Cari Kniola
Senior Director, Corporate Strategy

October 25, 2022

I recently attended my first Society for Clinical Research Sites (SCRS) Global Site Solutions Summit in Hollywood, FL. The atmosphere was jovial, collaborative and without pretense and is now one of my favorite conferences! Folks from investigator sites, CROs, Sponsors, and technology vendors were in attendance to discuss the challenges clinical research sites face and how we can make clinical trials better for them and our patients.

There were clear themes throughout SCRS’ conference about what sites were struggling with. Staffing is a huge issue, as it is for many companies across industries. Compounding this issue are the increased efforts needed at investigator sites to support ever-expanding trial technologies, coupled with the ongoing problem of sites not being adequately reimbursed nor reimbursed in a timely manner for the work they do. Add on top of this an increased focus on trial diversity and accessibility, and it sure seems like the water clinical research sites have been treading may just keep getting deeper.

So, what can we do?  These are big problems that are not new, but it feels like the concern from sites has escalated from a steady hum to an outright cry for help. Here are three things I took away from this year’s SCRS conference that we as CROs and Sponsors can try to do to help support our clinical research site partners.

Trial Technologies: Trial technologies and decentralized trial (DCT) components are not new. What is new is the recent DCT fervor and the sudden increase in available technologies, each one shinier and more sparkly than the last. These technologies do not run on their own. At the site, they require additional resources for training internally, training patients, patient tech support, new processes, not to mention the hundreds of passwords they need to maintain across studies. Many of the presenters at SCRS agreed that we can make this easier on sites when we:

• Involve them early in the conversation around what technologies are being considered for the study, so the impact can be understood and hopefully mitigated prior to study start.
• Understand that when the technology doesn’t work, the site is the one left holding the bag with the patient looking at them waiting to make things happen. This erodes the site/patient relationship the site is trying to build before they even get started. We can fix this by not only doing robust user acceptance testing (UAT) and ensuring the technology works as intended but including sites in that UAT so it is being tested by the actual end user.
• Provide optionality and flexibility. Whether that is letting the site use their own eSource or eReg Binder, or giving patients the choice between their own phone or a provided device, or even letting the patients choose if they come to the site or not for a visit that could be remote.
• Newsflash – when we refer to DCTs as ‘siteless’ trials, we lose favor among our research sites. We came out of the gate with messaging that set the ‘DCT movement’ and trial sites on an antagonistic path from the start. Let’s include sites in the conversation so we can find a way to make technology fit-for-purpose and a benefit to all involved.

Site Budgets and Payments: This is definitely not a new issue. There is some progress – during the conference SCRS reviewed preliminary results from their 2022 Site Landscape Survey and most clinical research sites are now being paid monthly rather than quarterly. Hooray! But there is still room for improvement.

• All of these fun technologies we want to use take time and effort to implement effectively at the sites. We will be seeing a reflection of this is in site budgets more and more and need to be prepared to include it in their payments.
• Amendments, reconsenting, changes in CRAs – these mid-study shifts in activities also result in additional work at the site. Feedback from the sites was that these routinely receive push-back when submitted for payment. Let’s stop pushing back and pay them for the work they do.
• Remote monitoring – sites have started including technology/eSource platform fees to account for what it takes to accommodate remote monitoring. It’s not less work. It’s just…different. And sites need to be paid.
• Are you sensing a theme here? Let’s pay our sites for their enormous contributions to our studies! We literally cannot develop these new treatments without them.

Trial Diversity: Trial diversity, or lack thereof, is also not a new problem. Whether the barriers be race, ethnicity, gender, ability, economic, or other in nature, for us to have the most robust and comprehensive clinical trial data that applies to everyone in our communities, everyone at SCRS agreed that we need to do everything we can to provide equitable access to clinical trials. Things we can do include:

• Provide patient stipends that not only cover transportation, but also the time a patient will take away from their job, to get childcare, for their caregiver to attend a visit as well. Many families are struggling financially, participating in a clinical trial should not add to that burden.
• Consider if the screening process and associated data considers our transgendered population.
• Help sites reach out to communities by sponsoring blood pressure screenings or health fairs, ways to be involved in education and equity BEFORE we need them to participate in a clinical trial.
• The upsurge in DCTs is meant to help improve diversity, but if we aren’t careful we could be creating another barrier to participation. Not everyone has access to internet, a cell phone, or is comfortable with technology.  When planning the use of our technologies, we need to make sure we are meeting the patients we want to enroll where they are.

When sponsors, CROs, and clinical research sites work together we can produce amazing results and provide new treatments for those who need it. At conferences like SCRS Global Site Solutions Summit the conversations keep pushing the needle forward – let’s keep the dialog going.

Thanks again to SCRS for an excellent Summit! Can’t wait until next year!