DIA: Driving Insights to Action Unknown

Good Publication Practice (GPP) experts explain the authorship algorithm designed to weigh each author's contribution relative to other authors' contributions in a study, and to define appropriate ways to establish the authorship byline.

Accumulus Synergy CEO Francisco Nogueira shares expectations for the outcomes of a post-approval changes pilot led by Roche which utilizes the Accumulus platform and follows WHO principles of good regulatory reliance practices.  

Listen to former DIA Board President Minnie Baylor-Henry’s special message to DIA members as part of DIA’s 60th Anniversary celebration in 2024.

A few years ago, 8-year-old Autumn noticed a lump on the side of her neck as she was preparing for bed one night. That quiet night opened a new chapter not only in Autumn’s life but in the life of her entire family: Autumn had leukemia. In this interview, Autumn shares the story of her treatment and recovery as a girl who had not yet turned 11. Her experience was also captured in a documentary. When asked to share her advice to healthcare professionals and researchers as a pediatric oncology patient, Autumn explained: “Every patient is a different case, has a different body, and knows about their body. No matter how amazing you are at the job, keep in mind what children have to say instead of what you already know.”

In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. “What's really changed and what will persist after COVID? First, I think regulators have become a bit more comfortable in dealing with uncertainty. Uncertainty is the biggest challenge rather than benefit-risk,” he explains. “International regulatory collaboration became the basis of working together on these new products: We exchanged information on policies, on how the clinical data was developing, on the real-world performance of these drugs and vaccines, and on safety and post-approval requirements. These are going to persist.”

In part two of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research and care with DIA GAM 2023 Patient Engagement track chair Pujita Vaidya. “This advent and acceleration of artificial intelligence (which should be augmented intelligence) and digital biomarkers should not replace the physician-patient relationship but enhance it,” Stacy explains. “Lastly: If you want sustainable patient insights, don't only ask a patient, but invest in and hire patients as internal subject matter experts and full-time employees of your organization.” Listen to part 1.