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COVID-19 forces sponsors to take new approach for assessing trial support models.
The disruption that clinical trials experienced during the COVID-19 pandemic has amplified the need for adaptive clinical trial platforms. Long-established platforms, many of which were designed decades ago for site-based studies, lack the capability to support increasingly decentralized and digitized trials.
When assessing whether a digital platform is optimized to support decentralized trials, sponsors should look for these four pillars: patient centricity, tailored interfaces, broad integrability, and preemptive compliance. This article will provide a general overview of what sponsors should identify when assessing integrated digital platforms and highlight a few key design elements that have contributed to the success of existing platforms or are likely to be essential in the future.
The primary appeal of decentralized trials is their inherent patient centricity, because they are able to bring the site to the patient and widen the population of target participants. While it’s important that integrated platforms can facilitate the logistics of a decentralized trial, the mark of true patient centricity in an integrated digital platform hinges on how well it can take into account patient needs, and translate those needs into study experience and its related design. To start with, a digital platform should make it easy for participants to screen, consent, and enroll themselves from home. The experience must be seamless from a tablet, web, or mobile interface. Integrated aids such as explanatory videos and instructional tutorials should guide participants through the process and help them understand the value of the study and their role in it. Paired with targeted patient outreach through social media, digital platforms can make enrollment more efficient and demographically representative.
An integrated digital platform optimized for decentralized trials should support and empower patients via a bring your own device (BYOD) model, and be architected with the most modern (web and mobile) responsive design to account for the number of external devices from which patients may access the trial.Enabling BYOD can simplify patient engagement because it (1) allows patients to use a device they are already familiar with, (2) reduces the number of devices they need to keep track of, and (3) helps ensure the security of private data. However, regardless of the specific capabilities of and access points to a platform, it must be easy to navigate and undemanding of a patient's time and resources. When selecting a platform, sponsors should also consider how well it is reinforced by related patient services, like device provisioning and ready access to representatives who can answer questions and troubleshoot issues.
An integrated clinical trial platform should not only be intuitive for the patient; it must be simultaneously tailored for the many other stakeholders in a clinical trial, such as site-personnel, remote/home-based nurses, caretakers, monitors, data managers and analysts. Having all such personas interfacing with a single integrated platform protects data integrity, facilitates uniform interaction within the confines of the protocol, and ensures efficiency in trial operations. Meanwhile, it is essential that the many individuals interacting with a single platform have intuitive access to the features and capabilities that are relevant to their roles.
Platforms that appropriately address this challenge will have invested extensive design efforts upfront so that the user experience is configurable to differing personas, and adaptive to rapid development of future roles or feature-sets. A scalable integrated platform must demonstrate composable architecture through an “Application Programming Interface (API) first” design. This allows for efficient development of future features and integrations while minimizing the impact to previously validated componentry and in-flight trial services. Along with personalized interfaces, well-optimized digital platforms may have role-specific guided app usage, and access to role-specialized human support services for troubleshooting.
Even as the interfaces with a clinical trial platform are tailored and intuitive, the underlying platform must be broadly compatible and easy to integrate with a site or sponsor’s system. One mark of system-to-system integrability is adoption of existing data integration standards such as Fast Healthcare Interoperability Resources (FHIR), a Health Level Seven International® (HL7®) standard for exchanging healthcare information electronically. FHIR has been proven at scale through utilization in healthcare, yet clinical trial systems continue to lag behind. An expression of confidence spoken among leading platforms and integrators is “FHIR in, FHIR out”.
A likely reason for the slow adoption of FHIR in clinical trials systems is the historical non-conformity of data collection requirements in research. Yet with this increasingly flexible and extensible standard, and the prevalence of off-the-shelf cloud provider services for FHIR integrations and storage, many of these foundational aspects of healthcare integration have already been established in a broad and standardized manner. Tapping into these resources can jumpstart integrated platform development, and provide a common framework upon which more site and sponsor systems can be integrated for more expedient data-based services. While many cloud-service integration partners are available, platforms that prioritize a single, strong partnership may offer uniformity and deep expertise that differentiates them from systems that maintain multiple cloud-partnerships.
When accessing integrated digital platforms for clinical trials, the historical benchmark of Good Clinical Practices, and validation of computerized systems (21 CFR Part 11) is a given. However, opting for a platform with bare-minimum compliance is short-sighted. Instead, compliance should be thought of as a feature-set, and platforms should have a detailed roadmap and implementation strategy for global compliance. This is especially important in preparation for the regulatory changes that are bound to accompany increasing digitization and remote verification of clinical data.
The most successful and robust digital platforms will maintain a compliance framework that demonstrates understanding of and appropriate alignment with existing compliance regulations. One well-established global framework is the General Data Protection Regulation (for the EU), but additional privacy frameworks include the Health Insurance Portability and Accountability Act (HIPAA) and California Consumer Privacy Act (CCPA).
The benefits of identifying a platform that maintains preemptive compliance are twofold: 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 drive a car with all-weather tires than to change the tires during a snow-storm. In the event of regulatory and service-line changes that account and allow for the increasing digitization and remote verification of health data, platforms with preemptive compliance require far less transition time and help alleviate costs.
It is well past time to demand digital platforms and associated services that can contribute to more adaptable, accessible, and efficient clinical trials. When assessing integrated digital platforms for their trials, sponsors should consider how well the platforms address the pillars of patient centricity, tailored interfaces, broad integrability and preemptive compliance. The right platforms will bolster the success of decentralized and digitized trials well into the future.
Matt Harrington, VP of Connected Health Technology Solutions, ICON