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Control vs. Constraint: Standardization and Templates in Protocol Development (Part 2 of 3)


Life sciences organizations need to balance standardization with flexibility within protocol templates to ensure a high-quality outcome.

Proven techniques for process improvement, like Lean Six Sigma, say that if you identify waste in a process, you should remove it by standardizing and controlling as much as possible. These improvement techniques were born from efforts to make production lines more efficient, and produce as many identical products as possible in the shortest amount of time. 

But unlike most initiatives, the goal of the protocol process is to produce a single unique protocol at the right quality at the right time. It’s also usually a one-time activity for an individual trial team. So while some degree of control and standardization is necessary to reduce the time it takes to produce the final output, applying too many controls can, in fact, be counterproductive. 

In the first article of this series, we discussed the importance of identifying key metrics within the protocol development process to target areas for efficiency improvement. In this instalment, we’ll look at how organizations can achieve the right balance of control and quality in their protocol development process.

A Closer Look at Templates

Let’s explore this by discussing the most common approach to controlling the protocol development process: the use of a protocol template. 

Templates provide a framework for incorporating all the required content for a protocol in a consistent structure. A typical template also includes some standard structural text, which can be a great timesaver for authors, and because the text is essentially preapproved, it can also speed up the review and approval processes.  

Because of these benefits, many companies attempt to standardize more and more of the document content, and apply additional control by using technology interventions to either prevent the standard text from being updated, or to identify where it has been changed. Although this may seem like a sensible measure to maximize time savings, this approach can lead to negative outcomes, including:

  • Increased overhead of governance and maintenance of the standard text elements. The standard text must be reviewed regularly to ensure it remains fit for purpose, and updates must be pushed out to the relevant template to ensure all new documents use it. If the text becomes outdated and remains in use through the templates, it will propagate low-quality content to all trials.

  • Time and financial impact of enforcing the controls. Resources will be needed to check the content as well as develop, maintain and support technical controls. 

  • Decreased usability of the template. Applying technical controls within a typical Microsoft Word template will often mean users need to deal with advanced features or even custom add-ins to Word, resulting in a cumbersome user experience. If technical controls become too advanced, it could even result in training requirements before people can use the template.

Fine Line Between Control and Constraint

On the whole, “over-developing” a template and strictly managing its content and use can result in increasing effort above and beyond what is saved in the writing process. In fact, it could possibly cause delays in the writing process because of the negative impact on the user experience. We’ve heard protocol authors describe the use of their company’s template as “awkward” and “constraining.” The message is clear: When improvement efforts become constraints, the net result isn’t improvement at all.

Used judiciously, author “constraints” are certainly necessary to ensure final quality; however, it’s important to determine where text must be standardized vs. where it could be standardized. By paying attention to the additional overheads listed above, businesses can determine whether the implications of any text change are so serious that the effort of controlling it is worthwhile. Otherwise, giving authors more flexibility within a standard framework is likely to create a more enjoyable user experience, and lead to a higher-quality end product. 

This can be done by offering reusable text as a suggestion rather than as fixed mandatory text. Authors can decide for themselves whether the text is relevant and useful, and choose to reuse it or not. If they choose to modify the suggested text, this can actually lead to natural improvements in the quality of the text and avoid obsolescence of mandatory text.

Just the Right Touch

A successful protocol development process is one that guides participants through an unfamiliar activity and produces a high-quality but unique protocol for a clinical trial. Bottom line: Don’t treat your protocol development process like a production line that turns out identical products. After all, protocols are created, not manufactured, and choosing wisely how you implement control ensures your authors are being enabled rather than constrained. 

This article was written by Bob Brindle, a Venture Leader at Cognizant who is leading the development of the Cognizant Protocol Creator. Part 1 discussed choosing the right metrics to use for speeding the protocol development process. 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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