Author: Henk Dieteren, Clinical Supply Chain Solutions Consultant
Snapshot:
- Investigational Product (IP) requirements: EMA provides detailed specifications for home delivery and storage while FDA links requirements to product characteristics
- Documentation standards vary: EMA highly recommends a data flow overview with additional explanations and ICH E6 compliance while FDA focuses on comprehensive management plans
- GDPR creates complexities: Trials in which an EU citizen is participating in are subject to additional data protection requirements that affect all aspects of DCT implementation
In my previous blog post, I explored the fundamental differences between FDA and EMA approaches to decentralized clinical trials (DCTs). This second installment focuses on how sponsors can handle different regulatory requirements for investigational products (IPs) (which can include drugs, biological products, and devices) and patient data.
The successful management of drugs and data involves understanding distinctly different expectations from regulatory authorities, particularly when trials span both U.S. and European regions.
How investigational product management differs between regions
The FDA and EMA take different approaches to managing investigational products and drugs outside traditional clinical settings.
FDA focuses on product characteristics: The FDA bases its requirements on the nature of the product itself. Their guidance indicates that suitable drugs for decentralized delivery typically have:
- Well-understood safety profiles
- Simple administration procedures
- Minimal preparation needs
The FDA cautions against direct shipment for drugs that require specialized handling, shipping, or storage conditions. Their guidance requires protocols to detail how trials will maintain product integrity and stability during shipment to participants' homes.
Key responsibility distinctions under FDA guidance: The investigator maintains primary responsibility for drug administration, ensuring that any IP administration occurs under their supervision or that of a qualified sub-investigator.
Investigators must also verify that participants have access to appropriate local medical care when needed. Meanwhile, sponsors bear the broader responsibility for patient safety in DCT settings, including the critical decision of whether a particular investigational product is suitable for administration outside traditional clinical sites.
EMA establishes specific procedural requirements: The EMA provides detailed procedural specifications for home delivery of IPs. Their guidance mandates that sponsors must:
- Assess and ensure how the appropriate storage conditions of the IP can be met, and whether the IP is suitable for administration at participants’ homes
- Provide clear usage instructions
- Verify proper storage capability as required, such as for temperature-sensitive products
- Ensure that the medication is received at home by the trial participant (or an authorized representative if the participant is not available).
This final requirement represents a significant difference from the FDA approach and affects how sponsors structure European trials.
Data management requirements reveal different priorities
Decentralized clinical trials shift extensive data collection from the investigator or investigator's site to study participants, their caregivers, and service providers (e.g. home nurses). The use of multiple systems and parties adds complexity and requires adequate oversight and implementation of appropriate measures by the sponsor.
While both agencies demand data quality and integrity, their specific requirements reflect different regulatory priorities. Both FDA and EMA clinical trial regulations require data management plans and risk-based monitoring, though the specific emphasis differs.
FDA prioritizes comprehensive management plans: The FDA requires thorough documentation of how trials manage data throughout the study. Their guidance calls for:
- Data origin and data flow from all sources to the sponsor (similar to EMA requirements)
- Methods and technologies used for remote data acquisition
- Service providers involved in data collection, handling, and management
The FDA recommends risk-based monitoring approaches and the use of centralized monitoring to identify and proactively follow up on missing data, inconsistent data, and potential protocol deviations that may suggest systemic errors.
EMA focuses on data flow visibility and access control:
The EMA takes a structured approach to managing these complexities. Their guidance specifically requires sponsors to ensure that all parties involved in the clinical trial have an overview of the data flow. A data flow diagram with additional explanations in the protocol is highly recommended, though not mandatory. Additional critical requirements include:
- Data credibility, reliability, and verifiability according to ICH E6 standards
- General Data Protection Regulation (GDPR) compliance, requiring adequate protection of personal data at every process step
- Minimizing the risk of erroneous data entry for data measured and entered directly by trial participants, especially on primary, key-secondary, or safety endpoints through appropriate measures
Both agencies stress that data quality, integrity, and traceability remain essential regardless of collection method.
GDPR adds complexity to trials with EU citizen participation
Trials in which an EU citizen is participating face data protection obligations under GDPR. The EMA guidance explicitly incorporates these requirements, and sponsors must address several key areas of GDPR compliance:
- Restrict data access to authorized personnel based on job function
- Collect only personal data necessary to fulfill required services
- Store patient data only as long as necessary for compliance and legal purposes
- Establish controls to manage and encrypt personal data in systems
- Perform regular audits to track data access while protecting personal information in audit trails
These GDPR obligations touch every aspect of trial execution from how sites recruit participants to how sponsors store data long-term. Trial protocols must address these requirements to gain approval in European countries.
How Suvoda supports sponsors
The Suvoda Direct-to-Patient Shipment Module allows sponsors to easily opt in or out of home delivery on a per-visit basis via self-service functionality.
Suvoda IRT also enables encrypted data sharing in a blinded manner, allowing only authorized data processors to access patient-sensitive data when absolutely necessary. Its integration capabilities keep operations streamlined by integrating into existing systems and managing the data flow associated with DCTs.
Additionally, Suvoda eConsent accommodates both FDA and EMA requirements by offering flexibility for EU member state specifics, supporting both electronic signatures where permitted and wet-ink uploaded PDFs where required, ensuring compliance across different regulatory environments.
How sponsors can navigate these differences successfully
Product management requirements from the FDA and EMA reveal stark regulatory contrasts. The FDA focuses on product characteristics, in that simple products with well-known safety profiles work well for decentralized delivery. The EMA requires detailed procedures: risk assessments, authorized recipient verification, and specific storage evaluations at participants' homes.
Sponsors can navigate these differences by building systems that meet the more stringent requirements globally—typically those from the EMA. When Investigational Product (IP) tracking, data documentation, and security measures satisfy EMA standards across all sites, sponsors create consistency and compliance. This approach eliminates parallel systems and reduces operational complexity during trial execution.
Author
Henk Dieteren
Clinical Supply Chain Solutions Consultant