DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies

Active, not recruiting

• Conditions: Participation Rate, Patient; Patient Participation

• Registration Number: NCT06486402
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Primary Completion: 2024-03-01
• Study First Submitted: 2024-03-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participation rate	5 year	Number of patients participating in a clinical trial

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-holland, Netherlands