Sites play an essential role in the successful delivery of decentralized clinical trials (DCTs) - yet they often get left out of the conversation when it comes to study design.

When sites agree to participate in a DCT trial, they must rethink every aspect of the trial delivery, from staffing and technology, to recruiting strategies and budget requirements. It is a lot to ask, and sponsors need to consider their needs when planning these trials.

“The sites are the experts,” says Kerry Gorman, Senior Director of Strategic Site Solutions for the US and Canada at IQVIA. “They are the ones who will give us the feedback on what the overall experience should be.”

Gorman recently joined a panel to discuss how DCTs impact the role of sites including new challenges and the additional support they need to deliver successful trials. Other panelists included Kelly Sanford, Global Head of Site Operations for IQVIA DCTs and Mike Ranella Senior Director of the Fast Forward Medical Innovation Business Development Team at the University of Michigan.

	Katy Preciado, Director of Decentralized Clinical Trial Solutions at IQVIA		Kerry Gorman, Senior Director, Strategic Site Solutions at IQVIA
	Kelly Sanford, Head of Site Operations, Decentralized Trials Solutions at IQVIA		Mike Ranella, Senior Director, Business Development at University of Michigan Medical School

Here are the "learnings from the field" on what successful decentralized clinical trials look like and how DCT solutions can help foster successful partnerships among sites, sponsors, and patients:

Trial designs often occur in silos and rely primarily on strategies that worked in the past. Does that need to change for DCTs?

Gorman: We can be more collaborative in this area. Design protocols are becoming more complex, and sponsors may not always consider their impact on the site and the patient. I hear from sites that they want to give input on what is practical and what will lower the burden for sites and patients.  IQVIA has begun inviting sites to provide input on protocols, but it's not happening consistently. And we need to do more of that.

How do you address technology challenges for sites that are new to DCTs?

Ranella: Each site will have a different level of experience, so you can’t come in telling them how to run a DCT. They may already have solutions in place. If you require them to adopt your technology, it may confound the execution process.

The best approach is to do due diligence on both sides before making these decisions. That is why sponsors should engage with sites early in the design process to understand their experience to determine the best approach for an upcoming trial.

Sponsors engage with sites early in the design process to understand their experience and determine the best approach for an upcoming trial.

Sanford: The logistics of decentralized trials are different and need to be worked through in a way that is approachable and engaging with the sites early to assure that it can work for everyone.

How do you address new training and staffing needs?

Ranella:  We have found that the traditional staff model is not always required for DCTs. Sites still need individuals with strong knowledge of the regulations and good GCP practice. Still, they also need to know how to troubleshoot the technology challenges likely to be faced by the patient population. It is essential to recognize the differences there and plan accordingly.

Patients are becoming familiar with digital tools in the care process, and many patient portals lead to more interaction.

Sites also need to understand how they will engage with patients remotely. Many investigators think they are losing something by not being face-to-face with patients. But patients are becoming familiar with digital tools in the care process, and many patient portals lead to more interaction. Patients can respond to the physician team and get answers to questions in real-time. We've been able to keep patients engaged in long-term follow-up studies for years using these tools. It is a different way to engage, but once sites have had that experience, it’s easy to see the value of engaging with participants beyond the traditional site visit.

How are DCTs changing the budgeting process and revenue proposition for sites?

Gorman: Staffing and budgeting for DCTs have been a learning experience, and it is still evolving. Budgeting will include a lot more support for additional personnel hours and new tech-focused staff who can support patients as they progress through the trial.

Ranella: The investment piece for sites is not to be understated. It will involve new hardware, new software, and new people. But it can pay off. The primary advantage of a DCT is that sites can serve a much larger volume of patients. Instead of recruiting five subjects for a trial, they could recruit 500, and they may only need a handful of full-time staff.

It does require changes to personnel and the way the site accommodates trial deliverables. So, it is important that sites can articulate the cost and value proposition for a specific project.

Once a DCT is launched, how do you maintain effective oversight of sites?

Sanford: As part of our DCT site selection process site, we meet with investigators to discuss how we can best serve them throughout the trial execution. Then we put a coordinator on the delegation of authority log, and they are delegated specific responsibilities by that investigator. This ensures regular feedback between the coordinator and the site, which alleviates some of the concerns about oversight.

What advice would you offer sponsors on working with sites to ensure the most productive DCT environment?

Ranella: Having multiple voices in the room to consider the problems a site will face will lead to designs that are compliant and meet the needs of the site staff and patient cohort. If there's a willingness to work together, that's the key.

Sanford: You must meet sites where they are in terms of their ability to execute the study. That can look different depending upon whether it’s a large academic center or a smaller site. Engaging the sites early on is the best way to ensure your plan can work.

Gorman: We’ve learned a lot of lessons about DCTs in the last two years, but it’s still early days. Some sites still need a lot of support and mentorship from those further along, like the University of Michigan. If we can help sites navigate this journey and introduce some standardization and interoperability to make these trials effective, it will alleviate a lot of anxiety about the future.

To hear the full panel discussion, check out A Sponsor's Guide to Effective Site Partnerships in DCTs: Learnings From the Field.