Falling Through the Cracks: A Site's Perspective on The Communication Crisis in Clinical Research

Ask any Clinical Research Coordinator about the significance of effective communication between clinical trial sites and sponsors, and they'll emphasize its crucial role in successfully conducting studies. And they'll probably reveal that they're simply not getting enough of it. This oversight can result in significant negative consequences for both study timelines and data quality.

So, why aren't more Sponsors and CROs prioritizing it?

CRAs are tasked with facilitating communication and information sharing between sites and CROs/Sponsors. However, they also face the same challenges as the sites: juggling multiple competing studies with limited resources. Consequently, overwhelmed CRAs are forced to prioritize which issues to resolve immediately, leaving others to be dealt with later (or, unfortunately, ignored), often to the detriment of the study.

In a candid conversation with Kristi Norton, Research Services Program Manager at the University of Colorado's Hemophilia and Thrombosis Center, she shared her own experiences that highlight the communication challenges faced by clinical research professionals, the roadblocks that prevent effective escalation, and the potential solution offered by VersaTrial.

The Major Dangers of Minor Data Inaccuracies 

Kristi recounts a situation where her patient experienced a seizure and was admitted to the hospital, requiring her to report a Serious Adverse Event (SAE) within 24 hours - which she diligently did. However, she later discovered that her study binder contained an outdated fax number, leading to a five-day delay in reporting and a subsequent major deviation that had to be reported to the IRB.

"[The Sponsor] gave me the wrong fax number, but that should never have happened. The burden is on them to make sure that if they've changed the fax number, they're giving us that information,” said Kristi. “And instead they took zero responsibility for that. It all falls to the site - your site ends up with the deviation. Sponsors need to be providing information in a way that makes sense for us, and it has to be constantly up to date. I shouldn't have to report a deviation because you didn't give me the right contact.”

Kristi's experience emphasizes not only the importance of accurate and timely information exchange between site and study partners but also the dependency on and relative shortcomings of sending mission-critical information via email. 

“I went back through my emails, just to confirm if I had maybe missed an update on the new SAE fax number, but no one ever sent me a new one,” she said. “It was just an Icky situation that made me very frustrated and I think if this was constantly updated, that wouldn't have happened.”  

Escalation Breakdown: The Real-World Impact on Data Quality

In another instance, Kristi faced complications with a sponsor-sourced mobile nursing vendor who was mislabeling twice-a-week blood draws. She found it challenging to communicate the arising issues to the CRO and sponsor, which led to numerous deviations.

Kristi recalls, "There were multiple deviations occurring, and I couldn't get the CRA to actually tell the sponsor this was happening, and nobody was escalating it within the CRO." Consequently, 116 deviations occurred before any attempt was made to address the problem. When finally questioned about the deviations, Kristi expressed her frustration, saying, "I was trying to tell you five months ago this was happening."

Having a direct reporting option outside of the CRO could have been beneficial, as Kristi explains, "The option to report an issue directly within VersaTrial and direct that information to the right person would have been really helpful because I couldn’t get to the Sponsor, and the CRO didn’t really understand what I was trying to say was going wrong."

The issue only received the attention it deserved when data verification and source review took place, revealing the full extent of the problems. As a result, many samples became unusable.

The entire experience left Kristi frustrated, emphasizing the need for better communication channels and escalation mechanisms between research sites, sponsors, and CROs, especially when things go awry. "I think it's so hard to get feedback back to a sponsor or a CRO when something's really going wrong," she concludes.

Sites Stuck in Support Loops and CRO Gridlock

In yet another example, Kristi revealed her ongoing struggle with a central lab system that is using electronic barcodes designed to streamline the blood sample requisition process. However, Kristi's experience with the system has been far from smooth. 

Despite following protocol, Kristi encountered a frustrating issue: "When I go in to do my e-requisitions, the form pre-populates with a visit date from November 2021”. This seemingly minor problem quickly spiraled into a year-long game of passing the buck.

Kristi reached out to the central lab system's help desk, only to be told that her issue was study-specific and should be addressed by her study team. When she contacted her study team, they directed her back to the lab's help desk.

Caught in a never-ending loop, Kristi finds herself stuck with no resolution in sight. She expresses her frustration: "I'm stuck in this loop. This has been going on for about a year. I can't do electronic requisitions, but I get a deviation every time I don't. And no one will fix the problem because they each say ‘talk to each other’."

This issue highlights a significant communication problem in clinical research. CROs often act as intermediaries between research coordinators and sponsors, making direct communication difficult, if not impossible. Kristi suspects that CROs might even be intentionally blocking access to sponsors to protect their own interests.

"I think that the CROs do that on purpose. They want us to not be able to reach the sponsors, but sometimes they're the actual problem, and so it can be difficult to know what to do. You just feel stuck a lot of times," she lamented.

Kristi's story underscores the need for better communication channels and accountability within the CRO, with clearer pathways to issue escalation. As professionals like her continue to face these challenges, the overall success and efficiency of clinical trials may be at stake.

A Win-Win-Win Solution Powered by Sponsor & CRO Buy-In

Kristi sees immense value in VersaTrial and believes it can significantly benefit research sites, sponsors, and CROs. She emphasizes that sponsors' buy-in is crucial: "The more sponsors that buy in, the better the system gets and the more it fulfills a need for us as coordinators. If you buy into this system, then what we need - we get. If they really do care about the site experience, then they need to understand that that's crucial. It's an excellent tool for me, but it's really not as useful if they don’t buy in."

She believes that the platform can not only keep the sites organized but also help them perform their jobs better, reduce unnecessary deviations, and facilitate quick access to support networks and accurate information."The organization part of VersaTrial really does have the capacity to make every one of myself and my team super organized with our studies," Kristi adds.

Referring back to her earlier SAE ordeal, Kristi discusses the VersaTrial platform’s ability to provide bi-directional updates to study contact details:  "The idea of having to ruffle through a binder and find a fax number when it's 11:00 pm and you just want to fax the dang thing in and go home, all of this is just unnecessary. There's so much room for error, and VersaTrial can solve that problem."

She encourages sponsors to consider the benefits of using a centralized system like VersaTrial, as it would not only streamline communication but also ensure that up-to-date information is readily available: "I think for sponsors it’s about having that peace of mind that they can provide the most up-to-date everything, information-wise, in a system where it's in one place and it goes out to all sites. That seems like that would make their lives way easier too.”

Kristi explains that with VersaTrial, study partners can eliminate the need for a convoluted chain of communication: "Instead of having to send an email to all of the clinical trial managers and then those managers send an email to the CRAs, and those CRAs send an email to the sites that they're in charge of. It feels like it doesn't have to be that complicated, but also it's instantaneous, so they can wipe their hands of it."

As illustrated by Kristi Norton's experiences, effective communication between clinical trial sites, sponsors, and CROs is vital to the success and efficiency of clinical trials. VersaTrial presents a promising solution to bridge these communication gaps, streamline information exchange, and reduce the risk of errors and deviations. By adopting a centralized system like VersaTrial, sponsors can ensure up-to-date information is readily available to all parties, improving overall trial outcomes. 

Don't let communication barriers hinder the success of your clinical trials—learn more about how VersaTrial can help enhance communication and collaboration today. 

💜 A special thank you to Kristi Norton from the University of Colorado's Hemophilia and Thrombosis Center for sharing her valuable insights and experiences, which greatly contributed to this article's depth and understanding.