Participation Rate, PatientDISPARITYNCT06486402
DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies
An observational study of Participation Rate, Patient and Patient Participation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Participation Rate, Patient, Patient Participation
- What is being tested?
- participation rate
- How many people
- 5,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Mar 2023to 1 Dec 2024
- 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
- Child, Adult, Older adult
Study population: The study population consisted of various clinical trials, both falling within and outside the scope of the WMO, involving adult patients undergoing various types of medical surgeries. Importantly, only studies that did not preclude women beforehand and obtained consent before participation were included in the analysis.
Who may be able to join
- various clinical trials, both falling within and outside the scope of the Medical Research Involving Human Subjects Act
- adult patients undergoing various types of medical surgeries.
Who cannot join
- . studies which excluded or did not equally approach women beforehand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Evaluation of Characteristics of Participants in Clinical
The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery.
To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.
- Conditions
- Participation Rate, Patient, Patient Participation
- Being tested
- participation rate
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participation rateOther
participation rate
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Number of patients participating in a clinical trial
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participation Rate, PatientStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486402
- Sponsor's protocol ID
- W23_111 # 23.136
- Acronym
- DISPARITY
- Status last verified
- Jul 2024
- First submitted
- 26 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Evaluation of Characteristics of Participants in Clinical
- ClinicalTrials.gov ID
- NCT06486402
- Acronym / sponsor ID
- DISPARITY / W23_111 # 23.136
- Conditions
- Participation Rate, Patient, Patient Participation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Jul 2024 (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 aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery.
To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of various clinical trials, both falling within and outside the scope of the WMO, involving adult patients undergoing various types of medical surgeries. Importantly, only studies that did not preclude women beforehand and obtained consent before participation were included in the analysis.
Key inclusion criteria (2 listed)
- various clinical trials, both falling within and outside the scope of the Medical Research Involving Human Subjects Act
- adult patients undergoing various types of medical surgeries.
Key exclusion criteria (1 listed)
- . studies which excluded or did not equally approach women beforehand
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 |
|---|---|---|
| participation rateparticipation rate | Other | – |
Primary outcome
Participation rate
Time frame: 5 year
Number of patients participating in a clinical trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Participation Rate, Patient and Patient Participation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 Netherlands. 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?
Results are not available in the source record.
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?
Participation rate (time frame: 5 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 3 Jul 2024.