UCB is in San Diego for DIA-Global 2019 this week. Ahead of her presentation, Liz Roberts, our Global Public Policy Lead, shares insights from the industry perspective on clinical trial disclosure and data transparency, and what UCB is doing to keep patients at the center of our work in this space. For more, see Liz speak today, June 25, 2019 at 2:00 p.m. in room 4 (session #260).

“As a biopharmaceutical industry, it is important that we continue to challenge ourselves to find new ways to disclose clinical trial results that are meaningful and valuable. It is important to go beyond what’s required by regulatory agencies to be publicly disclosed and consider the ultimate consumers of the information – trial participants, patients, caregivers, advocates, and the public.

“Oftentimes, regulatory agencies require reporting in various formats. Sponsors can also publish additional voluntary disclosures. With so many sources of information available, it is best practice to approach reporting from a holistic and global view, asking ourselves: Is the information we’re sharing complete, accurate, and consistent? And importantly, is it understandable to the intended audience? This last point is critical, and trial result summaries (typically called ‘lay summaries’) that are in a non-technical format can be helpful to both patients and the public.

“As such, at UCB, we’re working to consider clinical trials through the lens of patients and develop result summaries that are not only accurate and unbiased, but also easy to understand and consider the perspective of the audiences reading them. To accomplish this, UCB engages a panel that includes a patient living with the disease, a caregiver, a member of the public, a medical expert, and a plain language editor when creating trial results summaries. The insights gained from these representatives help us to adapt, refine, and clarify trial results so they are understandable for most audiences.

“We believe making our summaries available to patients is one way show respect for their dedicated time, resources, and participation in our trials. In addition to encouraging patients to discuss any questions they have with their doctor, we also provide details of a company contact in case they have additional questions related to the summary.

“This week at DIA-Global 2019, I look forward to the opportunity to engage, share, and learn from other life science professionals as we work to find new ways to progress as an industry to better share information with patients participating in clinical trials.”