Clinical research is complex, and rightfully so. What we do is often uncharted and difficult. Managing science, regulations, organizational and human behavior, and much more - it's a delicate and serious balancing act.
The central navigation tool of a clinical trial, at least in theory, is the protocol. Trial design may appear simple; however, with the complexity of operationalizing clinical research, it often requires a myriad of supporting documents, manuals and brochures, and other homegrown tools amounting to the Rosetta Stone. Translating and transcribing a clinical research protocol is not for the faint of heart. Ask any research coordinator. Whether it’s reconciling conflicting information, navigating a monstrosity of footnotes, or sifting through too many layers of detective work, protocols are complex and do little to prevent deviations.
During six years of analyzing over 1,250 protocols grade I-IV, RWE, and beyond, I gleaned some common themes regarding complexities, deviation risk, and inefficiencies. Let’s walk through three mistakes that typically lead to confusion, complexity, and unnecessary costs in clinical research.
Mistake 1: Footnotes, Footnotes, Footnotes
Love them or hate them, footnotes are a ubiquitous tactic for operationalizing a research protocol because ironically enough, the Schedule of Assessments (SOA) actually does an inadequate job of laying out a set schedule. Footnotes are intended to describe further details and exceptions that cannot be practically incorporated into an SOA. Footnotes come in many flavors, and I have noticed that even over the last 10 years, we have become more creative in how we stitch in ancillary pieces of information to the SOA. Here are three flavors of discrepant footnotes:
- Footnotes often conflict with the SOA itself. In extension/long-term follow-up visits, I often see a visit in the SOA labeled “q6 month” or something similar, but activity “T” only needs to occur “q12 month.” But because of the way that the visits are set up in the SOA, the footnote reveals a nuance that could be solved by simply breaking out the q6 month visit into a q6 and q12. In this case, the footnote adds critical information, but it isn’t delivered in a way that is preferential to someone operationalizing the trial at the site level.
- Footnotes often come into play too late. The true order of operations is often revealed in footnotes; while a veteran CRC may manage reordering tasks with less difficulty, a new-to-the-game, stressed-out CRC can easily miss a detail like this, creating panic in front of a patient and reducing confidence.
- The never-ending hamster wheel. Protocols and ancillary manuals are notorious for pointing to one place that points to another and then another. Oftentimes, footnotes create a hamster wheel effect, round, and round to find information that’s critical to carrying out a protocol as the sponsor intended.
Mistake 2: Not so elementary, dear Watson!
Piecing together ancillary documents is detective work.
CRCs wear many hats. While detective skills are a great characteristic for anyone in research and healthcare, they shouldn’t be the core skill set of a study coordinator. Unfortunately, with most protocols, it is. Here is an example:
This excerpt calls the CRC to a different part of the protocol from a footnote, yet ultimately does not give them the information they need. The best way to solve this would be to serve up the actual equation at the time that the CRC needs it, removing complexity and creating efficiency.
Reflecting on Mistakes 1 and 2, it’s interesting that neither of these problems are inherently ‘complex’ to solve. The science itself is much more complex. The solution is simple: provide clarity at the right place at the right time.
Mistake 3: Does the Perfect SOA Exist?
You would never combine your whole week of dinner recipes into one big recipe; rather, you’d have seven recipes for seven dinners. Protocols are no different. Each visit should be treated like its own recipe, with only the ingredients and instructions required to execute that meal, no more, no less. One of the many features of our Site Comms product creates individual workflows for each study visit, allowing the coordinator to clearly see all of the relevant elements they need to attend to it to execute a visit while the patient is in front of them.
There is a lot of nuance in even one research protocol. Now consider: CRCs are running Visit 3, Protocol A at 9 am, and then Visit 5, Protocol B at 11 am, and then Visit 1, Protocol C at 3 pm. The next day it’s all different. Visits and patients for Protocol D may be months or even years apart. It is impossible for CRCs to keep all these visits and protocols straight - not because they are incompetent, but because they are overwhelmed by confusing content. They deserve (and need) the right tools to run a protocol the way it was intended.
Protocols that require deciphering ultimately hurt all of us: sponsors, sites, patients, and everyone who stands to benefit from the investigational product or device in the future. We risk losing time and money and, ultimately, scientific progress in the industry. Clinical research has a lot of stakeholders and requires all players to do their part in a smooth, timely manner. We are all part of clinical research for the same end goal: to efficiently bring the best medicines to market through rigorous scientific execution.
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