John Reites

As the COVID-19 pandemic continues to challenge traditional ways of doing business, clinical trial sponsors and clinical research organizations (CROs) across the globe have adopted 

more sophisticated technologies and innovative study designs

 by incorporating a decentralized approach to address challenges in recruitment, retention, and data capturing. This industrywide shift to decentralized clinical trials (DCTs), whether fully virtual or hybrid, requires a global focus. This focus includes many considerations for sponsors and CROs such as global availability, global technology, and data integration.

Knowledge of global availability includes having insights by country that detail the availability of digital infrastructure, regulatory stance on technology features and actual regulatory approval of DCT approaches. A deep understanding of these insights is essential when deploying hybrid decentralized studies globally.

Digital infrastructure can be difficult to assess due to its complexity. The key factors to consider are internet availability (i.e., obtained from industry market research), data plan coverage (i.e., obtained from local wireless carriers), and bring your own device (BYOD) flexibility (i.e., confirming the percentage of provisioned devices required on average in a specific country). Regulations differ within regions and from country to country regarding which technology features (i.e., eConsent, telehealth) are approved for use. Especially during the pandemic, many of these rules have been relaxed to support more remote data capture and virtual visits. Anecdotally, eConsent is trending as more widely allowed globally during the pandemic as compared to pre-pandemic. Although the regulations surrounding eConsent have modernized over the past few years, the pandemic required electronic consent approaches to continue clinical trials—expanding its use in 2020.

The ability to map regulatory stances and actual global approvals by region, country and feature is an important process to manage when deploying decentralized studies at scale. The context of use (i.e., “telehealth captured the following assessments via a virtual visit”) is also becoming a key global availability insight that is learned from global experience. Capturing this information from design through study completion creates value for current and future DCTs.

When considering decentralized approaches for a clinical trial, it is important to focus on configuration (not custom development) of a global technology platform that can support your fit-for-purpose study use. Sponsors and CROs that take a measured approach and plan their scaling efforts before their studies are underway can lay the groundwork for smoother execution and avoid technological challenges.

When scaling global hybrid decentralized trials, there are many decisions made at the platform level. These decisions help to set standard setup parameters; confirm which features will be available for which countries; ensure the assessment library matches future study needs; and ensure consistent use of content, data collection, and features for global studies across customer portfolios. These decisions include but are not limited to which assessments will be used to support endpoint capture, how much choice will be provided to sites/participants in deciding which visits will be on-site versus telehealth, and what is the country roll-out plan in the initial studies.

Selecting specific therapeutic targets or study designs can also support the plan to scale DCT. Some assessments that provide the primary or secondary endpoint for specific condition may be available for collection via a telehealth virtual visit or home health visit but may not be desired to be collected outside of the clinic. Making these decisions in advance at an assessment and endpoint collection level will best support any sponsors’ plans to decentralized studies.

After decisions are made on the global technology platform, the next key step in scaling a DCT is the strategy for data integration. This plan should include setup of integrations for systems such as interactive response technology (IRT) and clinical trial management software (CTMS). Predetermining and ensuring integrations are in place with the specific systems impacted will make future study launches more efficient and quicker to launch.

Developing a common content library also has benefits in supporting a global scale plan. Any assets that will be used repeatedly in trials—such as ePROs, ClinROs, sensors (i.e., medical devices, wearables, etc.), branding or patient-facing copy, training videos, satisfaction surveys, or translated patient-facing content—should be built into a library and become automatically available for study teams as they scale and launch decentralized trials. This library approach enables consistency within a sponsor’s studies and across drug portfolios.

There are many critical considerations for sponsors and CROs looking to scale decentralized trial approaches, including how to conduct these efforts globally. Understanding digital infrastructure and regulatory landscape in target countries, carefully choosing a configurable technology platform, and developing a sound data integration strategy are foundational to successfully scaling a study. As the industry continues to shift from local to global research, sponsors and CROs must consider how they’ll remain competitive and productive in this new environment. Leveraging DCTs is one way to stay ahead of the curve.

Articles

The industry wide shift to decentralized clinical trials includes considerations for sponsors and CROs such as global availability, global technology, and data integration. 

John Reites

Articles

Harness Technology to Scale Global Hybrid Decentralized Studies