Neglecting Clinical Research Coordinators? The Risks Sponsors and CROs Need to Know

Pharma companies now place more importance on becoming a research site's so-called “Sponsor of Choice” than ever before. 65% of sponsors consider it very important, up from just 14% in 2019, according to the 2023 State of Site Enablement Report.

But who’s choice are they actually vying for?

As you'll soon discover, it’s the site's Clinical Research Coordinators (CRC). It's they who are at the heart of the entire clinical research process. And the success of your trial is dependent on their hard work.

So, could you be inadvertently ignoring the most important players in your clinical trials?  In this chat with Dan Sfera, co-founder and Site Director at Yuma Clinical Trials, VersaTrial founder and CEO, Mike Wenger explores the importance of the research coordinator role and why failure to prioritize their needs is a huge mistake often made by sponsors and CROs. 

"A coordinator is on the bottom of all this stuff, doing all this heavy lifting," explains Sfera. Despite the vital role they play in the clinical trial process, CRCs often do not receive the recognition or voice they deserve. 

From the patient’s point of view, the research coordinators are the literal face of your clinical trial. "They are the front lines that are building that rapport and the relationship with that patient that's coming in week after week," adds Wenger.  Patients rely on CRCs to guide them through the clinical trial process and provide support and guidance along the way. This trust and rapport is crucial to ensuring that patients remain committed to the study and complete it in its entirety. No easy feat. 

Despite the importance of the CRC role, they often do not receive the support they deserve. According to a survey conducted by the Association of Clinical Research Professionals (ACRP) in 2020, 45% of CRCs reported having to work overtime to complete their job responsibilities, and 64% reported feeling overwhelmed by their workload. Additionally, 32% of CRCs reported experiencing burnout, which can have negative consequences for both the CRC and the clinical trial. 

Sfera likens CRCs to medical school residents, who are often expected to work countless hours, do as they’re told, and to persevere. “It's just not a smart way to run your study when they're the workhorse of the study,” he says. This is a major issue that study sponsors and CROs need to address, and fast. 

Sfera thinks that research coordinators deserve more recognition and support, but decision makers on the pharma side may not fully understand the challenges they face. "You've never been a coordinator...You have no idea how research works at the site level," he says.

Pharma and CRO leadership have certainly expressed good intentions, but is it mostly lip service? It can be tough to convince them to help coordinators save time because of a perceived lack of benefit to the sponsor themselves. "For some sponsors, there's a disconnect," adds Wenger. "It's not always clear to them how saving a CRC from countless hours of unproductive time will help them on their study specifically."

This mindset is misguided. It is important to make the coordinators' job easier because it will ultimately benefit the sponsor. “They’re going to do more for your study. That's why you need to focus on making life easier for these coordinators,” says Sfera. 

Case in point: When coordinators are overloaded, as they frequently are, and have to choose between screening patients for different studies, they will naturally choose the one that is easier for them to manage. 

“When the PI refers them to patients for one study and one for your study, and the coordinator only has time for one of those that day, guess which one they're screening?,” Sfera asks rhetorically. “They're screening the one where it's easier for them!”.

Of course the second patient eventually does get screened regardless. But Sfera points to a critical difference that most sponsors likely don’t consider. "Don't you want the majority of the coordinator's time and good energy when they're not tired going to your screening? And not the competitor's screening?”. In other words, by making the study easier for the research coordinators, Sfera suggests you’re more likely to ensure that your study is prioritized and gets the most attention among competing trials.

So, what can study sponsors and CROs do to prioritize the needs of CRCs? One solution is to invest in technology that simplifies and streamlines the clinical trial process to make their jobs easier. Companies like VersaTrial are building solutions that make it easier for coordinators and other site staff to manage their workload, improve productivity, and reduce the risk of burnout. 

Those technologies are also creating an opportunity for more engagement and collaboration between sites and sponsors in the form of in-app messaging and bi-weekly pulse surveys. These surveys  allow coordinators to provide regular feedback on their workload, the study process, and any issues they may be facing. This feedback can then be used to make necessary improvements and changes to the study. By allowing CRCs to have a voice and taking their feedback into consideration, sponsors can improve the overall study experience for site staff and their patients.

In addition to improving the study experience, regular pulse surveys can also help sponsors and CROs identify any potential issues before they become major problems. For example, if multiple sites are reporting similar issues or concerns, it can indicate a larger issue that needs to be addressed. By catching these issues early, sponsors and CROs can take proactive measures to prevent them from negatively impacting the study.

It's time to prioritize the needs of CRCs and give them the recognition and voice they deserve. Sponsors and CROs need to work with sites to ensure that coordinators have the tools and resources they need to conduct clinical trials effectively. This includes improving communication, streamlining processes, and reducing administrative burdens. By doing this, we can ensure that they are satisfied with their work environment and can focus on conducting the study with integrity, safety, and efficiency.