Annual SCOPE Summit Serves Up A Similar But Satisfying Menu

By Abby Proch, executive editor of guest columns, Clinical Leader

Two SCOPEs of clinical research innovation, please.

That is, I’ve attended two SCOPE Summits in my time here at Clinical Leader. Last year, everything was new and exciting. This year, the choices were mostly the same and somewhat less tantalizing.  Can it be that I’ve grown bored of all the flavors (i.e. themes) after just two years?

It’s easy, as most of the long-time industry folks know, to find yourself nodding along as opposed to aha-ing at every turn. But even though the themes and perennial complaints persist, there are still many relevant tidbits to savor and reflect upon.

As an example, Joan Chambers of Tufts CSDD shared data that was both “same old” and eye-opening. For me, a particular stat illuminated two industry-wide problems: too-long and/or complicated informed consent forms and increasingly complex trial demands.

Chambers reported that — after reviewing a study ICF — 54% of those who did not choose to enroll in the study made the decision based on the burden of participating (Mapping the Evolving Global Landscape of Investigative Site Models). It’s disheartening, to say the least, that industry is still not consistently designing trials that strike a balance for all parties involved. (Although, there has been a glimmer of that happening, as I discovered when chatting with Biohaven’s Jason T. Lerner, MD a few weeks ago.)

Chambers also shared data about remote and virtual solution adoption pre- and post-pandemic. Across telemedicine, wearables, home visits, home therapeutics delivery, and remote monitoring, uptake was slim before COVID-19. In March 2021, surveyed companies increasingly used these solutions. Notably, the use of telemedicine rose from 22% to 57%, home visits jumped from 37% to 61%, and home delivery skyrocketed from 20% to 64%. A little more than a year later, in June 2022, when many pandemic protective measures faded and “normal” life resumed, their use dropped. Though these companies didn’t revert to pre-pandemic use, there was a marked decrease — for instance, home visits dropped from 61% to 32% and remote monitoring dropped from 70% to 55%.

Not within the scope of the report, understandably so, is why those solutions weren’t used as frequently. Were these fixes just good enough for the moment but not sustainable moving forward? And why? Was it the cost, the logistics, the training, the data integrity? Those answers might not come easy, however. In another session, Tufts CSDD Data Scientist Abigail Dirks shared that only 36% of the literature published since 2022 has contained hard data (case reports, surveys, etc.) on DCTs. The majority of content out there is opinion and conjecture.

Anecdotally, and albeit an n of 1, Brad Hightower of Hightower Clinical, which has several sites in Oklahoma and Arkansas, indicated his experience with DCT elements thus far can be approximated as meh. He’s open to them but has seen a “mixed bag” of results as far as user experience with the patients and site staff. One thing’s for sure, though, the panel of “eCOA BOYD: Exploring the Pros and Cons” agreed: bring-your-own-device (BYOD) for eCOA is great, in theory. While promising to save costs over provisioning devices, reduce e-waste, and be a familiar option for patients, BYOD is only as good as the tech it’s running and the tech support that’s helping site staff and patients with the inevitable issues it experiences. (Note to those developing apps and their behind-the-scenes technologies: “I’ll pass that on to our IT department” is not a fix when patients are already at the site and the clock’s ticking on their PTO, if they  have it.)

And while I’m dolling out tips (don’t kill the messenger), here’s one for sponsors and CROs that I picked up during a panel session: If you “promote” a trial coordinator to a role in your organization, please give them the grace of proper notification and a transition period to get their position filled and obligations delegated. They’re having a tough time with staffing as it is. Oh, and “Let me check and get back to you” repeated by a site monitor during a PSV is not a helpful response to questions about the protocol.

In addition to the tasty tidbits dolled out by panelists and presenters, there was plenty of delightful interaction with fellow attendees. Read: The networking is crème de la cookies ‘n cream. For me, that’s equally as, if not more, satisfying than the talks I attended. Much of my work is done digitally, and most of the people I’ve “met” in my role have been over email and, if we’re lucky, Zoom calls that we both show up to and aren’t interrupted by internet drops. How lovely it was to put real faces to email addresses, accounts, and AI-created avatars. And even more lovely that the people I connected with are just as pleased to see me.

Despite some sameness, it’s also encouraging to see that these themes persist, that they are not given up on, that the industry is always looking for solutions, never backing away from a challenge or allowing itself to be distracted by the flavor of the month.