RationalizationNCT04314336
The Economic Impact of Clinical Pharmacist Involvement in the Public Procurement for Medicines and in the Drug and Therapeutics Committee
An observational study of Rationalization, run by Bjelovar General Hospital at 1 site in Croatia.
Trial summary
The investigators have performed cost-minimisation analysis and compared the expenses based on the plan for public procurement (without clinical pharmacist involvement) for drugs with the results of public procurement based on the revised plan for public procurement by the clinical pharmacist. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Rationalization
- What is being tested?
- Public procurement and Drug and Therapeutics Committee
- How many people
- 10,000 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Aug 2019to 1 Jun 2020
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inhospital patients, all patients receiving any medicine during their stay in the hospital within 1 year period.
Who may be able to join
- All patients in the hospital (inhospital patients)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Economic Impact of Clinical Pharmacist Involvement in the Public Procurement for Medicines and in the Work of the Drug and Therapeutics Committee, Single-centre, Cost-minimisation Study
The investigators have performed cost-minimisation analysis and compared the expenses based on the plan for public procurement (without clinical pharmacist involvement) for drugs with the results of public procurement based on the revised plan for public procurement by the clinical pharmacist. The plan for public procurements was based on the 1 year quantity for each medicine used by the hospital in the previous year, based on the latest deliverable prices at the time of extracting the data to workbook for MS Excel program (ver. 2002, Microsoft, Redmond, WA, USA).
The investigators have performed cost-minimisation analysis and compared the expenses for all received requests for medicines to the drug and therapeutics committee (DTC) for a decision in the 1 year period, before and after involvement of clinical pharmacist in the committee work. The expenses were based on approval decisions in the 1 year period for approval time period. The denial decisions were also calculated and reported. The denial period calculated in rationalisation of expenses were based on 1 year treatment period.
- Conditions
- Rationalization
- Being tested
- Public procurement, Drug and Therapeutics Committee
- Keywords
- Rationalization, Clinical Pharmacist, Public Procurement for Medicines, Drug and Therapeutics Committee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public procurementDrug
Cost minimisation study through public procurement
Drug and Therapeutics CommitteeDrug
Cost minimisation analysis of results of the drug and therapeutics committee before and after clinical pharmacist involvement
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing prices of medicines
Reduce prices of medicines in percentage, since different countries and hospitals have various budgets and medicine prices
Measured: 1 year
Secondary outcomes (1)
Rationalization of expenses
Rationalization of expenses through rquests for medicines sent to Drug and Therapeutics Committee
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Aug 2019
- Primary completion1 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RationalizationStudies 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
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bjelovar General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugen Javor, Bjelovar General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314336
- Sponsor's protocol ID
- 1520192020
- Status last verified
- Dec 2020
- First submitted
- 17 Mar 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Economic Impact of Clinical Pharmacist Involvement in the Public Procurement for Medicines and in the Work of the Drug and Therapeutics Committee, Single-centre, Cost-minimisation Study
- ClinicalTrials.gov ID
- NCT04314336
- Acronym / sponsor ID
- 1520192020
- Conditions
- Rationalization
- Keywords
- Rationalization, Clinical Pharmacist, Public Procurement for Medicines, Drug and Therapeutics Committee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Bjelovar General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 Mar 2020 (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.
The investigators have performed cost-minimisation analysis and compared the expenses based on the plan for public procurement (without clinical pharmacist involvement) for drugs with the results of public procurement based on the revised plan for public procurement by the clinical pharmacist. The plan for public procurements was based on the 1 year quantity for each medicine used by the hospital in the previous year, based on the latest deliverable prices at the time of extracting the data to workbook for MS Excel program (ver. 2002, Microsoft, Redmond, WA, USA).
The investigators have performed cost-minimisation analysis and compared the expenses for all received requests for medicines to the drug and therapeutics committee (DTC) for a decision in the 1 year period, before and after involvement of clinical pharmacist in the committee work. The expenses were based on approval decisions in the 1 year period for approval time period. The denial decisions were also calculated and reported. The denial period calculated in rationalisation of expenses were based on 1 year treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inhospital patients, all patients receiving any medicine during their stay in the hospital within 1 year period.
Key inclusion criteria (1 listed)
- All patients in the hospital (inhospital patients)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Public procurementCost minimisation study through public procurement | Drug | – |
| Drug and Therapeutics CommitteeCost minimisation analysis of results of the drug and therapeutics committee before and after clinical pharmacist involvement | Drug | – |
Primary outcome
Reducing prices of medicines
Time frame: 1 year
Reduce prices of medicines in percentage, since different countries and hospitals have various budgets and medicine prices
1 secondary outcome
Rationalization of expenses
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Rationalization
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Pediatric Intensive Care Unit, Pediatric Immuno-hematology Department
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rationalization, run by Bjelovar General Hospital at 1 site in Croatia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reducing prices of medicines (time frame: 1 year). 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 17 Dec 2020.