Derk Arts, MD PhD’s Post

This also assumes that the ePRO option presented to participants actually functions… We have a large phase 3 vaccine study and the vendor’s app is literally impossible for either participants or our staff to figure out. And of course there’s no online/url option, so patients have to be given a device and come to the site. Sponsors and vendors can do better, e.g., ask sites what will work when designing a study (and not faculty, the actual staff!). We (sites) want to make it easier on our participants, but a half-baked solution with bells and whistles isn’t that.

If there are futures that reduce or eliminate the need for patients to enroll in trials, then those are futures we should all get behind. Whether sponsor, CRO or site owner, it would be immoral and unethical to enroll a single patient in a trial when there emerge validated and regulatory-ready technology-based alternatives. If those models make me and my peers in research obsolete, then we simply did not keep pace and need to move on. Fortunately there has been regulatory support for data-driven alternatives to reduce the number of patients in some control arms and that should be celebrated rather than feared.

Why would anyone prefer paper to a well-designed ePRO? Dan Sfera

This is an import point of divergence: how much are we responsible for our own inertia? Traditionally, paper has been comfortable for many sites--to this day--and will be for some time to come, especially in resource-constrained settings. However, the rate-limiting step in a process is the least kinetic one. For this reason, I am never opposed to sponsor companies providing better technical capabilities to sites even if it comes off as being paternalistic. If you want to put in 5G networks across the globe, then as a company you may have to foot the technology bill to build that capacity in some places so that your network operates at 5G everywhere.* ____ *Any resemblance to any geopolitical scenario is purely by accident.

I think it’s also helpful to separate the issue of meeting the needs of the trial for data/scientific purposes and the issue of access to potentially therapeutic clinical trials for potential participants, especially where there are poor options within standard of care (e.g., oncology, CNS, etc.). The issues overlap but the needs and solutions might be different.

Aside from the very important element of including more diverse patients in clinical trials, and opening access to convenient, remote collection of some data, when appropriate to the study, I remain concerned with the integrity of paper-based source data. So I’d truly like to understand better, @dansfera, why paper remains preferable and what the industry needs to do, to make ePRO preferable for sites. What is the primary burden that you see as outweighing the benefits of reduced data entry and easier data monitoring visits? Is it specifically usability for the patients and/or sites or simply too many different systems to deal with? Something else?

Why would paper-based PROs exclude a large proportion of clinical trial populations? Is the post or courier not working anymore?😉

collaborations between all cro that want to do this themselves and increase their bottom lines while not keeping these things in house?

ePRO is pretty much ubiquitous at this point and they're fine. Is there any evidence that ePRO usage has increased data quality, enrollment numbers, diversity or inclusivity? I can't think of any instances in which ePRO vs paper has been the dealbreaker from a participation standpoint - distance notwithstanding. Is there an article that accompanies this graphic? Sorry if I missed it.

In my opinion the problem here is execution and the one-size-fits all approach, with ePRO versus PRO, o some instances one will be better in others not so much. Yes we need to make trials better for all ! Derk Arts, MD PhD , Dan Sfera, Brad Hightower we need a podcast on this topic, looking at e/PRO form the perspective of various stakeholders identify challenges and possible solutions.