For those who attended the SCDM Live Global Conference, the futuristic style of the virtual meeting and the theme (Future Now: v.2.021) did not disappoint. The conference last week broke attendance records with 1650 attendees from around the world. There were ample opportunities to hear from a broad range of experts representing industry, academia, technology providers, consultants, CROs, and health authorities.
As noted in our pre-conference blog, in the Regulatory Town Hall, representatives from FDA, MHRA, and Danish Medicines Agency provided updates on internal agency initiatives and collaborations. Of note, Lisbeth Bregnhoj (Danish Medicines Agency) reminded attendees that the draft guidance on computerized systems and electronic data in clinical trials is now available for public consultation. She encouraged everyone to review the draft and provide comments by December 17, 2021. Ms. Lisbeth also mentioned an initiative that evolved from a discussion at the 2019 SCDM where interested parties began discussing AI in clinical trials. It is a joint initiative between SCDM, eClinical Forum, and regulators (FDA and EU GCP IWG/EMA).
Jean Mulinde from FDA CDER noted the final Bioresearch Monitoring (BIMO) guidance was released this year along with a technical conformance guide. She also highlighted progress on the PHUSE Biomonitoring Project which focused on creating a BIMO Data Review Guide Template that was recently presented a the PHUSE Conference.
Finally, Laurie Muldowney from FDA CDER spoke about the impact of COVID-19 on agency operations as site closures, absenteeism, and supply chain issues impacted protocol mandated visits as well as inspections. Laurie spoke about the continued focus on trial integrity and data quality. Almost 80 of guidances were released under the temporary authority of the public health emergency.
Data quality and the evolution of data management toward data science were recurring themes throughout the conference. There were multiple presentations about decentralized trials (DCTs). Most suggested that the hybrid DCT will continue to be the prevailing model for most clinical trials. Decentralized elements such as telehealth have made trial participation more convenient for trial participants. They will most likely continue to be popular options where possible.
One of the most compelling sessions at the conference was “A Jab of Hope – Data Management Enabling the Pathway to a COVID-19 Vaccine.” In this session, representatives from AstraZeneca, J&J, and Pfizer spoke about their experiences over the last 18 months. They talked about how they formed their teams, how they operated, the challenges of global teams working remotely, what worked and what didn’t.
Interestingly, leaders from these teams met with each other throughout the pandemic to share lessons learned. Their shared experiences led them to frank and open discussions about how they were operating and how they might improve internal processes.
Heightened transparency, agile processes, and the cultural aspects of high-performing teams were themes that appeared throughout the presentations.
Heightened transparency was required, which meant some junior team members had to learn to present information to senior management effectively. The burden of consistent transparency was noted, and a single point of contact was recommended to address management and other external teams. The heightened transparency also meant daily data reviews. It led to the creation of multiple dashboards that reflected the status of the trial.
Agile processes were used across all teams. Daily stand-ups (huddles) helped teams navigate new situations and remove hurdles. Many traditional serial processes were assessed for risk and run in parallel to shorten timelines. Artificial intelligence (AI) and machine learning (ML) were used to speed up data processing. Quality and integrity of the trial and data needed to be a priority throughout all these process shifts.
Presenters also commented on the cultural aspects of team performance. Throughout the pandemic, team members were dealing with remote work, lockdowns, fear, and loss. One team created a “no finger-pointing” rule to skip the blame and go directly to solving the problem. Leaders considered the soft skills needed to be successful in such a high-pressure environment. Empathy and compassion grew significantly as teams spent enormous amounts of time together. They paid attention to the well-being of their team members. The session delivered a powerful reminder of the critical role of R&D teams around the globe and how much can be achieved with a focus on a common goal.
If you missed us at SCDM, please contact us to learn about our approach to the rapidly evolving clinical trials industry, and how our team is supporting research organizations meet the demands of new and emerging models, including decentralized and hybrid study designs.