Considerations in choosing the right decentralised clinical trial platform

Patients at the centre of technology decisions

Being able to make it easier for patients to participate and stay engaged in a clinical trial has never been more important. Noting the benefits of increased patient recruitment metrics and access to diverse and under-served populations, the appeal of decentralised clinical trials remains their inherent patient centricity. While it is important that such platforms can facilitate the logistics and integration of data from a decentralised clinical trial, their true success lies in the ability to make the trial truly accessible for the patient.

When assessing decentralised clinical trial platforms for a trial / portfolio, sponsors need to consider how well the platforms address the pillars of patient centricity, broad integrability and pre-emptive compliance. The platform should be developed in a way that enables the integration of a variety of patient services depending on the characteristics of the study while remaining capable of successfully delivering a positive clinical trial experience for the patient.

To start, a platform must make it easy for patients to remotely screen, consent, and enroll in a trial. The experience must be seamless from a tablet, web, or mobile interface. If applicable to the study, a decentralised clinical trial platform should also be able to support and empower patients with an array of connected devices that can easily capture, integrate, and aggregate health data with other traditional datapoint capture. Additionally, a Bring Your Own Device (BYOD) model can simplify engagement as it allows patients to use a familiar device and limits the burden of additional hardware while aligning to one’s own data privacy and security preferences. Regardless of the specific capabilities of and access points to a platform, it must be easy to navigate and ideally trigger notification of upcoming tasks being mindful of the patient’s time and resources.

When assessing integrated decentralised clinical trial platforms, the historical benchmark of Good Clinical Practices, and validation of computerised systems (21 CFR Part 11) is a given. The benefits of identifying a platform that maintains pre-emptive compliance are two-fold. First, it is compelling to participants and regulators, and may lead to expedited regulatory reviews, validation activities and greater public confidence. Second, a compliant architectural framework is significantly easier to implement proactively than retrospectively. It is better to be prepared for all eventualities rather than having to change course or adapt mid trial subsequently impacting on study timelines. In the event of regulatory and service line changes that account and allow for the increasing digitisation and remote verification of health data, platforms with pre-emptive compliance require far less transition time and help alleviate costs.

It goes without saying that exploring the capability of the technology is crucial, however choosing the right partner to deliver a decentralised clinical trial platform and its related study services, is equally important. A partner that can provide insight on digital health technology strategies, from the choice of device to kitting and logistics, enabling validated eCOA libraries and translations without causing delays in set-up; keeping on top of regulatory developments and most importantly providing the support services to help the patient navigate the trial will ensure timely success and improved results.

Author: Matthew Harrington , Vice President, IT, Applied digital solutions

Matt drives the app development connecting patients with clinical trials at ICON plc

ICON Digital Platform: Seamless integration and delivery of patient focused services and innovation