COVID-19 has placed renewed urgency on updating clinical trial processes with digital and remote functionality. No-code will help make it happen.
Even before COVID-19 prompted an unprecedented rush for new vaccines and treatments, it was clear that many existing clinical trial processes were technologically outmoded. Now that the world is depending on the life sciences industry to take this virus out, these operational relics—with all their inherent inefficiencies—have come front and center.
If only one positive thing comes out of this pandemic, it might be that the urgency of the moment compels the industry and its regulating bodies to finally implement some long-overdue technical upgrades.
A transformation of this scale, however, is no easy undertaking. The good news is the industry has access to tools that weren’t available even a decade ago. Enterprise no-code application platforms like Unqork empower organizations to build complex, scalable digital solutions with a fraction of the resources it would take using a traditional code-based approach.
Inertia, Meet Urgency
While most sectors have embraced the gospel of digital transformation, the clinical trial model has remained curiously unchanged over the past 50 years.
Trials remain reliant on in-person engagements, on-site trial monitoring, paper documentation, and manual checkpoints throughout the process. There are valid reasons for this orientation—many therapies must be administered under the care of a clinician in a hospital or clinic, and many clinical measurements (e.g., 12-lead ECG readings) are best gathered in a clinical setting. Clinical trials also require tight control around the processes of administering therapies, taking measurements, and evaluating symptoms so that safety and efficacy can be assessed.
Watch the replay of our recent webinar featuring Unqork's Head of Healthcare Kara Dennis exploring how and where no-code can be applied in clinical trials.
Digitization is also made difficult by the inherent specificity of the trial process. Trials vary in many pronounced ways due to differences in patient populations, medications, medical centers, available technology, etc. This variability means software must be tailored to address the needs of individual trials, which isn't always easy using traditional development approaches (more on that below).
There's also a general level of understandable risk adversity when it comes to clinical trials. After all, these trials are scientific experiments on humans with their consent, and so care must be taken to ensure that this responsibility is handled with a deep respect for those individuals. For many decades, this obligation has been interpreted as a need to maintain a status quo rather than introducing potentially risky disruptions into the process.
Given this orientation around site-based data gathering, high-procedural variability, and responsibility to human participants, most trials have found themselves still relying on manual processes rather than digital ones. This, of course, has many drawbacks, such as:
- Potential for error. Whenever processes rely on manual checkpoints, rather than digital ones, you introduce the potential for human error, which could lead to protocol deviations.
- Endemic inefficiencies. One recent landscape study noted that (emphasis added) “inefficient encounter-driven system[s] that relied on manual intervention … could pose institutional risk at all stages.”
- Wasted or duplicated work. Clinical measurements, for example, are typically written by hand, re-entered into one or more systems, and then reviewed by a third-party monitor to ensure accuracy between handwritten and electronic data.
- Additional burdens placed on patients. In most trials, participants are required to come on-site frequently, and they may also be subject to invasive in-person questionnaires and other forms of data gathering (this takes on additional challenges in the age of social distancing).
While the potential benefits of digital technologies are well known, the industry has remained reluctant to challenge the operational status quo. But then a pandemic happened and proactively evolving trial procedures suddenly became an imperative.
In the face of a quick-moving, high-impact global health crisis, the entire healthcare industry—including the life sciences—has been compelled to go from tip-toeing forward on transformation into a full-on digital sprint.
"Digital processes are inherently more efficient, accurate, and transparent than "analog" ones, but the complexity and cost and risk of digitizing trial management processes have outweighed the potential benefits."
Up until a few months ago, for example, there was hesitancy on the part of many providers and patients to connect remotely via video conferencing, but social distancing rules forced them to change their habits. Video telehealth visits surged 50% in March alone, and are now on pace to hit 1 billion by year’s end. In the face of this new reality, regulatory bodies have responded accordingly and with uncharacteristic haste.
In the context of clinical trials, social distancing measures are disrupting the manual checkpoints and IRL processes that many trials are built around. The FDA has updated its rules regarding digital technologies in clinical settings to accommodate the new reality. Still, even with loosened regulations, the problems of variability and complexity remain—and this is where no-code can make a difference.
No-Code’s Place in Clinical Trial Transformation
Digital processes are inherently more efficient, accurate, and transparent than "analog" ones, but the complexity, cost, and risk of digitizing trial management processes have outweighed the potential benefits. (At least, this was the case when relying on code.)
Building a bespoke management solution from the ground-up for each new trial would be infeasible using traditional development methodologies. It would take too long and be too expensive, and the resulting software would not have a life beyond the trial.
Check out this demo of Unqork's Secure Document Exchange Solution, which supports comprehensive Source Document Verification.
Some off-the-shelf, area-specific technologies may inject some efficiencies and automation to a specific part of a trial, e.g., Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Electronic Patient-Reported Outcomes (ePRO), but they aren’t able to overcome the challenges of transformation by themselves because:
- It’s difficult to securely integrate prebuilt, area-specific solutions into a legacy tech stack. Trial processes need to function with disparate legacy systems, which isn’t always easy. They require multiple users with strict controls around who can access what data, and the transfer of sensitive information across parties.
- Code is often still needed to configure off-the-shelf software anyway, which defeats the point. Trial solutions require tailored document management, complex logic and decisions triggered by actions and/or changes in data, and high-fidelity user interfaces for patients, physicians, and doctors. Many software vendors can handle some or all of these requirements, but for organizations creating their modules or solutions with code, it’s challenging to build these capabilities for disease- or therapy-specific requirements across hundreds of trials, often with very short time windows from trial design to First Patient In (FPI).
This is where no-code can make a profound difference.
No-code is a category of cloud-computing services that eliminates the need to compromise on speed, security, functionality, or flexibility.
Enterprise-grade no-code platforms like Unqork aren’t just some new development tool, they are complete development paradigm which comes out-of-the-box with all the elements needed to build and maintain enterprise software. And, as the name implies, it completely removes the need to write any code, so organizations can focus all their resources on the needs of the trial rather than the needs of the technology.
Designing trial workflows with no-code bypasses many of the usual challenges of traditional software development and provides:
- Increased speed and flexibility: No-code platforms automate many high-volume coding tasks, which allows developers to focus on process logic and UX rather than syntax and codebases. Overall, this greatly accelerates the development process.
- Enhanced collaboration: Programmers are still central to the no-code development process, but it also opens access to a wide range of internal stakeholders. With a little bit of training, non-technical personnel (legal, accounting, research teams, etc) can directly apply their knowledge to relevant areas of the trial process, instead of relying on IT as an intermediary.
- Advanced data functionality: Advanced systems like Unqork can ingest and integrate data (both physical or electronic), which is invaluable in clinical trial operations. With this integration layer in place, everything associated with tailoring the trial process to specific cases becomes easier and faster. Designers can easily load datasets directly into the platform to pull into data transformations or custom calculations.
- Seamless integration: Companies won’t necessarily use no-code to create a new telemedicine platform, for example, but they will use them to integrate legacy and external technologies into systems and processes already in place including existing CTMSs or Clinical Research Information Systems (CRISs) they’ve used previously.
Want to learn more? Check out our recent webinar lead by Unqork healthcare lead Kara Dennis or head over to our Healthcare solutions page to learn more about how Unqork is changing the way the industry engages with technology.