The regulatory landscape for decentralized trials differs from that of centralized or traditional trials, creating ambiguity in roles and responsibilities among physicians, investigators, sponsors, and other stakeholders. Unlike centralized trials where the sponsor sets specific study procedures and rules, governing rules and study procedures in DCTs can vary. 

While DCTs have historically adhered to the same regulations and standards as centralized trials, such as good clinical practices (GCPs)—a set of guidelines for conducting ethical and scientifically rigorous clinical research—the recent surge in DCTs has made it clear that their regulatory environment is unique and must be carefully evaluated. Across counties, the following regulations and guidelines are in effect: 

• United States: The FDA actively supports innovative trial designs, including decentralized trials. In June, the agency issued updated recommendations for GCPs to modernize clinical trial design and conduct, aiming to improve efficiency and reduce administrative burdens. These recommendations also promote the use of fit-for-purpose innovative digital health technologies (DHTs), such as wearable sensors.   

The FDA recently issued other documents that complement these efforts. In May, they published draft guidance proposing recommendations for implementing DCTs. Additionally, the agency recently released a framework document for DHTs, providing guidance on utilizing DHT-derived data in regulatory decision-making for drugs and biological products. 

• Canada: Through several regulatory proposals and a clinical trial regulatory modernization initiative, Health Canada, responsible for national health policy, has promoted and enabled DCTs. These efforts aim to make DCTs more practical for sponsors and incorporate them as an important component of modernizing clinical trials regulation in Canada. 

• United Kingdom: The Medicines and Healthcare Products Regulatory Agency, responsible for clinical trial oversight in the United Kingdom, has taken significant steps to address the impact of the pandemic on clinical trials. They released guidance on managing clinical trials during the pandemic and minimizing disruptions to their conduct and integrity. 

Additionally, the passage of the Medicines and Medical Devices Act in 2021 highlights the regulatory focus on clinical trials. The guidelines and regulations advocate for a decentralized approach to clinical trials and emphasize the utilization of digital health technologies as part of modernizing trial practices. 

• European Union: In response to the pandemic, the European Commission issued updated guidance on the management of clinical trials. Furthermore, the European Union's Clinical Trials Regulation came into effect in early 2022. The guidelines and regulations specifically address various aspects of decentralized clinical trials, including electronic medical records, remote monitoring, and remote data source verification. However, the regulation of decentralized clinical trial components varies considerably among EU member states. 

• Australia: Australia has been actively exploring the use of DCTs and digital health technologies in clinical research. In 2020, the country released its National Principles for Teletrials as part of a comprehensive Teletrials Compendium. The compendium, also comprising the National Standard Operating Procedures for Clinical Trials, aims to establish a consistent approach to implementing teletrials across Australia.  

• Asia Pacific: The Asia Pacific region is viewed as a promising frontier for DCTs. In 2021, Singapore's Health Sciences Authority issued guidance on the conduct of clinical trials and the use of electronic consent. In August 2022, China's Center for Drug Evaluation published draft guidelines on patient-centric clinical trials, covering topics such as decentralized trials, patient experience data, and clinical outcome assessment. These guidelines provide comprehensive guidance on trial design, implementation, and benefit-risk evaluation. Nevertheless, the Asia Pacific region still presents a diverse range of regulations and requirements for clinical development. 

Opportunities, Challenges, and Technological Advancements in DCT Regulation 

As DCTs’ popularity increases, new regulatory frameworks and approaches to their management are likely to emerge. In this section, we will examine DCT regulation's future, including potential opportunities and challenges for DCT solution providers. 

• Increased regulatory support of DCTs: Regulatory agencies worldwide have recognized DCTs' benefits and implemented initiatives to promote their use. One notable example is the Danish Medicines Agency, which has taken a proactive approach to establish a comprehensive and modern regulatory framework for DCTs. Similarly, the Swedish Medical Products Agency is committed to providing ongoing regulatory guidance on decentralized elements within clinical trials. 

• Regulatory complexity due to regional differences: The regulatory environment for DCTs varies greatly between countries and changes constantly. The variability of regulatory frameworks has introduced complexity in navigating and staying up-to-date with them. In the absence of consistent standards, sponsors, contract research organizations (CROs), DCT providers, and vendors are likely to have to prioritize markets with lower regulatory barriers. 

• Technology advances drive new initiatives: Digital health and mobile technologies will drive future regulatory developments in DCTs. As technology rapidly evolves in this area, regulatory agencies globally will need to adapt accordingly. This could entail numerous changes and create a complex regulatory environment. Countries will likely introduce more regulations clarifying access to health technologies and technical requirements. 

• Higher demand for data privacy and security: As the collection and exchange of participants' personal information in clinical trials increase, data protection emerges as a critical priority and a significant policy concern. Sponsors and CROs bear the responsibility of complying with data privacy laws and providing evidence, documents, and audit trails to demonstrate their compliance. 

Developing a Forward-Looking Strategy for DCT Compliance 

With the global shift toward remote clinical trials, compliance has become increasingly important for sponsors and providers. The complex regulatory landscape across multiple countries makes effective navigation imperative. Sponsors, vendors, and DCT providers should prioritize understanding country-specific regulations, seeking guidance from regulatory experts, and assessing their impact on DCT implementation.