We spend a lot of time talking about complexities of clinical trials. But take a moment to consider, what actually is making things complex?
First, there is the fact that the number of clinical trials is skyrocketing. From 10 years ago when there were 100,212 trials registered with ClinicalTrials.gov, it is now projected that there will be more than 348,600 trials in 2020. The sheer volume alone puts pressure on research sites to support the needs of the industry.
Not only are there a lot more studies, clinical trial design is also a lot more complicated. “Master” protocols, including platform studies, umbrella trials and basket trials are becoming increasingly common and increasingly complex.
On top of it, clinical trial protocols are trying to accomplish a lot more. Take for example that study endpoints have increased 86% over the past 10 years, based on research from the Tufts Center for the Study of Drug Development (CSDD).
More clinical trials and more procedures per protocol mean increased workload for those carrying out clinical trials. Unfortunately, research staff are supported with antiquated methods in running these trials, which is quite contradictory to the efforts to gather more data and validate more endpoints.
For example, one way study teams have tried to assist research staff with heavy workloads is with protocol quick reference guides, also known as trial "cheat sheets.” The rationale is that these tools help research staff to more quickly and easily find the information they need to perform a specific task without reading the full protocol each time or referring to their own memory of the protocol. These guides do not replace a full protocol or other study manuals, but they do provide a supplemental way to deliver information.
To find out how research site staff interact with the clinical trial protocol quick reference aids, Teckro teamed up with the Tufts CSDD to capture feedback from 228 respondents. The results are published in Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices.
Here are some of the results related to quick reference tools:
I think we can say that these quick reference tools can be somewhat helpful. However, the responses indicate that they are incrementally beneficial to site staff, meaning there isn’t a dramatic time saving or effort reduction with these tools. So you might ask why are we calling them “quick” reference tools?
There’s also the time and effort to create quick reference guides. Given that the majority are coming from study teams, it does show a bit of a disconnect in what the study team deems helpful versus what people in the field actually find helpful. I’m sure they are created with best intentions, but the practical reality is that this time and effort to create these tools isn’t substantially improving the situation for research staff.
Let’s take the case of one study coordinator assigned to 20 trials who has one patient eligibility criteria cheat sheet per trial. And let’s say he or she references each sheet 25 times over the course of each study. If we are conservative and say it takes five minutes to find an answer, that’s 42 hours spent getting answers to questions just related to eligibility. That is more than a standard work week – a lot of time for someone with an already heavy workload.
Some could argue that the schedule of activities (SoA) table within the protocol is somewhat of a cheat sheet for information regarding the required procedures or assessments for each study visit. It’s certainly easier to navigate than accessing the full protocol when someone would have to review the table of contents to find the page number for the study procedures section, scan for a specific visit number, and then read the content located within that section. This can be useful when the table is only a page or two in length; however, it’s not uncommon for SoA in complex protocols to span across 20 plus pages. All of a sudden, our “quick reference tool” takes the form of another stack of papers.
Let’s not forget another complication: protocol amendments. For a given clinical trial, it is not uncommon for multiple amendments after the study initiation. In fact, nearly 77% of Phase II trials and 66% of Phase III trials require two or more protocol amendments over the course of the trial, according to Tufts CSDD data.
There is a risk that quick reference guides are not being updated, resulting in study non-compliance which could impact patient safety and quality of the trial data. Also, when information is found in multiple locations (i.e., full protocol, cheat sheet with select protocol information, etc.), it increases the chances of discrepancies.
Rather than incrementally better, we believe research staff need something substantially simpler and easier. We’re talking about finding answers immediately – never mind measuring in minutes. And answers are only from the latest study information all in one place that is easily and quickly accessible in order to reduce risk and duplicate effort.
This is our vision at Teckro. And it’s happening now at research sites around the world. In Part 2, I’ll go through how Teckro is the ultimate version of a 21st century quick reference tool.