How Practical Is FDA’s HCP Approach in DCTs?

The FDA’s latest guidance on Decentralized Clinical Trials (DCTs) marks a pivotal shift in the clinical research landscape. This transformative approach seeks to decentralize clinical trials by broadening the spectrum of participant access and leveraging the advancements in digital health technologies (DHTs). By extending trial-related activities beyond the confines of traditional clinical settings into participants’ homes and local healthcare facilities, the FDA aims to minimize travel burdens, enhance participant diversity, and improve trial accessibility. This article delves into the nuances of the FDA’s recommendations, exploring the integration of local healthcare providers (HCPs) into DCTs, the pivotal role of technology, the challenges, and the potential benefits of utilizing established infrastructures like retail pharmacies and core labs.

FDA’s DCT Recommendations to Decentralize Focus on Expanding Participant Access

In the FDA’s guidance for DCTs, a significant emphasis is placed on diversifying and facilitating the conduct of clinical trials by extending activities beyond conventional settings. This approach advocates for leveraging local healthcare facilities and using technology in participants’ homes to diminish travel constraints, broaden participant diversity, and enhance trial accessibility.

• Facilitating Broad Participation: The FDA advocates for a broadened scope of trial activity locations, including participants’ homes or local healthcare facilities, to mitigate travel burdens and enhance diverse recruitment: “In a DCT, some or all trial-related activities will occur at locations other than traditional clinical trial sites (e.g., the participant’s home or local healthcare facilities).” (Section III.A, DCT Design).
• Telehealth and Remote Visits: Encouraging the adoption of telehealth, the guidance provides flexibility in how trials are conducted, potentially reducing the need for in-person interactions: “In general, investigators can consider telehealth visits instead of in-person visits with trial participants if no in-person interaction is needed.” (Section III.B, Remote Clinical Trial Visits, and Clinical Trial-Related Activities).
• Involvement of Local HCPs in Trial Activities: Recognizing the value of local HCPs, the guidance endorses their involvement in in-person trial activities, thus leveraging proximal healthcare resources: “Depending on the trial protocol, in-person visits and trial-related activities may also be conducted by HCPs who are located close to trial participants’ homes but are not part of the trial personnel.” (Section III.B, Remote Clinical Trial Visits and Clinical Trial-Related Activities).

• Delegation to Local HCPs and Training Requirements: The FDA’s guidance outlines a flexible approach to the delegation of trial-related activities to local HCPs, ensuring they can effectively contribute to DCTs while maintaining adherence to GCP standards. Specifically, the guidance states: “When permitted by the trial protocol, investigators may delegate trial-related activities to local HCPs… These procedures may take place at participants’ locations or other local health care facilities as specified by the trial protocol. Trial-related activities that are unique to research and/or require a detailed knowledge of the protocol or the investigational product (IP) should be performed by qualified trial personnel who have been appropriately trained. When applicable, both trial personnel and trial participants should be trained on how to conduct or participate in a telehealth visit.” (Section III.B, Remote Clinical Trial Visits and Clinical Trial-Related Activities).

Using DHTs in DCTs Makes Sense

DHTs in DCTs offer significant benefits, enhancing participant engagement, inclusion, and data collection efficiency. By enabling remote monitoring and data acquisition, DHTs facilitate broader participation across diverse geographical locations, reducing the need for travel and making clinical trials more accessible to underrepresented populations. This technology-driven approach ensures high-quality data is collected in real-time, directly from participants, improving the accuracy and reliability of trial outcomes. Additionally, DHTs support a patient-centric model of trial conduct, prioritizing convenience and minimizing the disruption to participants’ daily lives, thereby potentially increasing retention and adherence to trial protocols.

It is critical, however, to note that the FDA stresses ensuring that all trial participants have equitable access to these tools for effective data collection: “Sponsors should ensure that DHTs used in a DCT are available and suitable for use by all trial participants.” (Section III.C, Digital Health Technologies).

Leveraging Local HCPs Presents Challenges in DCTs, However

DCTs present distinct challenges, necessitating careful consideration and strategic planning, and it seems the FDA’s recommendations on leveraging local HCPs in clinical trials might not be well thought-out. Here are detailed insights into some of the challenges when using local HCPs:

• Training and Compliance with GCP Standards: To ensure HCPs unfamiliar with operating clinical trial procedures, comprehensive GCP training is required. This training can become especially important to maintain standards for data handling and adverse event reporting management to maintain research integrity. For example, a local nurse might need training on the specific protocol procedures, including making data corrections properly (if recorded on paper) and reporting adverse events, ensuring that their actions align with GCP standards.
• Auditing and Monitoring Complications: Since local HCPs are not required to be listed on Form FDA 1572, identifying their locations for FDA and sponsor auditing and monitoring can be complex. This lack of visibility could hinder ensuring compliance and data integrity across all trial sites. An example includes the difficulty in scheduling site visits or remote audits when the trial sponsor or monitors do not have direct listings of all engaged HCP locations. Additionally, the diverse clinic setup and infrastructures across varying local clinics around a study site can increase the monitor and auditor burden and resources spent on monitoring and auditing visits.
• Feasibility Assessments for HCP Locations: Before local HCPs can participate in DCT activities, their facilities must undergo feasibility assessments to ensure they can effectively conduct clinical trial activities they have been delegated. This includes evaluating the local HCP’s clinic infrastructure, equipment, and staff qualifications to meet trial needs. For instance, a local clinic delegated to dispense IP and conduct vitals will need to be assessed for its ability to store investigational products at the required temperature or to calibrate its equipment to conduct vitals and process blood collection samples. This presents a challenge, especially with local clinics that are not experienced or understand the stringent requirements to conduct clinical trial procedures.

Addressing these challenges requires a nuanced approach, including developing clear guidelines for HCP involvement, robust training programs, and effective communication and oversight mechanisms through technology. Ensuring that local HCPs are adequately prepared and that the trial infrastructure supports their activities is crucial for successfully integrating HCPs into DCTs, ultimately enhancing trial accessibility and participant diversity. Nonetheless, from a logistical perspective, incorporating HCPs into clinical trials introduces several complications and risks, particularly concerning clinical trial oversight.

Using Established Infrastructure in DCTs May Be a Better Option

Integrating established infrastructures with DCTs, such as retail pharmacies and core laboratories, presents a strategic approach to enhancing trial accessibility and efficiency. This model capitalizes on these facilities’ robust, existing frameworks to streamline trial operations, ensuring a blend of convenience, reliability, and regulatory compliance. Here are the key advantages of using such infrastructure in DCTs:

• Enhanced Access to Local Communities: Retail pharmacies and core labs, often situated within communities or easily accessible locations, offer unparalleled access to a broad and diverse participant pool. Their presence in urban and rural settings helps mitigate the geographical and logistical barriers often associated with traditional site-based trials, thus broadening the demographic reach of clinical studies.
• Ready-to-Use Infrastructure: Core labs and pharmacies have state-of-the-art, calibrated equipment for precise diagnostic testing and other procedures often used in clinical trials. Their capability to conduct routine procedures such as blood draws, and vitals, which are integral to many clinical trials, with precision and efficiency ensures high-quality data collection. This reduces the burden of protocol deviations related to uncalibrated devices and maximizes the chances of deeming the facility acceptable for clinical trials during feasibility visits.
• Scalable Operations with Existing Oversight Infrastructure: These establishments are designed to handle scalable operations, making them well-suited for the fluctuating demands of clinical trials. Furthermore, retail pharmacies and core labs operate under stringent regulatory oversight, ensuring compliance with healthcare standards (to maintain their CLIA/CAP licenses). This existing oversight infrastructure supports rigorous monitoring and auditing processes, aligning closely with the regulatory requirements of clinical trials.
• Streamlined Data Collection and Management: Leveraging pharmacies’ and core labs’ digital and logistical capabilities can significantly streamline data collection and management. Many facilities have electronic data systems and protocols for secure data transfer, reducing the complexity of integrating trial data from multiple sources. These systems help to facilitate better clinical trial oversight.

Summary: Reevaluating the Use of Local HCPs in Decentralized Clinical Trials

The FDA’s recommendations for DCTs mark a significant step toward enhancing trial accessibility and participant diversity. However, the practical challenges of integrating local HCPs into DCTs, such as ensuring GCP compliance, auditing, and monitoring difficulties, raise concerns about the feasibility and efficiency of this model.

As we navigate these challenges, leveraging established infrastructures like retail pharmacies and core laboratories emerges as a compelling alternative. These entities offer established, scalable operations with existing oversight mechanisms, ensuring a blend of convenience, reliability, and regulatory compliance. By focusing on these established infrastructures, the clinical research community can address logistical hurdles more effectively, making clinical trials more accessible while maintaining the integrity and oversight essential for successful outcomes.