FormulariesNCT03218189
Differences Between Essential Medicines Lists in 135 Countries and Model List of Essential Medicines
An observational study of Formularies, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The World Health Organization (WHO) has developed a model list of more than 400 medicines and recommends that each country adapt the list to its own circumstances. More than 100 countries have developed essential medicines lists. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Formularies
- What is being tested?
- Country characteristics
- How many people
- 137 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2017to 4 Apr 2019
- 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: Countries that have an essential medicines list are included in the study
Who may be able to join
- Countries that have an essential medicines list, and Canada
Who cannot join
- countries that do not have an essential medicines list that is available online
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences Between Essential Medicines Lists in 135 Countries and the World Health Organization's Model List of Essential Medicines
The World Health Organization (WHO) has developed a model list of more than 400 medicines and recommends that each country adapt the list to its own circumstances. More than 100 countries have developed essential medicines lists.
Some countries have essential medicines lists that are very similar to the WHO's model list and other countries have lists that are very different from the WHO's model list. Differences between the WHO list and country lists could be explained by features of the country including population demographics, disease prevalence, Gross Domestic Product (GDP), and healthcare system organization. Other factors such as the influence of particular individuals or organizations may also explain differences between countries.
The purpose of this project is to compare the essential medicines lists developed by countries with the WHO's model list and to identify attributes of countries that are associated with differences from the WHO list. Predictors such as region, population, life expectancy, infant mortality rate, GDP per capita, health expenditure per capita, inequality, and the corruption perception index will be considered.
Read the detailed description
Statistical analysis plan for objective 3 (relationship between the total number of differences and country features)
Plots will be generated to show the relationships between variables. Correlation coefficients will be calculated where appropriate. Two separate multivariate models will be fit to the data for outcomes 2a and 2b [continuous, between 1 and 500]. A similar model will be fit the total number of differences. The analytical method will be determined by the data and may be liner regression.
Predictors:
Region-Categorical (6)
Population-Continuous
Life expectancy-Continuous
Infant mortality rate-Continuous
GDP per capita-Continuous
Health expenditure per capita
Inequality-Continuous
Corruption Perception Index-Continuous
- Conditions
- Formularies
- Being tested
- Country characteristics
- Keywords
- Essential medicines lists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Country characteristicsOther
Observational study of country characteristics
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of differences between the WHO model list of essential medicines and the essential medicines list in each country
The total number of differences between the WHO model list of essential medicines and the essential medicines list in each country is comprised of:
- number of WHO model list medicines not on country list including the number of substitutions within class (i.e. a medicine on WHO list not on country's list but a similar agent in the same class is on the country's list); and the
- number of medicines on the country list but not on the WHO model list.
Measured: 1 year
Secondary outcomes (2)
Medications that are on the WHO list but not on the country list
Measured: 1 year
Medications that are on the country list but not on the WHO list
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 posted14 Jul 2017
- Study start5 Jul 2017
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FormulariesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218189
- Sponsor's protocol ID
- 14-308
- Status last verified
- Sep 2019
- First submitted
- 12 Jul 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the time of publication, we will publicly post a table with the country characteristics and the outcomes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences Between Essential Medicines Lists in 135 Countries and the World Health Organization's Model List of Essential Medicines
- ClinicalTrials.gov ID
- NCT03218189
- Acronym / sponsor ID
- 14-308
- Conditions
- Formularies
- Keywords
- Essential medicines lists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 14 Jul 2017 (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 World Health Organization (WHO) has developed a model list of more than 400 medicines and recommends that each country adapt the list to its own circumstances. More than 100 countries have developed essential medicines lists.
Some countries have essential medicines lists that are very similar to the WHO's model list and other countries have lists that are very different from the WHO's model list. Differences between the WHO list and country lists could be explained by features of the country including population demographics, disease prevalence, Gross Domestic Product (GDP), and healthcare system organization. Other factors such as the influence of particular individuals or organizations may also explain differences between countries.
The purpose of this project is to compare the essential medicines lists developed by countries with the WHO's model list and to identify attributes of countries that are associated with differences from the WHO list. Predictors such as region, population, life expectancy, infant mortality rate, GDP per capita, health expenditure per capita, inequality, and the corruption perception index will be considered.
Detailed description
Statistical analysis plan for objective 3 (relationship between the total number of differences and country features)
Plots will be generated to show the relationships between variables. Correlation coefficients will be calculated where appropriate. Two separate multivariate models will be fit to the data for outcomes 2a and 2b [continuous, between 1 and 500]. A similar model will be fit the total number of differences. The analytical method will be determined by the data and may be liner regression.
Predictors:
Region-Categorical (6)
Population-Continuous
Life expectancy-Continuous
Infant mortality rate-Continuous
GDP per capita-Continuous
Health expenditure per capita
Inequality-Continuous
Corruption Perception Index-Continuous
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Countries that have an essential medicines list are included in the study
Key inclusion criteria (1 listed)
- Countries that have an essential medicines list, and Canada
Key exclusion criteria (1 listed)
- countries that do not have an essential medicines list that is available online
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 |
|---|---|---|
| Country characteristicsObservational study of country characteristics | Other | – |
Primary outcome
Total number of differences between the WHO model list of essential medicines and the essential medicines list in each country
Time frame: 1 year
The total number of differences between the WHO model list of essential medicines and the essential medicines list in each country is comprised of: 1. number of WHO model list medicines not on country list including the number of substitutions within class (i.e. a medicine on WHO list not on country's list but a similar agent in the same class is on the country's list); and the 2. number of medicines on the country list but not on the WHO model list.
2 secondary outcomes
Medications that are on the WHO list but not on the country list
Time frame: 1 year
Medications that are on the country list but not on the WHO list
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 6 Sep 2019.
- Individual participant dataSharing planned: Yes. At the time of publication, we will publicly post a table with the country characteristics and the outcomes
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 Formularies, run by Unity Health Toronto at 1 site in Canada.
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 6 Sep 2019. 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 Canada. 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?
Total number of differences between the WHO model list of essential medicines and the essential medicines list in each country (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 6 Sep 2019.