When working with researchers and clinicians to design trials that include digital elements, it’s important to speak the same language. Just as clinical lingo must be precise so that everyone understands its meaning, adding digital elements to a clinical trial can spur confusion if people are not on the same page. We thought it would be helpful to outline some of the commonly misunderstood digital health jargon so that those planning to incorporate digital elements can start off on the right foot.
Real-World Data (RWD) / Real-World Evidence (RWE) vs Traditional Clinical Trial Data/Evidence
In order for a drug or intervention to progress within the FDA’s research framework, it must submit evidence supporting the potential benefits and risks derived from data. This includes “pre-market” analysis conducted before a product is approved and released and “post-market” surveillance that involves the ongoing monitoring and evaluation for safety after release.
In traditional clinical trials, data is collected in a controlled clinical environment and is often referred to as traditional clinical trial data. The collection of this data typically involves a patient traveling to a clinic for monitoring by a trained medical professional.
The use of mobile devices, wearable biometric devices, and computers has enabled a relatively new and important source of information. Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions and research. Simply put, RWD are data relating to a patient’s health collected from a variety of sources such as mobile devices, biometric devices, and EHR records. RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from the analysis of RWD. For more detailed information see the FDA’s Framework for FDA’s Real-World Evidence Program.
Real-world evidence (RWE) and traditional clinical trial data are considered complementary. Collectively they provide a more comprehensive view of a patient’s health. Traditional data will always be viewed as the most reliable source of information and the most valuable data for pre-market submission. RWE on the other hand allows researchers to monitor a patient’s health outside of in-person visits and it allows researchers to consider additional factors and variables. RWE can be used in pre-market research but is particularly valuable for post-market surveillance.
Decentralized/Virtual Trials vs Hybrid Trials vs Traditional Trials
Trial design is one of the first elements researchers consider when envisioning their studies. Traditional trials, where patients come to the study site for all evaluations and screenings, were the norm prior to the COVID-19 pandemic, though there was already a shift to using more virtual models. The shut-downs encouraged investigators to adapt in order to begin or continue their studies.
According to one report, the pandemic accelerated the shift to the next year or two, with more investigators running hybrid trials and decentralized trials. A hybrid trial uses both in-person and virtual data gathering. Perhaps the patient interacts with the study staff in the office for some evaluations while collecting data at home from wearables and sensors, mobile phones, telehealth visits, and/or electronic data entry.
Decentralized trials are also known as virtual, site-less, or remote trials. All the data from these studies are gathered at home. A patient may log into a platform or website to give feedback instead of recording it in journal form on paper, which is brought into the office. In a fully decentralized trial, the patient would not need to come to the study site at all. In both decentralized and hybrid trials, a patient may be able to get their blood tests done locally or through a home visit by a traveling phlebotomist. Medications can be sent to the home or to a local healthcare facility, rather than the patient traveling to the study site.
It’s important for trial sponsors to understand the benefits of each approach when designing the study. Traditional trials are best when the patient needs to be evaluated in person. In this case, neither telehealth visits nor digital devices would adequately provide the ideal data or information.
Hybrid and decentralized trials allow more patients to participate. It’s been shown that 70 percent of potential subjects live two or more hours from trial locations. With hybrid or fully remote trials, investigators can draw in participants from remote areas as well as subjects who live closer to a trial location, but may not have the time, ability or transportation to get to appointments. A hybrid or decentralized trial allows researchers access to a wider variety of participants, including those who normally do not participate. These trials are also considered more patient-centric as the trial comes to the patients, rather than the patients coming to the clinician. They can also increase the subject retention rate.
No-Code/Low-Code Platforms vs Custom App Development
When a researcher or healthcare system wants to develop a digital health app to use in a clinical study, designing one from scratch seems like the most obvious choice. That’s because each study is different and organizations want their own stamp on the data and user experience. A custom app can be built from scratch with all-new coding and functionality, but it must be HIPAA compliant. It should connect and integrate with sensors, wearables, and health data sources like electronic health record (EHR) systems, and with third-party technologies like Bluetooth, Google Fit, and Apple Health. A researcher might also want to use a developer with experience in Apple’s ResearchKit and CareKit frameworks. That’s a lot to ask for in a custom app, especially when the researcher is itching to start the trial. Designing a virtual care app from scratch is expensive and time consuming to plan, code, test, and roll out.
Investigators may not realize there are other high-quality options. A no-code or low-code platform offers a huge head start with all the necessary building blocks, integrations, & security features needed to develop a digital health app. Think about websites that can be built with drag-and-drop functionality. The user does not need a coding background to build a beautiful and functional website if the template allows them to drag in the widgets or functions they want, change the font and color, rename the tabs, add fields to collect data, and add art. This is a no-code system.
No-code platforms can offer a deeper level of customization by enabling some levels of custom coding, thereby becoming a low-code platform. The coding can be quickly done by a developer, taking much less time and money than building an app or platform from scratch.
Integration vs Interoperability vs Compatibility
These three categories have to do with software programs working together or in sync. An integrated system combines multiple applications so they can work in a unified manner, typically using some type of middleware as a translator. Integration is often an organization’s goal, as it allows the digital system to function holistically in one application, solving a user’s problem or problems.
Interoperability, on the other hand, is when multiple software programs or digital systems connect and exchange information with each other. It allows for access to unified data to help an organization’s users manage and use the data. With interoperability, two separate technology systems can interact in dissimilar environments, like a third-party scheduling technology and an EHR system. The systems communicate through a common language with no middleware required.
Compatibility is slightly different from interoperability. With compatibility, two software systems do not have to actually communicate with each other. They need to be able to work together without making changes to each other. An example is if you could open a Word document from Google Docs and vice versa.
Pattern Health Can Help
The terminology can be confusing, but the digital tools don’t have to be. Pattern Health offers a no-code / low-code digital health platform to help organizations run decentralized and hybrid clinical trials, gather data remotely, and deliver behavioral interventions. Contact us to learn how we can support your trial.
What Can We Demystify Next?
The world of digital health is broad and complex and full of potentially confusing jargon and technical terms. What can we break down in the future? Contact us