Decentralized clinical trials (DCTs) offer great potential to rethink and refresh traditional models, enabling patients to interact with clinical researchers at home rather than in a clinical setting. When DCTs are indicated, this approach can greatly improve the patient-centricity of trials. Patients can receive direct drug shipments where everything required is delivered at home, for example, and rely on wearables for monitoring of vital signs. The patient visits the site only for necessary tests or treatment – such as an MRI scan or when a healthcare professional must administer an exact dosage at a specific time. Use of telemedicine retains the human touch while reducing the burden of trial participation on patients and clinicians themselves. And DCTs can increase access to a more diverse population.
To determine whether this approach is right for your protocol design, Allucent helps you determine the cost-benefit ratio and consider practicalities relevant to data quality, data integration, patient privacy, and of course safety. When DCTs can be incorporated cost-effectively, we will help you with flawless execution.
Allucent has extensive experience in DCTs, both fully virtual and hybrid approaches. We take advantage of the THREAD DCT trial platform, an all-in-one solution that enables our clients to offer an experience unique to each study stakeholder. The platform delivers efficiency, flexibility, and scalability, essential for managing remote, hybrid, and fully decentralized trials. The THREAD platform supports the following:
eConsent. Compliant, efficient eConsent can significantly reduce your site burden and offer convenience to patients. Participant consent can be managed securely, including both single and dual signatures, on any device.
eCOA. Electronic clinical outcome assessment (eCOA) is key to DCTs, but compliance and data quality are vital. With a unified, secure, continual data flow from multiple sources, compliance and protection of study data are assured.
Analytics. Real-time data on study performance, as well as predictive insights on study completion, enrollment, and retention, are delivered via a dashboard, helping drive decision making and optimizing outcomes.
Site data capture. Site data capture on-site, remotely, or during telehealth virtual visits is streamlined thanks to state-of-the-art technology.
Sensors. Simplicity in using wearables, medical devices, and health apps delivers a trial experience for participants that increases their engagement in the DCT. Study and platform administrators can add preconnected provisioned and bring-your-own devices (BYOD).