Decentralised clinical trials (DCTs) have revolutionised the way we conduct research, bringing convenience and accessibility to patients while enhancing the efficiency of data collection. DCTs offer several advantages over traditional, site-based approaches and have proven to improve patient engagement, retention and accelerate enrolment.
However, with every stride forward there is a need to refer back to the regulatory framework that is in place that ensures patient safety and maintains ethical standards.
There are challenges associated with DCTs that need to be considered when designing and conducting these studies. As DCTs become more prevalent, clear guidelines and oversight mechanisms are essential in ensuring that they are conducted safely and effectively.
This blog examines the crucial topic of regulating the use of DCTs, exploring what’s in place now and what sponsors need to consider as these methods continue to gain traction.
Current regulatory guidance
The regulatory landscape for DCTs is still emerging and evolving. This can make it difficult to know which laws and regulations apply, and how to comply with them. Additionally, because DCTs can be conducted almost anywhere using mobile technologies and the internet, there can be jurisdictional issues that complicate compliance. For example, if a trial is being conducted in multiple countries, each with its own laws and regulations, it can be difficult to ensure that all applicable laws and regulations are being followed. DCTs often involve new and innovative technology platforms and methods, all which need to be reviewed in terms of compliance.
The EMA has published a guidance (EMA/INS/GCP/112288/2023), and there is a Q&A document on qualifying novel methodologies (EMA, 2020) that are relevant to decentralised clinical trial approaches. The Q&A outlines a pre-approval procedure for the use of a variety of digital tools via an EMA/Committee for Medicinal Products for Human Use (CHMP) qualification opinion. This is similar to the scientific advice procedure in the EU and the Innovative Science and Technology Approaches for New Drugs (STAND) program managed by the FDA. Since gaining pre-approval is a protracted process, sponsors should fully understand what is entailed before proceeding.
The US Food and Drug Administration (FDA) published draft guidance on the use of digital health technology in traditional and decentralised trials in May 2023 and is required to provide the final guidance no later than 29 December 2023. It has also created the Digital Health Center of Excellence (within the Center for Devices and Radiologic Health) to support the use of digital health technologies in product approvals as well as to maintain an inventory of related guidance.
Considerations for privacy and data management
If used in clinical trials, digital health technologies require additional safeguards to protect information from corruption, compromise, or loss due to the private and sensitive nature of the information. Across the globe, countries have enacted comprehensive data protection laws specifying how personal data can be collected, transmitted, and processed, and new privacy laws continue to be introduced as technology advances.
Informed consent is a critical part of any clinical trial and potential participants must be fully informed about all aspects of the trial before they can give their consent. Participants must also be made aware of how their data will be used and have the opportunity to opt out of having their data used for research, at any time. DCTs offer new opportunities for conducting clinical trials, but they also raise new privacy and security concerns. Steps must be taken to ensure that trial data is properly secured, and that subjects’ privacy rights are respected.
Conclusion
In summary, the development of DCTs has brought forward a range of new possibilities for trial innovation but the regulatory and legal environment continues to evolve, and the responsibility is on sponsors to keep up to date. To do this they must firstly be aware of the layers of regulatory and legal frameworks in place currently. Secondly, they need to have their finger on the pulse of developments at a country, regional and global level with real time regulatory intelligence. Doing so will help ensure that advancements and benefits of DCTs continue without compromising patient safety and regulatory compliance.
Read our whitepaper to find out more about the current regulatory landscape, applicable data privacy laws related to technologies, and gain some practical advice on how to keep on top of developments.