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What is the study about?
Clinical trials are crucial for advancing biomedical knowledge and improving patient care, but access remains highly limited.
Participation and retention do not only depend on medical eligibility, but are also shaped by social, cultural, economic, and psychological barriers.
- These barriers contribute to the underrepresentation of diverse patient groups, limiting the relevance and generalizability of research outcomes.
- For patients who have exhausted standard treatments, clinical trials may be the only remaining option for care.
Understanding the barriers that hinder patients from participating and staying in trials and how to overcome them is, therefore, crucial to enhance clinical research and improve patient care.
Although concerns related to diversity, equity and inclusion in clinical trials have only started to be addressed in recent years, there is already an emerging body of literature that addresses this issue. However, being based mostly in the United States, most of these studies focus on racial and ethnic disparities and render invisible other factors such as gender, sexuality, mental health, economic status, literacy or medical mistrust.
This project will explore broader social determinants that hinder participation in oncology trials in Ireland to understand what diversity and inclusion means in this specific context.
Aim and Objectives
The aim of this project is to enhance clinical research and improve patient care for a diverse population by boosting the representation of all patient demographics in clinical trials.
Objectives:
- Identify, analyse and compare the demographics of patients that are diagnosed with cancer at St. Vincent’s University Hospital and those that participate and stay in CCT at St Vincent’s UCD Cancer Centre & UCD Clinical Research Centre.
- Explore and analyse the social, cultural, economic and psychological barriers that hinder participation in cancer clinical trials, in particular at St Vincent’s UCD Cancer Centre & UCD Clinical Research Centre.
- Bring together the different perspectives and lived experience of the various stakeholders involved in clinical trials, i.e., people affected by cancer, healthcare professionals, clinical trial unit staff and sponsors; and promote mutual understanding among them of what it means and takes to access, participate, conduct and deliver a clinical trial.
- Recommend a plan of action to improve representation in cancer clinical trials at St Vincent’s UCD Cancer Centre & UCD Clinical Research Centre, that could be applicable to other centres.
Methodology
1) Literature Review of existing quantitative and qualitative studies on social determinants and access and retention in clinical trials.
2) Quantitative analysis of the socio demographic characteristics of patients.
3) Ethnographic Study
- Observation of the clinical trial life cycle.
- Informal and formal interviews.
- Patients, Health Care Professionals, Researchers and Clinical Trial Unit Staff.
4) Photovoice
- Capture the lived experience and the perspective of the various stakeholders involved in oncology clinical trials.
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Who is involved in this project? and who to contact for more information?
Principal Investigator:
Prof. Michaela Higgins, Consultant Medical Oncologist, Clinical Professor, St. Vincent's University Hospital and University College of Dublin.
Co-investigators:
Prof. Janice Walshe, Consultant Medical Oncologist, St. Vincent's University Hospital.
Prof. Patricia Fox, Assistant Professor, School of Nursing, Midwifery and Health Systems, University College of Dublin.
Prof. Eilish McAulifee, Full Professor, , School of Nursing, Midwifery and Health Systems, University College of Dublin.
Prof. Susi Geiger, Full Professor of Markets, Organisations and Society, School of Business, University College of Dublin,
Dr. Christopher Crockford, Cancer Trials Programme Manager, Cancer Research Programme Office, University College of Dublin.
Mr. Mohamed Ahmed, Cancer Trials Programme Manager, Cancer Research Programme Office, University College of Dublin.
Dr. Isabel Briz, Public and Patient Involvement and Research Officer, Cancer Research Programme Office, University College of Dublin.
Contact Person:
Dr. Isabel Briz, (opens in a new window)isabel.brizhernandez@ucd.ie