Due to the worldwide pandemic, the CDISC European Interchange, originally scheduled to take place in person in Berlin, Germany, was presented completely online. Susan Boquist, Associate Director, Statistical Programming, took advantage of the accessibility and logged in at 3:00 am her time both mornings. Though it may have become an April Fool’s Day to remember, with only a few weeks’ notice, the organizers were able to make the format transformation flawlessly. The conference schedule was consolidated into one track. A networking app was employed to allow for attendees to easily communicate with each other, ask questions of the presenters, and view and vote on the poster presentations. Training and workshops were rescheduled for another time. It was so successful that everyone hopes the organizers will consider adding a virtual option for future conferences.
Coronavirus and COVID-19 issues were underlying themes throughout the presentations. In March, CDISC launched a task force to rapidly develop guidance on standardizing COVID-19 research data with participants from industry, the US Food & Drug Association (FDA), the US National Institutes of Health (NIH), the World Health Organization (WHO), and academia. The working group pulled together as much existing information as possible and used that as the foundation of the guidance. The draft CDISC COVID-19 interim user guide was presented at the conference. It provides examples and guidance on implementing CDISC standards for COVID-19 so that researchers can collect, structure, and analyze data more effectively to amplify the full value of data, drive clinical research forward, and improve global health. Utilizing an accelerated development process, the guide was released shortly after the conference.
Presentations by industry experts encompassed streamlining the clinical trial and approval process. Participants learned that LOINC coding, which allows for clearer classification of laboratory values, is being integrated into FDA requirements. Talks covered the use of EHR data to reduce time and cost, and the use of real world data in place of placebo testing, to save effort and address potential ethical concerns. Detailed guidance submission preparation covered structuring programs, ensuring data traceability, and documenting analysis conduct. The conference ended with discussions by representatives from the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and US FDA, who gave excellent talks and took the time to answer copious questions on multiple topics posed by the international audience.
Somehow, between the tone of the presentations, the lighthearted to serious candor of the entries in the networking app, and the openness of the speakers, attendees felt connected, despite being spread across the globe. We logged out of the conference feeling more hopeful and positive about the future.