Author: Henk Dieteren, Clinical Supply Chain Solutions Consultant
Snapshot:
- Trial models differ: FDA permits fully decentralized trials while EMA requires hybrid models with site visit options
- Regulatory expectations vary: Key agencies define DCTs differently, creating distinct requirements for global trials
- Consent processes contrast: Face-to-face requirements in Europe versus electronic options in the US demand different planning
Clinical trials are increasingly becoming more patient-centric, efficient, and accessible. Decentralized clinical trials (DCTs) address these needs by giving patients greater flexibility in how to participate in a trial.
In September 2024, the U.S. Food and Drug Administration (FDA), released its guidance “Conducting Clinical Trials with Decentralized Elements,” offering recommendations for implementing DCTs.
The EU Medicines Agency (EMA), which serves a similar function across the European Union member states, previously released its own guidance as well. As a result, there are currently at least two guidance documents that clinical trial sponsors must navigate when running trials in the US and EU regions. 1,2
This blog is the first in a series of three that compares the FDA and EMA approaches to help sponsors design trials with decentralized elements that meet requirements in both regions.
How regulators define decentralized trials
The FDA defines DCTs as “clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites.” The EMA takes a different angle, describing the DCT approach as one that “seeks to take advantage of technological progress and introduce new methodologies to make clinical trials more easily accessible and participation more convenient for trial participants.”
While both agencies acknowledge the concept of decentralized trials, their fundamental approaches differ significantly:
FDA approach: The FDA permits fully decentralized trials for certain investigational products (IPs) including drugs, biological products, and devices (referred to as “products” from here). This approach works best for IPs with well-characterized safety profiles that don't require complex preparation, administration, or medical assessments. However, the FDA's recommendations remain nonbinding unless they cite specific regulatory requirements.
EMA approach: EMA has created DCT guidance based on current context and trends, highlighting the need for further recommendations on introducing decentralized elements in EU/EEA clinical trials, regardless of health crises and considering limited national guidance. The intention is to facilitate decentralized elements in EU/EEA clinical trials while providing necessary levels of trial participant safety, protection of their rights and dignity. More importantly, under EMA guidelines, sponsors and investigators retain the same accountability whether activities occur at physical sites or remotely.
FDA vs EMA: Key differences at-a-glance
* Investigational products include drugs, biologicals, medical devices, and other experimental products being tested in clinical trials
The differences in the model create practical implications for trial designs across the US and EU regions, especially when sponsors must account for both regulatory frameworks.
Informed consent requirements
The patient consent process is an example of the contrast between FDA and EMA approaches to DCTs.
FDA position: The FDA guidance allows remote informed consent to be obtained electronically, provided all regulatory requirements are met. Investigators can obtain electronic informed consent remotely from trial participants, with the option to include a remote visit if needed.
EMA position: The EMA takes a less uniform approach to informed consent, given the differences between the member states. Their guidance emphasizes the benefits of face-to-face communication between potential participants and investigators or qualified personnel.
If this discussion occurs digitally, the EMA recommends real-time interaction where parties can both see and communicate with each other via audio and video. They require a detailed documentation of the consent process in the clinical trial application, including a general overview of the workflow showing which DCT-associated tasks and actions are conducted, with full details provided in protocol-related documents.
The EMA also specifies that all consent processes, whether fully or partially remote, must comply with other regulations like ICH E6, GDPR, and national legislation. Sponsors must describe the entire procedure step-by-step in their clinical trial application to allow for thorough ethical review.
Suvoda eConsent support: Suvoda eConsent addresses both regulatory frameworks by offering flexibility for EU member state requirements. While all EU member states allow digital consent procedures, some don't permit electronic signatures. For those cases, wet-ink uploaded PDFs are treated similarly to digitally signed consent, providing compliance across different regulatory environments.
How these differences affect protocol development
When sponsors design DCTs across the US and EU regions, protocol decisions from site selection should account for both frameworks. Both FDA and EMA allow for fully decentralized trials as well as hybrid models, but they require sponsors to assess and describe the risks of their chosen approach, including clear justification for why the selected model is appropriate under the specific trial circumstances.
Understanding these differences early can prevent costly redesigns, delays, and unacceptable patient risks. As digitalization becomes more common, and the focus on patient centricity increases, sponsors who can manage these regulatory differences have the opportunity to design and implement more efficient, global trials.
Understanding the global regulatory environment is essential for validated solutions like IRT, eCOA, and eConsent. That's why at Suvoda, we closely monitor regulatory requirements so that every solution we offer can support the evolving needs of global trials and complex protocols.
Suvoda works to provide data integrity and quality in the most accurate and efficient way, giving sponsors, sites, and patients peace of mind when setting up and participating in clinical trials.
Author
Henk Dieteren
Clinical Supply Chain Solutions Consultant
References:
- U.S. Department of Health and Human Services, Food and Drug Administration. "Conducting Clinical Trials with Decentralized Elements: Guidance for Industry, Investigators, and Other Interested Parties." Silver Spring, MD: Food and Drug Administration, September 2024.
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European Medicines Agency. "Recommendation Paper on Decentralised Elements in Clinical Trials." Version 01, December 13, 2022.