. This is important context for why sites are pushing back on using any sponsor-driven tools duplicating these same capabilities but only for a single trial.  

Our article, It’s Time for Sites to ‘Bring Your Own Technology’ (BYOT) outlines why site technology is so important for sites.  

Now, let’s fast forward a few years (or decades, depending on your level of optimism), and imagine a site has technology they have optimized, trained all of their staff on, and automated across all of their operations. Imagine the site can go to their own technology and see all of the items they need to tackle for all of the studies they are assigned to, watch refresher training videos on protocols and the technologies they use, document protocol or participant progress once and have it automatically sync with sponsor systems, and trigger next steps and downstream billing workflows. Imagine a new innovative technology is developed, and a sponsor wants to use it for new trials. If it’s integrated in with that same site tech platform, the burden is drastically lower on the sites and thus can be rolled out and adopted with key stakeholders (the sites) to maximize the technology’s potential. 

To make this a reality, we need to forge a new path of site-centric integrations, standards spanning stakeholders and centralizers of clinical research. We are working hard to enable site-centric integrations at scale through the Advarra Site-Sponsor Consortium and through our API Partner Program. Both are aimed at leveraging existing site technology, and provide value to both sites and sponsors through integrations. 

I truly believe if we can integrate with site technology and standardize integrations, we can innovate much faster as an industry. Join us in helping create a better-connected future. 

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