There is a great deal of focus on technology solutions in the clinical trial space right now. While I remain cautiously optimistic that some of the emerging technology solutions will help sites operate more efficiently and reach more potential participants, it occurs to me that many, more simple solutions are being overlooked.
I made a recent LinkedIn post regarding sponsors providing “work instructions” for their protocols that was met with some criticism. I wanted to take a moment to elaborate.
As it stands, sites are handed a protocol, 5 or more vendor manuals, eCRF guidelines (if we’re lucky) and perhaps an SIV slide deck. Unfortunately protocols are not written with enough specificity to know exactly what data is being collected (the protocol may ask for “vitals” but in reality want 3 sets of vitals taken 5 minutes apart in different positions). Protocols also make no mention of specific vendors or how these vendors are integrated in to the overall execution of the study. If you need clarification, you may be thumbing through various manuals that are often written very generically and provide no insight in to their role in that specific study.
Essentially, sites are very much left to figure it out on their own – how to create source with limited information, how and when to use each of the various platforms and vendors, the order in which some assessments must be performed, etc. etc.
I believe these issues could be very simply remedied if the studies were better curated by the sponsors via an overarching Manual of Operations or simple work instructions.
There is no reason that these resources would have to interfere with site SOPs or the ability for sites to make their own decisions in how some of these tasks are done, but would simply provide a roadmap for how to carry out the trial in a clean and efficient manner.
Including a simple chronological flow of how visits can/should be performed, which platforms must be utilized and any other material (perhaps some simple “if this then that” scenarios) could make trial execution ridiculously more simple for sites.
If sites are more able to begin a trial with the confidence that they have clear and concise reference material to fall back on, you will see sites more aggressively begin recruitment and far less protocol deviations.
Ultimately, it feels like very little investment from the study sponsors and, potentially, very high returns from their sites.
Once again you hit the nail on the head! I have been saying this exact same thing for years now. It makes no sense why they don’t do this as it would 100% save deviations, increase recruitment, etc. and in turn save them money. Seems like a no -brainer to me.
It’s truly bizarre to me that this is so overlooked. Even CRAs struggle with basic questions regarding protocols so sites are left with absolutely no guidance.
In addition to the benefits you mention, I would imagine the exercise of curating the protocol would force sponsors to recognize gaps in their study and be able to more quickly and efficiently make changes. Again, everyone would win.
Brad, a third party could prepare all of things a site is asking for but the site would have to pay for the services themselves or make a one-off request for reimbursement from the sponsor. A site might see it as a reasonable cost of doing business to gain operational efficiency and make it easier on their staff (CRCs in particular). Now if you had data to show that these ancillary services actually improved site efficiency, recruitment/enrollment and improved quality (ie., reduced deviations and data entry backlogs), then you are starting to speak the sponsor’s language. If, however, they changed none of those things in any significant way, then they would be seen as convenience requests. Sponsors get a lot of convenience requests that hit the budget but have no tangible quality improvement outcome.
Wait, why would a third party need to do this? The sponsor/CRO is the only one who even knows this stuff before the study starts. They have already developed a protocol and contracted with all the vendors. They should know how it all fits together. The burden of figuring it out is already on the sites. I’m saying if the sponsor actually wants a successful trial, they could easily provide some tools.
You’re absolutely right, Brad. No 3rd party should be needed. Sponsors and vendors should not be creating “better reference materials,” but instead deliver tightly orchestrated digital experiences and workflows that take the guess work out of the conduct, allowing sites to focus on clinical care. It’s why I joined ProofPilot.