Clinical trials are incredibly complex undertakings, and they’re only going to get more complex and harder to manage in the coming years.
That means research organizations, sponsors and trial directors all have a pressing need to find new ways to make their trials run more smoothly, says Ken Getz, director of sponsored research programs at Tufts University Medical School. And most of the easy fixes have already been fixed, he says, which means true innovation will be necessary to manage those increasing complexities.
These are the kinds of innovations that must improve every part of a trial’s life cycle, from vendor management to participant engagement.
Here is an overview of how those innovations are developing right now.
Patient Collaboration Tools
One area where technology is helping clinical trials take great strides is in participant communication. A whole host of apps and platforms are giving participants a louder voice, patients with specific conditions a chance to speak up and patient advocates a way to make connections.
What this translates to is a “democratization of information,” clinical researcher Ryan Bailey says. And this mirrors a lot of what we’ve been seeing on the care provision side of the healthcare sector. Just as patients have learned to use information available to them to learn about their conditions and come to their physicians with questions, Bailey says, clinical trial participants expect to be able to collaborate with researchers, not simply act as passive participants in a study.
A few companies have stepped in to facilitate that kind of collaboration:
- HealthiVibe has created an end-to-end survey platform called HealthiPerspectives that gathers more robust participant feedback over the duration of a clinical trial, and even after the trial is finished.
- Antidote makes it easier for people to find clinical research studies that are relevant for them.
- Transparency Life Sciences is involving participants even earlier in clinical trials. That platform helps connect patients with specific conditions to researchers who need more context and more information to design their trials.
Granted, the flow of such democratized information requires diligent management. Collaboration only thrives within a sound structure. That’s why companies such as Parallel6 and Longboat are building platforms that help all stakeholders connect with one another. That way, crucial pieces such as consent forms and notifications get to the right person in a timely manner. As Longboat puts it, having an integrated dashboard “engenders a greater ‘sense of team’ across these key groups.”
Trial Access Tools
What Transparency Life Sciences and similar platforms are doing is pretty remarkable — and might have been unthinkable a generation ago. But getting patient input so early in the process addresses an important issue.
According to research from the Avoca Quality Consortium, many patients feel their providers don’t have “a very good understanding of what it was like to be a patient with their condition.” By giving these patients a platform to share their challenges, a way to track their conditions and even the words to describe what they’re experiencing, clinical trial directors are opening up whole new avenues of research.
And they’re engaging completely new patient populations with the help of patient advocates. For example:
- CureClick has built a platform that helps people representing condition-specific online communities get the word out about relevant trials.
- WEGO Health engaged a variety of stakeholders — from startups to CROs to government organizations — to create customized processes for collecting these patient experiences and translating that information into trial development.
Raising awareness about trials in patient communities is one thing, but getting those patients to actually participate in a way that’s convenient for them? That requires another level of management.
Some of the tools facilitating this kind of access are familiar enough. As Forte VP of Marketing Mel Johnson notes, ride-sharing platforms like Lyft and Uber are great for getting participants to a trial site.
But another frontier that companies are exploring is siteless trials. These take place in digital realms rather than physical ones, so access isn’t limited by the convenience of getting to a trial’s site, only by a patient’s ability to access the required technology. “Siteless trials tear down geographic barriers, opening up trials to a much wider – and potentially more diverse and representative – patient population,” Eye For Pharma writes in its 2017 Trends in Data and Technology report. “By harnessing wearable technologies and mHealth, such trials offer the allure of not just enhanced data quality but better data volume through continuous monitoring.”
Vendor Management Tools
On the other side of the clinical trial lie the vendors and suppliers. In other industries — retail, for example — you will find whole teams of logistics professionals to manage supply chains. In many clinical trials, however, vendor management has often been treated as a task rather than a role.
That’s a problem in the face of growing complexity, says John Carlos Diaz of GeoSera Consulting. “[M]any of the clinical staff tasked to manage vendors in a clinical trial lack experience managing people, especially managing people who do not directly report to them, such as outsourced vendor staff,” he writes at Clinical Leader. “You can imagine that managing indirect staff from a vendor can be a delicate and challenging responsibility.”
Again, a new generation of tech tools are helping clinical trial teams navigate that responsibility. These include:
- Slope.io, which helps trial directors predict the demand of lab kits and restocks those supplies in such a way that it appears seamless
- Cenduit, whose interactive response technology (IRT) ensures that a trial site never runs out of stock
- Endpoint, which offers an IRT service to help trials maintain the supply stocks they need as well as a sponsor-level portfolio management tool for organizations that are organizing several trials at once
Of course, technology is only part of the efficiency equation. As Kayla Fargo at Forte writes, technology is only as useful as the people and the processes it supports.
For a CRO or a pharmaceutical company with the right team and the right processes in place to scale as needed, the right software can provide the support necessary for a clinical trial — from Phase I on through to Phase IV — to meet the challenges of an industry facing ever-increasing complexities.
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