Dr. Su Golder, associate professor and senior research fellow in the Department of Health Sciences at the University of York, has dedicated a significant portion of her career to improving the reporting of adverse events in clinical research. In this episode, she speaks with host Deborah Borfitz about why adverse events are vital to address but often difficult to ascertain for any given therapeutic intervention.
Golder talks about the strategic ways data can be manipulated—often leading to underreporting or misleading reporting—and the preferred guidelines that help researchers relay accurate information to clinicians and patients. She also discusses why data from randomized controlled trials are not always the best indicator of adverse advents in the real world and why social media provides valuable insights into why patients discontinue drug usage even when symptoms are considered minor. She says, “If something stops a patient from taking [a drug], then it doesn’t matter how effective [that drug] is. So [patient experience] is the most important thing.”
Links from this episode:
Clinical Research News
University of York
Adverse Event Reporting May Need A Total Redo
Medicines & Healthcare products Regulatory Agency Yellow Card reporting
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
PRISMA harms checklist: improving harms reporting in systematic reviews
Consolidated Standards of Reporting Trials (CONSORT)
OpenTrials: towards a collaborative open database of all available information on all clinical trials
Cochrane Adverse Effects Methods Group
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.