NCT03953027

Understanding the Impact of Drug Shortages on Oncology Care Delivery

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This trial studies the impact of drug shortages on oncology care delivery. Gathering information about cancer drug shortages over time may help researchers improve access to drugs during times of shortages.

Detailed description

PRIMARY OBJECTIVES: I. To prospectively estimate the proportion of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs. SECONDARY OBJECTIVES: I. To prospectively estimate the rate of cancer care delivery problems attributable to a drug shortage of infusional therapeutic oncology drugs for patient populations treated with: a) all cancer drugs, b) all cancer drugs in shortage, and c) each individual cancer drug in shortage. II. To assess strategies practices used during drug shortages (e.g., manage costs, stockpile, hire staff). TERTIARY OBJECTIVES: I. To assess practice factors (e.g., case mix, size, practice type) associated with the likelihood that a practice reports cancer care delivery problems. II. To describe how practice-level strategies in response to drug shortages vary by practice characteristics. III. To describe the possible effects on clinical trials (e.g., unable to enroll a patient or changing to an alternative treatment). IV. To characterize cancer care delivery problems attributable to a shortage of supportive care agents. V. To characterize cancer care delivery problems attributable to a shortage of oral anti-cancer agents. OUTLINE: Practice sites complete a Baseline Drug Shortage Survey, Drug Shortage Incident Reports in real time as cancer care delivery problems occur, and the Quarterly Follow-Up Survey every 3 months for one year (4 total).

Conditions

• Community Practice
• Staff

Interventions

Type	Name	Description
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2018-07-01
• Primary completion: 2025-06-01
• Completion: 2025-06-18
• First posted: 2019-05-16
• Last updated: 2025-04-04

Locations

6 sites across 1 country: United States