Alan R Tait, Terri Voepel-Lewis, Brian J Zikmund-Fisher, Angela Fagerlin
Presenting research risks and benefits to parents: does format matter?
Anesthesia and analgesia
many factors contribute developing conducting successful multidata source noninterventional postauthorization safety study nipass submission multiple health authorities studies often large undertakings evaluating sharing lessons learned provide useful insights others considering similar studies discuss challenges key methodological organizational factors led delivery successful postmarketing requirement pmrpass program investigating risk cardiovascular cancer events among users mirabegron oral medication treatment overactive bladder provide context share learnings including sections research program collaboration scientific transparency organizational approach mitigation uncertainty around potential delays validity study outcomes selection data sources optimizing patient numbers choice comparator groups enhancing precision estimates associations potential confounding generalizability study findings interpretation results large pmrpass program longterm commitment parties benefited effective coordinating center extensive scientific interactions across research partners scientific advisory board study sponsor health authorities delivered useful learnings related design organization multidata source nipass