Adoption of hybrid and virtual trials is increasing, resulting in the proliferation of technology solutions that enable trial virtualization. Technology is a key enabler of these trials, increasingly called Decentralized Clinical Trials (DCTs). However, successful implementation requires a seamless interplay of direct-to-patient services, new data management models, an optimized regulatory strategy and new processes that will ensure compliant delivery, reduce patient burden and increase patient engagement. Four activities are essential to implementing DCTs effectively: incorporating the voice of the patient, integrating technologies, selecting an optimal delivery strategy and using the right data.
Various tools and technologies are commonly deployed with the intent of reducing patient burden. However, the benefits of these technologies can only be realized when the patient perspective is fully incorporated into protocol design. Sponsors must deploy platforms and devices that are easy and comfortable to use, as well as streamline data capture and lessen the burden of participation to prevent overwhelming the patient. Deploying too many devices and digital interfaces may be counterproductive by increasing the patient responsibility and inconvenience, which may negatively impact compliance and data quality.
Voice of the patient (VoP) surveys can provide critical insights on how to deploy patient-centric technology solutions that maximize trial outcomes. VoP also allows sponsors to understand how patients want to participate and become informed on what convenience means to the patients.
Realizing the benefits of a DCT requires an integrated technology infrastructure that allows seamless connections between trial micro-services and clinical delivery data platforms/domains. When possible, a single centralized platform that serves as a hub is best. This approach allows all data to be centralized and patients or a study team to be notified of tasks or activities, ensuring that all study activity happens as expected. When disparate applications are deployed, it is critical to ensure that they are able to speak to each other via an application programming interface (API) that enables data transfer between the platforms.
Of course, selecting an optimal delivery strategy for DCTs requires more than just new technology and incremental changes to protocols. The entire study design and execution process needs to be reimagined, from study goals and objectives to each patient touchpoint with technology and digital tools, along with the study endpoints that will be collected and evaluated. The shift to a DCT model also necessitates the proper integration of medical and scientific requirements, while maintaining strict regulatory compliance in all regions where the trial is to be performed.
It is necessary to conduct a comprehensive assessment of multiple factors including study objectives and phase, patient population, disease burden and patient acuity (the level of care that a patient needs), primary and secondary endpoints, safety profile of the drug and delivery geography, among many other considerations. The outcome of this exercise helps determine the protocol suitability for a decentralized setting, the right technology and the optimal strategy for execution.
Data also plays an essential role in identifying eligible patients, accelerating recruitment and increasing retention. For example, the LabCorp Patient Direct program provides Covance with access to consented and interested patients along with the lab result values to enable direct-to-patient recruitment. In addition, the Covance Patient Intelligence Database, with more than 70,000 patients from 30 countries, enables surveying potential trial participants to obtain guidance in designing trials that reduce patient burden and, in turn, accelerate recruitment and increase retention.
Getting the most out of DCTs requires seamless interplay of technology, services, regulatory strategy, operational elements and clinical data that are all designed to best meet the needs of study participants. An optimal solution must manage the ecosystem of patient-centric services and include a framework to integrate rapidly evolving technologies into internal systems and processes in order to enhance patient experience, streamline execution and accelerate development timelines.
Depending on study design, the cost of DCTs may be higher than site-based studies. In such cases, the long-term benefits realized by reducing patient burden should be a key decision driver. As traditional studies increasingly face recruitment and enrollment challenges, expanding patient access and reach through decentralized delivery modalities can offer a paradigm shift for designing the trials around patients. The need for trial resiliency and continuity to be drivers of trial design is also increasingly important, driven by the challenges of the COVID-19 pandemic. These approaches are likely to boost return on investment by expediting recruitment timelines, increasing retention and engagement as well as improving data quality and patient compliance. Taken together, these elements can ultimately accelerate the speed of bringing new therapies to market.