Data Collection in Clinical Trials: The Role of the Nurse-data_collection_in_clinical_trials_the_role_of_the_nurse

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Video Summary

The presentation explains how pediatric oncology nurses support clinical trials, especially through accurate data collection and protocol adherence. It distinguishes academic trials, which advance scientific knowledge and are often more flexible, from industry-sponsored registrational trials, which are designed to support FDA approval and are more rigorous. The speakers emphasize why FDA approval matters: it improves safety confidence, insurance coverage, prescribing guidance, and patient access. They stress that trial data must be timely, accurate, reliable, and reproducible, because missing or incorrect information can lead to censoring patients, weakening study results, and even study failure. Nurses play a key role in documenting assessments, administering study drugs correctly, reporting adverse events, tracking protocol deviations, educating families, and confirming eligibility before consent. Best practices include regular protocol training, using checklists, and maintaining strong communication with the research team and families.

Keywords

pediatric oncology nursing

clinical trials

protocol adherence

FDA approval

data collection

adverse event reporting