Date of Award

Fall 2024

Project Type

Clinical Doctorate

College or School

CHHS

Department

Nursing

Program or Major

Doctor of Nursing Practice

Degree Name

Other

First Advisor

Dr. Courtney Coffey

Second Advisor

Patty Tribulski

Abstract

Abstract

BACKGROUND: Pharmacovigilance (PV) Sciences include activities related to safety surveillance of pharmaceutical products, and is critical for developing safe and effective medications, vaccines and medical devices. Safety monitoring starts with preclinical research and continues through clinical trial and post marketing phases. PV scientists ensure patient safety during clinical trials through regular review and analysis of safety data. Regulations have become increasingly complex, leading to inadequately defined methods for reviewing large clinical trial safety datasets. Inconsistent safety data review (SDR) practices can result in delayed detection of adverse drug reactions (ADRs) or safety signals.

METHODS: This quality improvement project used the Plan Do Study Act (PDSA) model to develop a Safety Data Review Handbook and standardize safety surveillance of patients in clinical trials. Feedback from PV scientists, along with current pharmacovigilance regulations, guided its creation. A mixed methods analysis was used to evaluate attitudes toward current processes and the perceived value of using a standardized approach. The Handbook included SDR guidance, work instructions, review checklists, and a training program.

INTERVENTION: An anonymous survey was distributed to PV scientists working in the pharmaceutical industry to evaluate PV scientists’ experience level, current safety data review practices, satisfaction with the existing processes, and interest in adopting standardized SDR guidance. Focus groups and interviews were utilized to assess the needs and challenges faced by PV scientists. A needs assessment was conducted to demonstrate value of the project. The QI project team piloted the SDR handbook to a small group of PV scientists and incorporated user feedback at each iteration of the Handbook development.

RESULTS: A total of 63% of scientists who were asked to complete the survey responded. All of the scientists reported that they conducted periodic safety reviews, and most had a strategy for analysis. Survey results revealed moderate discontent with the current SDR process. There was a notable difference between satisfaction with current practice and the perceived utility of a standardized SDR approach. Most of the scientists strongly agreed that standardizing process would be beneficial, and all of the scientists agreed that added consistency would add value to periodic safety data reviews during clinical trials. Additionally, focus group discussions highlighted the desire for additional SDR training along with a structured guidance document.

CONCLUSION: These findings reveal that while current SDR practice is functional, there is room for improvement. PV scientists support standardized SDR strategies to promote clinical trial safety surveillance consistency. Providing a Safety Data Review Handbook that includes guidance documents and analysis tools improves the uniformity of safety monitoring, potentially improving ADR detection and patient safety.

Download

Share

COinS