Your final protocol is ready for approval signatures, and you’ve delivered it on-time. In front of you on your screen could be 100-plus pages of detailed content, compiled by countless experts over several months. You may have followed the sage advice to collect information that tells you exactly how much effort went into creating that beautiful document.
Now answer this question: How do you know you’ve done a good job?
You could claim success because there were few review comments in the final round. You could say you did a good job because you beat all the deadlines. You may even have received positive comments during the review cycle about the quality of the document.
However, those metrics only tell you you’ve produced a good document. You will only learn whether the document is also valuable content when the trial is well underway and running smoothly and effectively.
That’s because while sending the signed protocol may be your final deliverable, receiving the signed protocol is the starting point for many other participants in the rest of the clinical trial process.
For most of the recipients, the protocol becomes an instruction manual that allows them to create or execute their particular part of the trial. These recipients will not congratulate you for your poetic prose or perfectly placed punctuation if they find it difficult to locate the single piece of information they need to kick off their first activity.
Same Protocol, Different Recipients
As noted in the first article in this series, most of the people involved in writing protocols would likely be doing it as a one-time activity. They don’t write protocols all day. But many other recipients will be receiving a steady stream of protocols because, for example, they’re responsible for setting up the trial in a standard system used by every trial your company runs. These people are your customers, and it is vitally important for them to find the information they need in the same place in every document, and to be able to trust that the content has the same meaning across all trials. That’s why standardizing text and using templates in protocol development will always be part of a well-designed process.
There are still other recipients of your protocol: regulators who will review and approve it, or sites that will eventually execute the trial. These people are receiving a steady stream of protocols from multiple companies. Each company may have followed its own internal standard template, but this will not help an external reviewer quickly interpret the content of your protocol compared with a protocol from another company.
That’s why it’s very encouraging to see the industry recognize this challenge from the viewpoint of an external stakeholder and take steps to address it through standardization initiatives, including the TransCelerate Common Protocol Template (CPT) and the NIH-FDA Clinical Trial Protocol Template. Even more encouraging is the fact that these standardization initiatives have recognized each other and will work to harmonize their content.
Although it would be almost impossible to find a single standard that works for all companies without any customization, CPT offers guidance on what should be kept as a true standard and what can be modified as necessary, striking a balance (as discussed in the second article of this series) that ensures the template is a helpful framework rather than a set of rigid controls.
Ensuring a Smooth Protocol Process into the Future
In the end, it’s essential to focus on the protocol as content rather than as a document. Different recipients will read and use different sections of the document, and it’s highly likely they will cut pieces out of it to copy into their own “manual” for their own part of the process. The full protocol document is one way of presenting your content, but if you keep your text simple, use minimal or simple formatting and ensure consistent wording for technical and medical terms, you will also set up the content to be reused simply, effectively and maybe even automatically.
The protocol development process is a detailed and complex activity that is primed for a shift to digital; however, it’s essential that no corners are cut. Businesses can optimize their current process and position it for future digitization with some very simple activities: capture insightful measures of their current process, apply sensible standards and controls without making them constraints, and ensure they’re creating usable content for various audiences and their varied purposes. By doing so, they can truly claim a successful protocol delivery.
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 2 discussed standardization and control in the protocol development process as a mechanism for improving efficiency.