The U.S. Food and Drug Administration (FDA) released draft guidance on decentralized clinical trials (DCTs) on May 2, 2023, as promised by the FDA Reauthorization Act (FDORA). This guidance aims to “support the use of DCTs in drug, biologic, and device trials, where some or all trial-related activities occur outside of traditional clinical trial sites.”1  

In part one of this two-part series, we discussed three essential takeaways from this new draft guidance. If you missed it, catch up here: 7 Essential Takeaways From the FDA’s Decentralized Clinical Trial Draft Guidance – Part 1

For part two, we’re going to cover the four remaining recommendations and what you need to do about them.  

4) Patient Identification in Remote Clinical Research  

A small but important detail: per the draft guidance, “investigators must confirm the identity of patients for every remote trial visit.”2 

5) Digital Health Technologies in Support of Clinical Trial Diversity  

Digital health technologies (DHTs) play a pivotal role in DCTs and hybrid trials. The FDA defines DHTs as “a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.”3 DHTs are essential for DCTs, as they enable remote data capture, electronic communications, remote patient interaction, and the transmission of data to and from patients, regardless of their location. 

The draft guidance emphasizes that DHTs should be “available and suitable for use by all trial participants,” a mandate that will ensure research diversity and prevent the exclusion of patients due to a lack of access to DHTs, such as those in remote communities with unreliable access to Wi-Fi or individuals from lower socioeconomic groups who may not have the financial means to afford smartphones, laptops, or tablets.2 By addressing these access barriers, the use of DHTs promotes equity in clinical trial participation and maximizes the potential for a diverse and representative study population. 

6) Software to Accelerate Decentralized Clinical Trials  

In DCTs and hybrid trials, where at least some trial-related activities take place outside the central site, ensuring the safe and secure transmission of trial data is crucial. The draft guidance provides two options for local healthcare providers (HCPs) to collect and transfer data to be included in the trial records:  

  1. Directly enter data into the electronic case report form (eCRF) 
  2. Upload forms or documents to the central site using secure data transfer methods, after which principal investigators (PIs) or other trial personnel will enter the data into the eCRF 

It’s important to note that software programs used for collecting and transferring trial records, as required by the FD&C Act and FDA regulations, must comply with 21 CFR part 11.4 This maintains data reliability, security, privacy, and confidentiality throughout the study process. 

While real-time video interactions, including telehealth visits, are considered live exchanges of information, they are not regarded as electronic records under 21 CFR part 11.2 However, local laws governing telehealth may still apply, and it is essential to ensure privacy, security, and proper documentation during these interactions. If such documentation is captured in electronic form, it falls under the purview of 21 CFR part 11.2 

By adhering to these guidelines, trial sponsors and investigators can establish robust data collection and transfer processes that maintain the integrity and security of trial records. This enables seamless collaboration between decentralized locations and the central site, facilitating efficient and reliable data management throughout the trial. 

7) PI Oversight for Clinical Trial Management  

Per the guidance, PIs are advised to only enroll the number of trial participants that they can “appropriately manage” to maintain satisfactory supervision of DCT activities.2 However, what the FDA considers an “appropriate” number of patients is not explicitly defined, leaving it open to interpretation. 

The guidance also suggests that investigators use videoconferencing and other similar technologies to facilitate oversight of trial personnel and activities performed at remote locations. However, investigational product (IP) that involve complex administration have a high-risk safety profile or do not have a well-defined safety profile, should only be administered to participants under the investigator’s personal supervision or that of a designated sub-investigator.2 Whereas IPs that have well-characterized safety profiles and that do not involve specialized monitoring during the immediate period following administration, may be appropriate for local HCPs or trial personnel working remotely to administer the IP at local healthcare facilities or participants’ homes. 

The guidance does not specifically address the physical proximity of the investigator to the patients, except when discussing IP administration. This leaves room for flexibility in determining the physical proximity required for other aspects of the trial, with the understanding that remote supervision can be utilized to facilitate effective management and supervision of trial-related activities.

Efficiently and Easily Meet DCT Requirements With Elligo Health Research®  

As stated in part one, navigating the complexities of DCTs can be challenging, especially with the added layer of new FDA guidance. At Elligo, we provide the necessary tools and support for DCTs and ensure compliance with the latest guidance, simplifying the process for sponsors and investigators. 

Our proprietary trial platform is another example. To maintain data quality and reduce variability, the new guidance emphasizes the need for quality control measures, such as regular review of participant data entered by contracted HCPs. Our IntElligo® Research Stack offers robust PI oversight capabilities that enable thorough review and assessment of data consistency and completeness. These measures ensure the reliability and integrity of trial procedures performed by local healthcare providers. 

Elligo also provides comprehensive solutions that align with the latest FDA guidance on DCTs. Our expertise, established processes, and innovative technology platform enable sponsors to overcome the challenges and complexities of decentralized trials, facilitating compliant and efficient research across diverse populations and geographical locations.  

Partner With Elligo for DCT Compliance and Excellence  

By working with Elligo, you can confidently navigate the complexities of DCTs while ensuring the highest standards of quality and compliance. Contact us today.  

1. FDA Takes Additional Steps to Advance Decentralized Clinical Trials. U.S. Food and Drug Administration. Published 2023 May 2.  
2. Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders. U.S. Food and Drug Administration. Published 2023 May.  
3. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders. U.S. Food and Drug Administration. Published 2021 Dec.  
4. Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application. U.S. Food and Drug Administration. Publish 2003 Aug. 

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