Community PracticeNCT03953027
Understanding the Impact of Drug Shortages on Oncology Care Delivery
An observational study of Community Practice and Staff, run by University of Rochester NCORP Research Base at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Community Practice, Staff
- What is being tested?
- Survey Administration
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jul 2018to 18 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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)
Who cannot join
- Practices sites without valid CTEP identification (ID)
- Practice sites that do not provide infusional chemotherapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Health Partners Inc
Minneapolis, Minnesota, 55454
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Regions Hospital
Saint Paul, Minnesota, 55101
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, 27104
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- 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
- Being tested
- Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (surveys about drug shortages) | 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). Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs
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.
Measured: Baseline up to 12 months
Change to less effective treatment
Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a "change" for this study. The determination of "less effective" will be made by the primary oncology team. "Less effective" treatments can include those that are not the best options per guidelines through the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and other organizations that establish guidelines for oncology care. Given that the primary oncology team is in charge of the patient's care, they will determine if they think the "change" is "less effective" based on their understanding of the patient's diagnosis and clinical situation.
Measured: Up to 12 months
Change to more toxic treatment
Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a "change" for this study. The practice site staff will verify with the primary oncology team that they perceive this cancer care delivery issue (e.g., change to another drug) to be more toxic than what was intended. Whether the "change" led to a more toxic treatment or regimen will be determined by the primary oncology team. Teams can utilize their pharmacy staff to help determine if the new treatment or regimen has data to support that it would lead to higher toxicity.
Measured: Up to 12 months
Delay in treatment
Assessed with the Drug Shortage Incident Report. 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). Any time there is a change to a treatment regimen due to a drug shortage, the primary oncology team should determine whether or not they perceive this change to be a problem for a patient. When there is a drug shortage that results in a potential issue (e.g., missed dose), the practice site staff will verify with the primary oncology team that they actually perceived this cancer care delivery issue as a problem. The same patient may experience multiple cancer care delivery problems over the course of their treatment. Each of these problems should be reported, de-identified, as separate incidents as they occur.
Measured: Up to 12 months
Medication error/near miss
Assessed with the Drug Shortage Incident Report. When there is a shortage of oncology drugs and there is a change in dose, administration, or drug, there can be medication errors in dose or concentration (e.g., drug was supposed to be diluted, but is not). A near miss is when the primary oncology team identifies a potential medication error but the drug was not administered to the patient. Oncology teams should rely on pharmacy staff to help identify and define medication errors and near misses.
Measured: Up to 12 months
Secondary outcomes (2)
Rate of cancer care delivery problems (CCDPs)
For each quarter and every practice, using the Quarterly Follow-Up Survey, will evaluate the rate of CCDPs as the total number of the reported CCDP incidents (numerator) per number of patients treated (denominator). To estimate the numerator, will sum numbers of reported incidents across all drugs in shortage documented in the Infusional Chemotherapy Incident Report. The total number of patients treated within the practice in the quarter (Quarterly Follow-Up Survey) will represent the denominator. To calculate the overall average estimate of the rate (dependent variable) and its 95% confidence interval, will use a generalized linear mixed model (GLMM) with a Poisson link and independent random effects random effects for sub-affiliates considered within the nested structure of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) members, their affiliates and sub-affiliates.
Measured: Up to 12 months
Strategies practices use
Strategies practices use in response to drug shortages are collected in the Baseline Drug Shortage Survey and the Quarterly Follow-Up Survey. Will calculate the proportion of practices using a particular practice-level response strategy to drug shortages. This proportion will be calculated for each of the following response strategies: stockpiling, increasing staff time, purchasing from secondary markets, changing route of administration (e.g., oral), and sending patients to another institution.
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jul 2018
- Primary completion1 Jun 2025 (estimated)
- Study completion18 Jun 2025 (estimated)
Why it stopped: Study is not human subjects research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester NCORP Research Base
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elaine Hill, University of Rochester
- Investigators
- Elaine Hill, PhD, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953027
- Sponsor's protocol ID
- URCC18004CD
- Other IDs
- NCI-2018-03601, URCC18004CD, URCC-18004CD, URCC-18004CD, UG1CA189961
- Status last verified
- Apr 2024
- First submitted
- 15 May 2019
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Drug Shortages on Oncology Care Delivery
- ClinicalTrials.gov ID
- NCT03953027
- Acronym / sponsor ID
- URCC18004CD
- Conditions
- Community Practice, Staff
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study is not human subjects research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Rochester NCORP Research BaseUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 18 Jun 2025 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (surveys about drug shortages) | – | Other: Survey AdministrationAt 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
- Provide infusional chemotherapy treatment (either inpatient or outpatient)
Key exclusion criteria (2 listed)
- Practices sites without valid CTEP identification (ID)
- Practice sites that do not provide infusional chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationAncillary studies | Other | Health Services Research (surveys about drug shortages) |
Primary outcome
Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs
Time frame: Baseline up to 12 months
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.
Change to less effective treatment
Time frame: Up to 12 months
Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a "change" for this study. The determination of "less effective" will be made by the primary oncology team. "Less effective" treatments can include those that are not the best options per guidelines through the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and other organizations that establish guidelines for oncology care. Given that the primary oncology team is in charge of the patient's care, they will determine if they think the "change" is "less effective" based on their understanding of the patient's diagnosis and clinical situation.
Change to more toxic treatment
Time frame: Up to 12 months
Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a "change" for this study. The practice site staff will verify with the primary oncology team that they perceive this cancer care delivery issue (e.g., change to another drug) to be more toxic than what was intended. Whether the "change" led to a more toxic treatment or regimen will be determined by the primary oncology team. Teams can utilize their pharmacy staff to help determine if the new treatment or regimen has data to support that it would lead to higher toxicity.
Delay in treatment
Time frame: Up to 12 months
Assessed with the Drug Shortage Incident Report. 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). Any time there is a change to a treatment regimen due to a drug shortage, the primary oncology team should determine whether or not they perceive this change to be a problem for a patient. When there is a drug shortage that results in a potential issue (e.g., missed dose), the practice site staff will verify with the primary oncology team that they actually perceived this cancer care delivery issue as a problem. The same patient may experience multiple cancer care delivery problems over the course of their treatment. Each of these problems should be reported, de-identified, as separate incidents as they occur.
Medication error/near miss
Time frame: Up to 12 months
Assessed with the Drug Shortage Incident Report. When there is a shortage of oncology drugs and there is a change in dose, administration, or drug, there can be medication errors in dose or concentration (e.g., drug was supposed to be diluted, but is not). A near miss is when the primary oncology team identifies a potential medication error but the drug was not administered to the patient. Oncology teams should rely on pharmacy staff to help identify and define medication errors and near misses.
2 secondary outcomes
Rate of cancer care delivery problems (CCDPs)
Time frame: Up to 12 months
Strategies practices use
Time frame: Baseline up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Hill, PhD principal investigator
University of Rochester NCORP Research Base
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Practice and Staff, run by University of Rochester NCORP Research Base at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs (time frame: Baseline up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.