Can Digital Protocols Improve Feasibility?


Trial feasibility sometimes feels like a progressive game of bait and switch. In other words, early versions of a protocol offered by a sponsor, may evolve several times over the stages of feasibility and site initiation, with each stage of evolution resulting in a version of a study that’s more complex than the last. Finally, when the rubber meets the road and it’s time to start the trial, sites remain confused about execution and fumble through the first several patients, risking patient safety and scientific integrity. This is far too common a scenario for an industry dealing in such high stakes.

Sponsors attribute some of this continuous evolution to ongoing, unforeseeable decisions and last-minute changes. Yet most would agree that the final protocol and accompanying documents should tell the whole story for a site. But they don't. During Site Initiation Visits (SIV), the protocol takes on yet a whole new look, making those early feasibility assessments, final document versions and even training, obsolete. One of the most unfortunate impacts of the current framework is that sites have often negotiated a contract and site payment structure based on incomplete understanding of what it really takes to conduct the study.  And so when payments are misaligned with study conduct, sites and sponsors will need to re-negotiate these budgets or else decide to part ways, either by formally withdrawing from the study or just simply quiet quitting.

Digital protocols can offer better transparency into what it takes to conduct a protocol on a variety of levels, relieving many of the pain points as described above. In short, digital protocols offer a WYSIWYG (what you see is what you get) level of trust in feasibility, translating all the way down to execution, to ensure sites and sponsors are in lock step with expectations of budget, resources and activities required to conduct a study.  

 A digital protocol can break down every protocol related task and the relevant metadata to provide a clear, 360-degree picture of what is required to conduct a study: effort tracking, cost, wait times, technology use, patient reminders, prep time and more! And while much of this may not be known in the very early stages of design – and certainly may not be relevant even from the standpoint of the site early on – a digital protocol also enables real time modeling and on demand sharing of protocol designs that can profoundly impact the operational demand on the site. 

Certainly, the idea of communicating day by day updates to protocol designs may hurt more than help the cause. But if nothing else, at the end stages of the study startup phase, sites are deserving of a fully integrated digital workflow to follow. This will greatly improve the experience of both sites and patients, while ensuring protocols are being conducted with a high level of rigor from the get-go. Remember, an interventional drug research protocol is already a highly complex experiment. The current model force sites to further experiment with their understanding of the protocol with the first 5 patients they enroll. Digital Protocols are here today for ensure flawless execution!  Come hear from sites and sponsors on this topic at SCOPE, 9am Thursday, Feb 9, 2023 

Joseph Kim


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