The 9 day protocol and the future of clinical trial documents

by Oct 5, 2021

The 9 day protocol and the future of clinical trial documents

The life sciences industry has responded to the critical pressures of the Covid-19 pandemic and has made safe and effective vaccines available at record speeds. One remarkable example of acceleration can be found within the clinical research information on the MHRA website (the MHRA is the UK Regulator) spotlighting the RECOVERY trial, which aims to identify effective treatments for patients who have been hospitalized with Covid-19:
“In just 9 days the RECOVERY trial protocol was written and approved, and the first participants were recruited”.

For anyone who has direct experience of the current methods of writing and approving clinical trial protocols, this is a truly jaw-dropping statement. The full package of regulatory submission documents, including the protocol, is posted publicly on the RECOVERY website, but there is nothing at all remarkable about the documentation. The protocol and associated submission documents are traditional, text based PDF documents. Although there are significant innovations in the way RECOVERY has been set up to collect and manage data, it seems when it comes to the protocol writing and approval steps, the speed was not enabled by technological or process innovation but simply because everyone involved was united by the goal of completing the process at the maximum speed. So perhaps what it tells us is that under near-perfect conditions, where all bottlenecks and inefficiencies are removed, there is only 9 days’ actual work involved in creating and approving a protocol.

Of course, there are lots of caveats to that statement, including the fact that RECOVERY has an adaptive design, so the relatively simple first stage of the trial approved in version 1.0 of the protocol has already been amended and submitted for re-approval 18 times in the 18 months since that nine day initial approval period in March 2020. But it’s probably safe to assume that without a pandemic driving the same single-minded focus, a post-pandemic, traditionally written protocol document for a new trial is going to revert to pre-pandemic timelines because the process has not fundamentally changed. Now we have seen that a process can be completed in 9 days, we should not simply accept that things will return to the “old normal” once the pandemic is finally behind us.

Today’s clinical trial documentation processes still look very much like traditional, paper-based documentation processes, where paper has simply been replaced by word processing solutions without any further optimization of process or technology. This is not a situation that is unique to clinical trials, as highlighted by recent Forrester Research on “The Future of Documents”, where they note that “most document authoring habits have not really changed in over 30 years”.

Consider the clinical trial protocol in the context of the “mismatch between the needs of document authors and document receivers” noted by Forrester. Highly skilled and highly qualified scientists spend significant amounts of time addressing document formatting and style, which in many situations is a legacy of authoring conventions rather than a necessity. All participants in the process lose time based on limited or inefficient options for real-time collaboration and review using traditional word processing tools. The protocol is the blueprint for the clinical trial and multiple consumers of the content spend a significant amount of time identifying and extracting the information they need to kick off the next part of the process or to set up the systems that will be used to execute the trial – or in Forrester terms “heroic efforts… are needed to get usable data out of documents”. Imagine the opportunities for downstream automation if protocol “documents” were instead created as described by Forrester as “assembled sets of objects, with context and meaning wrapped around them (i.e., metadata)”.

At Nurocor, we are not just imagining the possibilities, we are delivering on a vision to significantly transform clinical research from a paper-based world to a digital protocol driven collaboration platform. You can read more about that in our blog post on the Nurocor Roadmap to a Digital Data Flow, and with every new release of the Nurocor Clinical Platform our vision is rapidly becoming a reality. Our latest platform release at the beginning of August already enables standards driven study design, allowing the creation of structured protocol content and a full Schedule of Activities (SOA). We have enabled downstream automation of study level EDC build from the protocol elements and SOA and delivered a full round-trip workflow to integrate data standards change requests when creating the SOA. The standards-based protocol elements include Objectives and Endpoints and will soon be expanded to include library driven Inclusion and Exclusion criteria. Alongside the SOA, these are already “objects with context and meaning wrapped around them” which we will be able to assemble in to a full digital protocol, with integrated authoring, as our roadmap progresses. The same standards enabled design process with integrated authoring will allow us to tackle any template-based document in the clinical trial process, with an electronic Stats Analysis Plan, including a TFL builder, already taking shape.

In the Nurocor Clinical Platform, the “Future of Documents” for clinical trials is happening now. We do not believe that the speed of protocol authoring and approval for the RECOVERY trial should be seen as a one-off, instead we take the 9 day timeline as a benchmark for what can be achieved and accept the challenge of making that the “new normal” for the protocols of the future.