Tech Is Imperative For Ongoing Engagement and Adherence
With the absence of regular in-person check-ins, maintaining participant engagement with a DCT can be challenging. Although digital platforms can be used in traditional trials to deliver information such as a study’s objectives, procedures, and safeguards; patient rights; and trial outcomes, technology plays a much larger role in DCTs. Social media campaigns, virtual webinars, interactive apps, and email newsletters are effective tools to maintain ongoing communication, share study updates, and address patient queries. Gamified elements (e.g., make participation in a trial a game-like challenge), milestone rewards, and regular feedback loops can encourage continuous participation. SMS reminders, interactive challenges, and virtual peer communities can further enhance adherence to study protocols.
But digital doesn't mean impersonal. Virtual helpdesks, teleconsultations, and chatbots can offer real-time assistance, ensuring participants have a support system whenever they encounter challenges.
The following are some of the fundamental technologies that form the backbone of DCTs.
- Mobile Health Devices and Wearable Technology: Modern DCTs heavily rely on wearables and mobile health devices to collect patient data remotely. From smartwatches that monitor heart rate and sleep patterns to specialized devices that track specific health metrics, these gadgets enable continuous data collection without participant discomfort.
- Telemedicine Platforms: Essential for remote patient consultations, telemedicine platforms facilitate virtual interactions between researchers and participants. This digital bridge not only keeps the communication channels open but also allows for timely interventions, ensuring patient safety and study adherence.
- Digital Patient-Engagement Tools: Digital engagement tools, like mobile apps and interactive platforms, send reminders, share educational content, and provide a medium for participants to report symptoms or ask questions, fostering a sense of involvement and trust.
- Data Storage and Security Protocols: With the massive amounts of digital data generated, DCTs necessitate robust storage solutions. Cloud storage, integrated with strong encryption and cybersecurity measures, ensures data integrity and confidentiality, addressing potential concerns related to data breaches or misuse.
- eConsent Solutions: The digital realm of DCTs requires a reimagined approach to informed consent. eConsent platforms facilitate the remote delivery, comprehension, and acknowledgment of study information. These platforms, often interactive, prioritize clarity and ensure participants are fully aware of study implications.
According to ISR Reports’ 2022 “Decentralized Clinical Trials Outlook”, some other common decentralized components include:
- Direct-to-patient shipment of investigational medicinal product (IMP)
- Home nurse visits
- Local/Community Labs