How to efficiently recruit the right patients for your next digital therapeutics (DTx) study
A common trend throughout the DTx industry is the growing need for real-world clinical evidence collection in settings mimicking that of the intended use case – implying that studies for digital therapeutics should be taking place at least partly in settings where patients would be using them most often. This is particularly important for sponsors seeking regulatory submission and approval. Additionally, the participants in a study need to be an accurate representation of the patients who will likely be prescribed that digital therapy in the real world.
The Digital Therapeutics Alliance (DTA)’s newest whitepaper, Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard, states “equitable participant selection is fundamental for enhancing the social value of DTx products and promoting their clinical effectiveness.” Furthermore, “insufficient participation from some groups within a population can result in inadequate information pertaining to the safety and effectiveness of the DTx product in important subpopulations.” In order to capture the proper data points within an applicable study setting among a representative patient population, appropriate patient recruitment strategies and execution are crucial.
Designing a recruitment strategy for success
When a DTx study is being designed, it is important that sponsors can build a recruitment strategy that is accurate, effective, and executable. To do this, particularly in a decentralized or virtual trial environment, sponsors can utilize the expertise of a DCT partner, like Curebase, with direct and relevant experience in DTx patient recruitment. A well-experienced partner can offer the insights, data, and historic success needed to build fit-for-purpose recruitment plans that are flexible enough to accommodate and adapt with a DTx trial. This type of DCT partner will also be properly equipped to fully execute that recruitment plan with state-of-the-art technology and services.
Reaching the right populations with the right site model
Identifying the desired patient population for a DTx trial is important, but reaching them and offering a trial that allows them to participate is an entirely different challenge. Because many DTx trials have virtual components, it makes it easier to incorporate remote care options to offer patients when possible. For example, if a particular DTx study does not require any in-person patient interactions, a virtual site model can be leveraged to recruit patients using a geographically broad direct-to-patient strategy that then allows patients to enroll, consent, and participate entirely from their homes. This model helps sponsors reach diverse patient populations while mitigating participation challenges like language barriers, geography, travel time, etc.
Full-service DCT partners can also offer other flexible site models that directly cater to the needs of individual DTx studies. With this, they can also include effective trial recruitment strategies based on a clinical site’s needs and capabilities. If a hybrid site model makes the most sense for effectively reaching specific patients to recruit in a DTx study, the right DCT partner can activate the desired site, train site staff, and provide the necessary technology to give sites the ability to enroll patients directly on site once upon walking in. This type of hybrid model recruitment can give sponsors access to patients that are likely to seek care at one of those activated sites, enroll them, and allow them to partake in the DTx study remotely for the remainder of their participation.
Having the right partner with fit-for-purpose, technology-driven services, and virtual capabilities enables sponsors to run their DTx studies in settings that allow for real-world clinical data collection while being able to recruit diverse and qualified patient populations.