Sexy Science, Clinical Ops as a Business, Data Custodians
By Allison Proffitt
October 31, 2023 | “I want to encourage you when you get frustrated, or when you get elbowed out by somebody talking ‘sexy science’, to not let it get to you,” said Deidre BeVard to the clinical ops executives gathered earlier this month at SCOPE Europe in Barcelona. “Keep the relentless pursuit of what you’re doing. There’s people all over this building and throughout our industry who want to help you do that,” continued the senior VP for R&D Strategic Operations at CSL. “Stand shoulder to shoulder with those colleagues.”
The SCOPE community is certainly full of those colleagues. The European event convened more than 500 clinical ops executives and representatives from sponsors, CROs, and vendors for two days of programming covering feasibility and site selection; enrollment planning and participant recruitment; risk-based quality management; and clinical data technology.
BeVard’s opening keynote challenged the community to view clinical ops as a growth driver for business and inspired them to fight the good fight.
“This role is often underestimated, underrecognized… and it is really hard work,” BeVard said, calling for a round of applause for the clin ops members of the SCOPE audience. “If you do your jobs really, really well, nobody knows it.” Yet she emphasized that clinical trial operations is business critical to R&D. It may not be the “sexy science” or the exciting, final regulatory push, she said, but it is the critical step between.
BeVard set out a challenge for clinical ops executives in the room: view your trials as a business—with all the challenges, excitement, and reward that comes with the idea. Every trial operational plan is a business plan. Clinical ops teams must marshal resources to deliver their products on time in a supersaturated market. Each business, “must run at multiple, disparate organizations—otherwise known as sites—over which you have zero authority,” and they likely have multiple layers of overhead and administration. You have to rely on those businesses to recruit the participants you need, she said, who have zero incentive to join your study or stay in it and are likely at the most vulnerable time in their lives.
It’s a high risk, high reward enterprise, she conceded, but, “What you’re doing is going to perhaps save a life, extend a life, or improve a life.”
With this inspiring—but sobering—vision, data takes center stage, driving successful clinical operations. Adana Ibrahim, VP Digital Strategy and Change Management at NovoNordisk, highlighted that the needed improvements are now rarely technical or infrastructure development. It’s a people problem.
“The barrier for achieving the impact of innovation is 70% due to people,” Ibrahim said, quoting a recent study. “Seventy percent is because of us! Because we refuse to change, or we don’t have the right ways of working, or we don’t have the right connectivities between departments.”
Ibrahim has convened a group of pharma companies to troubleshoot digital strategy, and they agreed: culture change is needed. They recommended sticking to FAIR principles—data that are findable, accessible, interoperable and reusable, as a ground truth—and motivating communities and organizations as data custodians from there.
“A lot of us tried to implement FAIR in our organizations… to democratize not just the data, but the ways of working,” she said. “We’ve got to get people excited, and we’ve got to get people thinking. My job now is not what it was ten years ago. My job now is to be a custodian of data, and I am responsible.”
It’s a weighty responsibility, but as BeVard reminded us in her opening keynote: it is a worthy calling. This is a business delivering hope.