Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment

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

Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.

The first utterance happened on day two of the SCOPE Summit during the feasibility and site selection track. I had the talk on my schedule for weeks: “Human Trial Navigation, Data Reciprocity, and the Future of Trial Access,” with experts from CSL Behring, Evernorth Health Services, DTRA, GSK, and the University of Modena and Reggio Emilia. In it, they covered a lot of ground, so much so that I can’t recount it all here. Instead, I’m focusing on their conversation around patient data return.

Valerie Balosso, GSK senior director, therapeutic lead for infectious diseases, and her peers volleyed commentary about returning data at scale — including, but not limited to, individual, aggregate study, imaging, and genetic data. Everyone agreed on its importance, but it was Balosso who intimated that importance alone is not enough for some pharma decision makers. They want to know about the return on investment. Why should they allot time and money to give data back to patients?

(A simple answer might be that it’s the patient’s data, after all, but we’ll leave that aside for now.)

The next morning, Biogen and Teckro teamed up for a presentation on returning individual patient data. Interestingly, Biogen’s Head Clinical Trial Accelerator & Senior Director Jane Twitchen didn’t mention what the company stood to gain by making patient data readily available. Rather, they focused on the strategy and execution of a program, which they’re tweaking for future iterations. They also mentioned survey results from PHUSE’s Patient Data Return Project, which reported that seven of the 14 responding pharma/biotech companies currently return data to clinical trial participants.

The next day, this time in the recruitment and engagement track, a panel of diversity devotees talked through the best ways to embrace a diversity strategy, including first appealing to internal stakeholders before working externally.

The catch, said Merck Senior Director, Health Literacy Strategy and Innovation Laurie Myers, is convincing decision makers of the value. As with returning patient data, conducting diverse clinical trials demands an ROI. It’s “the elephant in the room,” she said.

Both speakers, with not an eye roll or an ounce of shade, matter-of-factly aired what many believe to be true: that pharma needs a reason beyond “doing the right thing.” It’s lamentable, but not all that surprising.

Now, you could go down the path of crunching numbers to convince decision makers why both efforts make money sense. But I think the payoff is much simpler to determine than that.

Days ago, Clinical Leader published the first article of an ongoing series by CISCRP, which shares findings of its annual Perceptions & Insights survey. In it, they reveal that only 18% of more than 12,800 respondents from around the world trust pharmaceutical companies “a lot.” That’s way behind research centers/clinics and healthcare providers, government research organizations, and government regulatory agencies (such as the FDA).

And there it is: The ROI is better public trust.

“It’s the right thing to do” is the sentiment of the folks who support the return of patient data and the inclusion of diverse patient populations in research. And when someone does right by us, it creates this sense that we’re on the same page, that we have the same values.

A routine and trivial example of this is when I attempted to return a makeup product that just didn’t suit me. The company made amends by refunding my money but not requiring me to return the product. That meant no scavenging the recycling bin for the original box, no trekking to the post office during lunch, and no long lines to contend with. That goodwill gesture — the recognition that my time is valuable — makes me see this company in such a good light. I trust them, and I’ll be back to try other products.

In that same way, the public and clinical trial participants might be more inclined to see pharmaceutical companies more favorably if given similar treatment. We all want to be seen, understood, and appreciated. When we are, we’re more agreeable and willing to trust.

So, while it’s realistic to number crunch and to determine material ROIs, trust is the currency pharma should be counting.