Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial...

Area of Science:

• Clinical research operations
• Healthcare management
• Health services research

Background:

• Clinical research program managers face challenges in balancing staff workload with clinical practice.
• Achieving clinical trial accrual goals, data quality, protocol compliance, and budget adherence are key management concerns.
• Accurate workload assessment is crucial for effective resource allocation and staff support.

Purpose of the Study:

• To develop and assess a tool for measuring clinical trial-associated workload.
• To apply objective metrics for documenting research staff work.
• To provide insights for managing clinical research program challenges and balancing workloads.

Main Methods:

• Community-based research programs collected monthly workload data for six months using a web-based tool.
• Data included staff acuity scores and patient encounter numbers.
• Descriptive statistics were used to analyze program characteristics and workload data.

Main Results:

• Fifty-one research programs across 30 states participated in the study.
• Staff acuity scores were highest for patients undergoing treatment compared to those in follow-up.
• Industry-sponsored trials showed higher median staff acuity than other trial types.

Conclusions:

• Trial-specific acuity measurement is a superior indicator of workload compared to patient counts.
• The developed tool demonstrated feasibility and usability in diverse community-based research settings.
• This tool can aid in optimizing staff workload and improving clinical research operations.