Contributed Commentary by Caroline Shleifer, Founder and CEO of RegASK
November 3, 2023 | The global decentralized clinical trials (DCTs) market is expected to see significant growth in the coming years. In 2021, the market was valued at $8.8 billion. And in 2026, the market is projected to reach $14.2 billion.
Several key factors are fueling this transformation, including the impact of COVID-19 lockdowns and restrictions, the increasing demand for faster and more cost-effective drug trials, the growing preference of patients to participate in clinical trials remotely, and the availability of electronic patient-reported outcomes (ePRO), and wearable devices and sensors that facilitate easier data collection.
With DCTs on the rise, regulatory bodies have taken notice. As a result, the U.S. Food and Drug Administration and international regulatory bodies have issued guidance and regulations addressing DCTs.
In May, the FDA released draft guidance for implementing DCTs, sparking a wave of excitement and anticipation within the field of clinical trials. The much-awaited guidance marks a significant milestone in the evolution of clinical trial methodologies, signaling clear support for the global shift toward expanded trial models. By releasing the guidance, the FDA reaffirms its commitment to promoting innovation in clinical trial design and emphasizes the need for careful consideration, training, oversight, and risk management for the successful implementation of DCTs.
Decentralized Approaches for Efficient and Patient-Centric Research
DCTs, also known as remote or virtual clinical trials, utilize telemedicine and mobile or local healthcare providers to implement procedures that differ from traditional clinical trials. They offer convenience by allowing aspects of the study to be conducted remotely, such as at home or in a local lab. Technology plays a vital role in DCTs, enabling components like eConsent, ePRO, telemedicine, wearable devices, home nursing, and remote patient monitoring.
For pharmaceutical and biotech companies, in-person trials are notoriously expensive and time-consuming, resulting in financial strain, lengthy development timelines, and high failure rates. However, DCTs have a number of benefits, including enhanced patient recruitment rates, cost reduction, and improved patient compliance and retention. They also provide patients with more flexibility by reducing travel and missed work or school.
DCTs offer the advantage of generating more realistic datasets. Patients can also participate in trials from their homes rather than from hospitals or clinics. As a result, researchers can collect more accurate data, which can then be applied to real-world situations. Embracing DCTs can lead to more affordable, efficient, and safer trials overall.
The Evolving Regulatory Landscape of Decentralized Trials
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.
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.
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.
Discussions with regulatory authorities are essential for building strong relationships, aligning DCTs with regulatory expectations, and facilitating productive interactions. In order to support regulatory compliance, working with a company equipped with a comprehensive intelligence platform and a network of local regulatory experts can be an invaluable resource.
Due to the interplay of multiple regulations and the high level of variability between countries, finding a regulatory company that provides automated monitoring of regulatory landscapes is crucial. Such a regulatory company can offer subscriptions to CROs and sponsors, enabling them to monitor regulatory landscapes, forge relationships with local experts, and access relevant information. Subscriptions can be helpful at all stages of a clinical trial, from planning to implementation.
Plus, companies offering compliance solutions provide CROs and sponsors with local experts who can assist with submission requirements. They can also monitor changes throughout the trial and prevent delays. These solutions ensure that all trials are conducted in accordance with applicable regulations and guidelines.
As DCTs gain momentum, organizations must not only prioritize compliance but also adapt to evolving guidelines. By fostering open communication, embracing innovation, and navigating the future of DCTs, organizations can drive patient-centric trial approaches and advance the field of clinical research. Seeking guidance from regulatory experts, understanding country-specific regulations, and leveraging regulatory partnerships will be crucial for success in this evolving landscape.
Caroline Shleifer is the founder of RegASK, a RegTech company using cutting-edge technology to address the challenges of the regulatory intelligence and compliance industry. Under her leadership, the company closed its Series A in December 2022, demonstrating the market’s confidence in the company’s vision and potential. Prior to founding RegASK, Caroline was one of the early partners at SPRIM, a global health consulting firm where she forged her entrepreneurship and lately headed the Regulatory & Scientific Affairs globally. Caroline holds a PharmD-PhD in Medical Physics from the University of Paris V, France, where she gained a deep understanding of the intersection of healthcare and technology. She can be reached at email@example.com.