In Part 1 of this series on Reducing Risk in Decentralized Trials, we covered 7 key issues that Sponsors need to consider when designing a #DCT. In this installment, let's talk about how best to mitigate and even eliminate that risk through Digital Automation...and practice.
Let’s first define Digital Automation. In a nutshell it means you as the Sponsor have unlimited capability to connect a chain wide variety of tightly or loosely integrated workflows and interdependencies to ensure your research protocol is conducted without errors and guesswork. Remember, a DCT means more people are involved while not being colocated. As such the UX needs to be tightly orchestrated between and amongst people who are not in earshot of each other. Disparate staff can’t rely on real-time verbal/nonverbal communication or brick and mortar business processes. When these ways of collaborating and communicating are gone, designing a trial “on paper” and then handing it off to a service provider will have little chance of succeeding.
Automation of clinical trials means you can tightly orchestrate and practice the real workflow and graphical user interface that each person in the study will need to faithfully execute their activities, whether it be a blood draw, ePRO, or a physical exam – some might also call this a Digital Trial. Clinical trial automation also relieves pain points you only thought you had to live with. Imagine being able to:
- Design and practice subsections of the study UX/UI and get them right in an agile method
- Work more closely with patients and study staff during design to optimize their experience beyond reading words and bullet points, using the real UI
- Pressure test key 3rd party tech and personnel collaborations well before going live
- Design alternatives so you are ready for any potential, testable failure modes, as well as regulatory/executive management decisions that may affect the study design
- Having all your automations in a library for future use, increasing your efficiency exponentially
For clinic staff, a digital clinical trials can offer simple delighters like providing access to key 3rd party portals at the exact time they are needed. Or ensuring that if Vital Signs need to be captured at least 15 minutes after another procedure, that there won't ever be an error. Ultimately, the use of digital trials means not having to remember to look something up in a protocol or document because the workflow is laid out in front them, increasing efficiency, reducing wait times, and delivering high quality data.
Conversely, relying on traditional service providers that might frame technology solely for data capture means that many behaviors and decisions required by patients and study staff are left to chance, and likely executed with a high degree of variability or error rate. In a decentralized model, this risk is exponential in its frequency and magnitude given the disparate nature of the workflow and individuals.
If you are going to go there, there is a better way to get DCTs right. Because the most important elements of study conduct aren’t always about data capture per se - it's the tacit behaviors, preparation, communication, coordination, access to tech, wait times, logistics triggers and other activities not explicitly laid out in the research protocol. So don’t leave anything to guesswork. Automate the heck out of it, and then practice it too.