It’s Time for Sites to “Bring Your Own Technology” (BYOT)
Clinical trials are growing increasingly complex, more expensive, and demand patient diversity. Since 2013, trial objectives have increased by nearly 16% in Phase III trials, with data points collected increasing by more than 300%. In addition, sites are experiencing frustration and confusion caused by the multitude of technologies sponsors require, with an average of six sponsor-mandated systems per trial. Frequently faced with managing different technologies for each sponsor and trial, the administrative burden on sites is enormous.
Let me give you an example. We’ve heard from study coordinators at sites who once reported being able to perform six or seven participant visits a day who now report, it’s down to two or fewer. This stems from the multiple duplicative efforts required to enter data and documents into sponsor-imposed systems that sites often already have collected somewhere else.
At Advarra, we’re out to fix this challenge. Our goal is to create a standardized, seamless integration between sites and sponsors or contract research organizations (CROs) – ultimately creating a site-centric connected ecosystem of technology supporting clinical trials. Because, at the end of the day, sites and sponsors have the same goal: bringing treatments to market safely and efficiently.
Here are a few things to know when it comes to Advarra’s BYOT philosophy:
Ensuring Patient-centricity Starts with Being Site-centric
A recent survey led by Advarra and the Society for Clinical Research Sites showed that over 60% of sites report sponsor-provided platforms or portals have increased their operational burden significantly. This is a problem for both sites and participants. When sites are overburdened, they can’t provide clinical trial participants with the level of attention they need, resulting in a lack of overall patient-centricity and an increased risk of participant dropout.
Sites play a central and pivotal role in clinical trials, but their input is often overlooked. Sites must be able to use their own integrated technology to efficiently support both site and sponsor workflows. One of the places where we see delays in clinical trials is study startup. Miscommunication between sites and sponsors is often why these delays occur. This is unfortunate because study startup time is critical to participant well-being, especially those with life-threatening diseases. By seamlessly connecting site and sponsor systems and reducing duplicate workflows, BYOT decreases startup time, accelerates research, and allows stakeholders to bring treatments to market faster.
I’d love for participants to feel more engaged with the research team, because clinical research is, of course, not possible without willing participants. Enabling research coordinators to spend less time entering data and more time with participants will allow them to feel more engaged and a part of the wider team. This can also have downstream impacts to improve recruitment activities, patient consent workflows, and much more.
Sites and Sponsors Both Benefit from a Connected Technology Ecosystem
Technology must be connected and collaborative for sites and sponsors to be most effective. When sponsors prioritize their own needs, sites must take on new administrative tasks, distracting from their ability to focus on process improvement and participant well-being. Our survey with SRCRS also found that 28% of sites spend more than 15 hours a day interacting with multiple, disparate systems, issued to them by the sponsor or CRO; yet 86% of sites prefer to use at least some of their own technology solutions to manage and conduct industry trials. It’s also worth mentioning only 8% of sites prefer to use all sponsor-issued technology.
Sponsors, like sites, are doing the best they can. They have their own processes and vendors working to centralize information across growing global teams dealing with increasing workloads, variable regulatory and data security requirements. The current process isn’t ideal for anyone. That’s why at Advarra, our goal is to standardize and integrate actions, data, and documents between sites and sponsors to make their work more productive.
Sponsors will also benefit from the connected technology ecosystem: Enabling sites to use their own technology allows sponsors to connect with existing site technologies to exchange documents, conduct remote monitoring, track enrollment, and more. As an example, automated sponsor visibility into which documents a site has already uploaded can save a significant amount of time. Sites would only need to upload new documents as a result. This is only one example of how an intelligent, connected ecosystem can be a huge time saver.
BYOT will benefit all research stakeholders from sites to participants, making safer, smarter, and faster clinical trials a reality. We need to start challenging the existing norm for clinical trials because they’re growing more complex. This calls for a process solution, not a point solution.
At Advarra, we passionately desire to have more patients look at research as a viable care option and encourage more clinicians to recognize the value in clinical trials. The increasing momentum around patient-centricity and innovation in clinical research means the time is now to reform and strengthen the site-sponsor relationship.
The BYOT initiative feels like a natural extension of what we’re already working on at Advarra. We play a role in more than 60% of all industry clinical trials and see firsthand how impactful clinical research is. There’s an opportunity to make clinical research easier for those involved, and more effective for those who rely on it for life-saving treatments, and that’s what matters to me.