The concept of sludge provides an invaluable lens for clinical research professionals in identifying and mitigating unnecessary friction and bottlenecks.
In contemporary clinical trials, balancing the competing goals of scientific rigor, staff and site efficiency, and patient experience is often overwhelming. The increasing complexity of trial protocols, combined with the pressures to deliver timely results across expanding endpoints, presents a wildly entangled challenge. This is the Iron Triangle of Clinical Trial Complexity.
The concept of “sludge,” as introduced by Cass Sunstein, provides an invaluable lens through which we might reexamine and optimize this balancing act. Sludge refers to the excessive requirements, red tape, and unnecessary friction that individuals and teams encounter in various processes. Sunstein’s exploration of sludge aims to highlight the ways in which it can impede decisions, actions, and access to benefits or services, effectively acting as a barrier to efficient and beneficial outcomes. Sunstein suggests that implementing “sludge audits and sludge-busting” techniques can rapidly release these bottlenecks and barriers, and speed necessary behavior change.
In the world of clinical trials, sludge is every- where. Researchers struggle with complicated documentation and expectations (real and perceived) that rarely add value. Site staff need to execute overly complex and often unnecessary procedures. And patients are confronted with daunting paperwork filled with medical jargon, confusing information about the trial, and/or the challenge of getting to and from trial sites. This is sludge.
Two of the most common, real-world examples of sludge are modern informed consent processes and archaic site training and start-up expectations.
For patients, informed consent forms have become increasingly lengthy and complex, and filled with procedural explanations often unintelligible to the layperson. This complexity creates uncertainty, undermines psychological safety, and deters potential clinical trial participants, particularly those with lower literacy levels or limited health knowledge. This is sludge.
For sites and staff, while training in preparation for clinical study execution is critical, archaic approaches of full-day, one-size-fits-all, wholly passive, death-by-PowerPoint are both demoralizing and ineffective. This is sludge.
The combination of identifying sludge through audits and eliminating it through sludge-busting is a surefire path to success. So let’s simplify our playbook:
1. Establish clear objectives:
2. Gather and analyze data:
3. Involve stakeholders:
4. Prioritize areas for improvement:
5. Implement solutions and monitor results:
Keep in mind that a sludge audit is not a one-time activity but an ongoing process of refinement and improvement, and sludge-busting is a superpower.
Wrapping up
Looking at clinical trials through the lens of sludge helps us see where we can identify and mitigate unnecessary friction and bottlenecks. By focusing on making information clearer, simplifying procedures, using technology wisely, and listening to site staff and patients, we can make clinical studies more efficient and accessible. This approach doesn’t just speed things up; it also ensures trials are fair and open to everyone. By reducing sludge, we can make the path smoother for advances in medicine that benefit us all.
Brian S. McGowan, PhD, FACEHP, is Chief Learning Officer and Co-Founder at ArcheMedX, Inc.
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