Local HCPs in DCTs: Big Benefits, Bigger Burdens?

By Dan Schell, Chief Editor, Clinical Leader

There’s been no shortage of opinions around the FDA’s DCT guidance, especially when it comes to the integration of local healthcare providers (HCPs). This use of local HCPs in DCTs has been described by some people as a transformative opportunity, but one that comes with complex operational challenges. So, I thought I’d take a closer look into the details of this topic and the common concerns.

Why Are We Talking About HCPs & DCTs?

The benefits of using these additional providers tend to mirror those often cited for DCTs in general. For example, HCPs can serve as trusted points of contact for participants, helping to foster stronger engagement and retention by providing care in familiar settings such as local clinics or even patients’ homes. You can also reach more participants, especially in underserved or rural areas, thereby improving the diversity and generalizability of trial data. And of course, this model reduces participant burden, making it easier for individuals to take part in trials without traveling long distances or disrupting their daily routines. All of those benefits support the FDA’s guidance that emphasizes patient-centricity by promoting trial designs that prioritize participant convenience, accessibility, and engagement.

What The Guidance Says

The guidance states that, when permitted by the trial protocol, investigators may delegate trial-related activities to local HCPs. Those “activities” can take place at a participant’s location (e.g., home) or other local healthcare facilities as specified by the protocol. (That’s about as patient centric as you can get!)

The key is, the HCP only can provide services that are part of their routine clinical practice. Think physical exams, vital sign measurements, blood draws, and even dispensing of IP if that’s within their scope. As such, they don’t need detailed knowledge of the IP or trial protocol. However, they should receive adequate training on the specific procedures they are delegated to perform, including data collection methods, safety reporting, and any relevant aspects of the protocol. Also, local HCPs are not considered investigators or sub-investigators, which means they don’t need to be listed on the 1572 or IDE list of investigators.

Justifiable Concerns

Let’s face it; this is a shift in the way things are normally done in the clinical trials industry, and this isn’t an industry that is known for embracing change. Still, most companies in the industry now view decentralized approaches as a core component of future clinical research, with the market expanding rapidly and adoption rates increasing across various therapy areas.

There are still concerns, though, and I understand why. Anytime you introduce a new element to a trial protocol, you run the risk of making that trial more complex, which is a tough pill to swallow (no pun intended) even when there are undeniable benefits to be had like those mentioned above.

There’s an underlying burden of oversight that comes with adding more cooks to the kitchen with any type of trial. Since the PI is ultimately responsible for, well, pretty much everything related to the trial going off without a hitch, including participant safety, they are expected to review data collected by local HCPs and ensure activities are performed according to the protocol and regulations. However, the guidance does state that sponsors are responsible for ensuring any network of local HCPs used for contracted services are qualified to perform the delegated activities. This includes ensuring proper credentialing and qualifications. All of that means more work for PIs and sponsors.

It doesn’t stop there, though. There needs to be a plan for the initial training and ongoing education of the HCPs. Even if it’s not a detailed explanation of the trial’s nuances, you still have to document their contributions to the trial and that they understand the regulatory requirements. Then there are the challenges associated with informed consent, data privacy, and adverse event reporting in a decentralized environment. Even before involving local HCPs, their facilities may need to undergo a feasibility assessment to ensure they have the necessary resources and capabilities to conduct the delegated trial activities (e.g., proper storage for IP, calibrated equipment). Coordinating IP shipments and data integration from multiple sources are other examples of the layers of complexity that can be added to the trial management process for these trials.

This heightened responsibility raises questions about how investigators can effectively oversee HCPs who may be geographically dispersed, have varying levels of research experience, and operate under different institutional standards. The risk of inconsistent data collection and protocol deviations is a significant operational worry.

Emerging technologies, such as portable imaging devices, may further expand the scope of what local HCPs can do, provided that validation, training, and secure data transmission protocols are in place. However, again, the more responsibilities added, the greater the training and oversight burden. And you don’t want to limit the HCPs who can participate to only those who are technologically adept.

You’ll Need More Documentation & Communication

There’s a reason why every trial isn’t incorporating DCT elements. Well, actually there are plenty of reasons, but the one I’m stuck on is rooted in the concept that if you want to reap the rewards, you have to do the work. And there is extra work, especially when incorporating local HCPs.

I’m not going to give you a long list of everything that you can and should do, but I will say much of the work you’ll be saddled with will revolve around maintaining good documentation and ongoing communication. Here’s a few bullet points you can use as a checklist:

• Establish clear contractual agreements with local HCPs outlining their responsibilities, compensation, and data privacy obligations.
  • Ensure timely and appropriate compensation for the services provided by local HCPs. You want them back, so pay them on time.
• Implement a centralized system to verify the credentials, licenses, and professional standing of all participating local HCPs. (See how to do this in my article, 7 Steps To Manage Local HCPs In A Decentralized Trial.)
• Develop SOPs for tasks performed by local HCPs to ensure consistency across different locations.
• Establish clear and consistent communication channels, such as regular virtual meetings, email updates, and dedicated communication platforms.  
  • Assign a central study team member (e.g., a CRA or a dedicated DCT coordinator) to serve as the primary point of contact for all local HCPs.
• Implement remote monitoring strategies to oversee the activities of local HCPs, including regular review of data, video conferencing for site visits (where appropriate), and remote data verification.
• Actively solicit feedback from local HCPs to identify challenges and areas for improvement.

I get it; when considering the integration of HCPs into DCTs we’re often attracted to the “shiny things” — patient centricity, trial accessibility, diversity, etc. Soon, though, the buzzkill of the operational, regulatory, and quality challenges sets in, and you’re faced with deciding if the extra work is worth the potential progress. Yeah, that’s a decision ClinOps folks are faced with in every trial, but that doesn’t make it any easier. Maybe proactively working on some of these bullet points now is the best plan, because the strategy of incorporating DCT elements into trials isn’t going away.

For more information on DCTs, check out our Guide For Managing Decentralized Clinical Trials.