Addressing Current Challenges in the Site Landscape

Jimmy Bechtel, MBA

In this interview, Applied Clinical Trials catches up with the Society for Clinical Research Sites (SCRS). Jimmy Bechtel, MBA, VP of site engagement at SCRS discusses evolving challenges in the site landscape, what SCRS is doing to alleviate burden, as well as the organization’s upcoming event, the Global Site Solutions Summit in October 2023.

Applied Clinical Trials: One evolving challenge in the site landscape is the increasing complexity of clinical trial budgets. What is SCRS doing to alleviate this burden and assist sites in tracking their costs?

Jimmy Bechtel: We found that many sites are not accounting for all the costs associated with their trials. To guide this issue in a better direction, SCRS developed a Site Invoiceables Toolkit that contains a detailed overview of common billable items that sites should consider when assessing costs associated with a clinical trial. The document provides clarity to the terminologies of line item invoiceables that are not uncommon in budgets and should be considered for every study.

As a complementary document, SCRS also created an Invoiceables Calculation Spreadsheet that helps calculate the items described in the Site Invoiceables Guide. Both resources are designed to help guide and provide insight into common costs for conducting clinical trials. However, they do not indicate specifics such as when or how much to invoice, as this will depend largely on the budgetary needs of the site and individual protocols.

Too often, sites are not given the information they need in adequate time to make an appropriate assessment of their trial related costs, particularly when it comes to technology. Sites need all the necessary details as soon as possible in order to accurately cost conducting patient visits, especially with new technology elements being incorporated into the trial. We frequently host educational sessions on site finances in webinars, podcasts, and conference sessions to help sites understand all the unfunded, yet essential study activities—also called “hidden costs”—associated with their trials.

ACT: There is also the evolution of decentralized clinical trials (DCTs). What challenges are sites facing with this?

Bechtel: Although clinical trial technology solutions are moving in the right direction, sites still experience several challenges with decentralized technologies. Some of the most prominent concerns we hear are insufficient budgets to account for technology set up and training, lack of integrations resulting in duplicate data entry, nonexistent technology support, oversight of remote vendors, and excessive training obligations.

To put site training requirements into perspective, the 2023 SCRS Site Technology Landscape Survey indicated that 40% of sites are spending an average of 5-15 hours per month per trial on technology training. 25% of sites shared they are spending 15-20+ hours on training. Often, these trainings can be rudimentary and unhelpful for experienced sites.

Sites are also experiencing more frequent protocol deviations and screen failures related to technology. Currently, the investigator and/or site is still responsible for protocol deviations even when they are caused by the technology, not the site or patient. If the screen failure is caused by sponsor-supplied tech, it should not be counted against the site in their screen failure cap. Customer service at the vendor level should also be much more robust so roadblocks can be promptly addressed. This will help mitigate potential setbacks and prevent the loss of valuable time and study participants.

Most importantly, sites need solutions that can be safely integrated with one another if the goal is to help improve clinical trial efficiency and site sustainability. Technology solutions should have the ability to manage data from multiple sources, or at least integrate in ways that enable flexibility within that trial so sites and industry partners can maximize their time and resources. The growing need to discuss these ongoing concerns is why we created the SCRS West: Clinical Tech and Innovation Summit, which was held this June in Scottsdale, AZ. We received incredible feedback from the event and plan to host again next year.

ACT: Could you tell our audience about the task force SCRS has put together to address site staffing challenges and inflation?

Bechtel: In late 2022, SCRS interviewed several of its largest site networks about workforce retention and recruitment.The stories were so concerning that an SCRS Task Force was formed immediately to share insights and a call to action for the collective clinical research industry.

To start, the SCRS Workforce Taskforce released a toolkit created by several of its largest site network members to address the clinical research industry’s workforce setbacks and inflationary pressures. The Site Toolkit for Challenges in Workforce Retention and Inflation is available to SCRS member sites and offers best practices to maximize revenue, minimize costs, and recruit and retain employees.

A companion to the toolkit is an open letter to industry Sponsors and CROs, outlining current difficulties sites face with staffing and budgeting, and solutions urgently needed to address those issues. We encourage everyone to read it and share it with their industry colleagues if they have not done so already.

ACT: The Global Site Solutions Summit is coming up in October. What can guests expect for this year’s event?

Bechtel: The Global Site Solutions Summit is an opportunity to connect with a community of global clinical research professionals such as site leaders, investigators, regulators, CROs, solution providers, and sponsors. Nearly 1,300 attendees joined us last year, and we expect that number to grow! It’s truly a collaborative forum where industry stakeholders can have open discussions, forge meaningful partnerships, and share best practices and ideas to revolutionize the way we conduct trials.

This year’s agenda features a diverse range of educational sessions, Site Partnership Symposiums, and roundtable discussion, all curated to address solutions for better site-industry partnerships. From optimizing recruitment and retention strategies to implementing efficient data management systems, our goal is for attendees to gain actionable insights and practical tools to improve their operations.

In addition to our educational content, the Global Site Solutions Summit also hosts the annual SCRS Eagle Award Gala & Awards Dinner, where we celebrate the achievements and innovation of sites and industry partners across seven unique awards. This year, we are also launching the Global Site Excellence in Diversity Award which will acknowledge sites that have excelled in diverse, equitable, and inclusive trial recruitment. If you haven’t attended yet, it’s truly an event to remember! The event will be held October 6-8, 2023 in Hollywood, FL.

ACT: Looking forward, what are some other challenges SCRS is looking to help sites alleviate?

Bechtel: SCRS has recently launched a Site Payment Initiative to mitigate various financial hurdles sites face, such as holdback payments, patient stipend taxes, and delayed payment frequencies, among other objectives. The initiative is comprised of site leaders, sponsors and CROs committed to addressing financial burdens at the site level.

We also relaunched our Public Policy Committee which submits comments on behalf of sites to industry regulations and guidance, such as the recently released FDA Draft Guidance on DCTs, the Good Clinical Practice ICH E6(R3), and the Health Breach Notification Rule.

SCRS always keeps moving, and we will be releasing more resources for sites in regard to technology, workforce, budgeting and much more. We welcome everyone to join us at an upcoming Sites NOW discussion or one of our six annual Summits around the world to learn, share your experiences, and solve challenges impacting the clinical research industry.