Clinical trial · Observational
Understanding the Impact of Drug Shortages on Oncology Care Delivery
NCT03953027CI-TRIAL-00088150withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is not human subjects research.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Community Practice | — | UNRESOLVED | — |
| Staff | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Health Services Research (surveys about drug shortages)
- description
- At baseline, practice sites complete a Baseline Drug Shortage Survey and Pharmacy Baseline Survey; Drug Shortage Incident Reports are completed in real time as cancer care delivery problems occur; and the Quarterly Follow-Up Survey Number Treated Report every 3 months for one year (4 total).
- interventionNames
- Other: Survey Administration
Primary outcomes (5)
- measure
- Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs
- timeFrame
- Baseline up to 12 months
- description
- Each incident is defined by the drug in shortage and by each cancer care delivery decision (e.g., whenever a recommended treatment plan is developed). All incidents are collected de-identified and aggregated to the practice site. For each drug in shortage during the year (4 quarters) of observation, will determine the number of practices reporting a care delivery problem due to each drug during any quarter and total number of practices treating patients with the drug during any quarter. Will calculate the proportion of affected practices among practices treating patients with the drug as the ratio of these two numbers. Will calculate mean, median, range and evaluate the shape of the distribution of drug specific estimates.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Be a primary affiliate or sub-affiliate of an NCORP community site or minority underserved (M/U) community site that is affiliated with the University of Rochester Cancer Center (URCC) NCORP Research Base * Practice sites must have a valid Cancer Therapy Evaluation Program (CTEP) identification number * Practice sites may or may not share a pharmacy * Provide infusional chemotherapy treatment (either inpatient or outpatient) Exclusion Criteria: * Practices sites without valid CTEP identification (ID) * Practice sites that do not provide infusional chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.