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Metrics in Protocol Development: Are You Asking the Right Questions? (Part 1 of 3)


To streamline clinical trials, life sciences organizations need to use the right metrics for the protocol development process. This requires a new focus on how much effort is consumed, not how long the process takes. (This is the first in a three-part series.)

In a clinical trial, every day matters — and development of the protocol document is on the critical path, since the study of a promising new drug can’t begin without it. Many companies, however, can’t provide a precise answer to what seems like a very basic question

How long does it take to create a protocol document for a clinical trial? 

Since most companies track milestone dates in a clinical trial management system (CTMS), it seems like an easy calculation to do, using the time elapsed between the actual dates for milestones like first draft and final approved protocol. What we’ve found, though, is that these data points are of limited use. 

While the average protocol development time can be readily calculated based on the CTMS milestone dates, some companies actually feel their “real” average is represented by a different figure, derived by recalculating the CTMS average after removing a few outliers with very high values. These companies reason that some of the high values came from trials that had been put on hold for weeks or even months during the protocol development phase, pending decisions on funding or resourcing. 

This exposes a significant weakness in correlating process effectiveness with measures of elapsed time: the many external forces that affect elapsed time, few of which can be controlled.

Time for a New Metric

This is a critical topic. Since every extra day spent on protocol creation delays the start of the trial — and costs money — finding efficiencies is very important. But if businesses aspire to transform any process through a shift to digital, or streamline a process by identifying inefficiencies, they need a reliable baseline measure. Otherwise, how will they know whether their changes have made any real difference?

Perhaps they should be asking a different question to find their baseline measure:

How much effort does it take to create a protocol?  

Because protocol creation involves input from many people, total effort should be assessed by measuring the hours spent actively working within the total elapsed time. By starting to collect information that measures activity, or quality of activity, businesses will gain the best insight into areas of inefficiency in the current process. They’ll also have the best chance to identify changes that can make a real difference to total protocol development time.

The Protocol Review Cycle

As an example, consider the document review cycle, which can account for very large pieces of the total elapsed time. You may already have targets in place, such as “completion of the review of a draft version within 10 working days.” The fact that elapsed-time metrics show a review was completed on time does not necessarily tell you that the review process was effective or how much effort was involved. More valuable information to collect and measure could be:

  • How many people participated in the review? It can be difficult to keep track when copies of documents are e-mailed to multiple people and can be forwarded to others without the owner’s knowledge.

  • Did everyone who needed to review the document actually review it during that time? Or was the review period simply closed because time was up? 

  • Was the review of high quality, or did you end up with multiple rounds of review? Worse, did avoidable errors make it into the final version? 

  • How long did it take each reviewer to complete their review? It’s possible that Parkinson’s Law was in effect, which suggests that “work expands so as to fill the time available for its completion.” 

Collecting Metrics

To answer these types of questions, businesses will need to collect information directly from the participants in the process, but they should also be careful not to place any burden on busy trial teams by asking them to log their activities in exhaustive detail. 

The simplest approach could be to use a short interview or survey that members of the team complete at the end of their part of the process, while the relevant information is still fresh in their minds. At the time the protocol is being developed, study managers will know exactly how many review cycles were required, and will also likely have a lot to say about parts of the process that were particularly onerous. 

Setting Goals for Improvement

Businesses can use what they learn to benchmark their current targets for document milestone cycle times, and set realistic goals for improvement. Basing cycle time targets on the actual effort required to complete each activity leaves less risk for Parkinson’s Law to come into effect.  

Better still, businesses will clearly see the areas that are top candidates for improvement — ultimately ensuring that future digital-driven improvement projects will lead to genuine process improvement, rather than simply digitizing an inefficient process. 

This article was written by Bob Brindle, a Venture Leader at Cognizant who is leading the development of the Cognizant Protocol Creator. Part 2 will discuss standardization and control in the protocol development process as a mechanism for improving efficiency. Part 3 will look at how to ensure you’re creating usable content for various audiences and their varied purposes.

To learn more, visit the Cognizant Protocol Creator webpage.

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Metrics in Protocol Development: Are You Asking the Right Questions? (Part 1 of 3)