Clinical Trials
Do you want to contribute to on-going medical research? Are you interested in helping to evaluate new treatments or tests to improve patient outcomes?
St. Vincent’s University Hospital is at the forefront of cutting edge clinical research in Ireland and internationally. As a large academic teaching hospital, we strive to advance medical care for all of our patients by supporting high-quality clinical research opportunities – in conjunction with our partners in UCD – which will ultimately deliver more effective outcomes for our patients.
The hospital runs clinical trials in a number of different disease areas and is always interested in hearing from volunteers who are keen to get involved.
What is a clinical trial?
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions.
What are the benefits of taking part?
- You have an opportunity to gain access to a promising new treatment
- If the trial treatment is proven to be better than the standard treatment, you will be one of the first patients to receive it.
- You will be closely monitored by a team of doctors and nurses.
- You may be helping others by contributing to medical research
St.Vincent’s University Hospital is a research-intensive academic teaching hospital and all our clinical trials are closely monitored by our team of doctors and nurses.
Want to take part? Or simply find out more?
Make sure you talk to your doctor or consultant if you want to get involved.
FAQ
ELIGIBILITY
There are certain requirements which must be met to be eligible to participate in a clinical trial. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone for participating are called “exclusion criteria” These requirements are based on such factors as age, gender, the type and stage of the disease, previous and current treatments and other medical conditions.
In clinical studies, investigational drugs are often compared with approved placebo (substances that are made to resemble drugs but do not contain an active drug) to assess safety and effectiveness. Clinical study participants may be assigned to take:
- Investigational drugs
- Approved drugs
- Placebo
- A combination of these
INFORMED CONSENT
If you are eligible and decide to participate in a Clinical Trial, a Patient Information Leaflet and an Informed Consent Form will be presented to you. This document includes information about the clinical trial and what you can expect as a participant, as well as potential benefits and possible risks associated with the clinical trial.
You should take your time and read carefully through the Patient Information Leaflet and the Informed Consent Form. When you are satisfied that all of your questions have been answered by the doctor, you will be asked to sign the Informed Consent Form.
POTENTIAL BENEFITS AND RISKS
BENEFITS
- You have an opportunity to gain access to a promising new treatment
- If the trial treatment is proven to be better than the standard treatment, you will be one of the first patients to receive it.
- You will be closely monitored by a team of doctors and nurses.
- You may be helping others by contributing to medical research
Clinical trials also help to find out if:
- Treatments are safe.
- Treatments have any side effects.
- Treatments are effective at treating a certain disease.
- New treatments are better than the standard available treatments.
WHAT QUESTIONS SHOULD I ASK?
- What is the purpose of the trial?
- What is the trial called?
- What treatment will I be receiving?
- What is the difference between the trial treatment and standard treatment?
- What are the side effects of the trial treatment?
- What are the benefits of the trial treatment?
- What are the risks of taking part in the trial?
- How many patients are taking part in this trial?
- Will I be reimbursed for other expenses?
- Will the trial cost me money?
- What treatment will I have if I do not want to take part in the trial?
- What will happen if I want to discontinue the trial treatment?
- When will the trial results be available?
- How is my data being protected?
TRIAL SAFETY AND REGULATION
Every clinical trial must be approved by the Irish Regulatory Authority known as the Health Products Regulatory Authority (HPRA) and also by a recognised Research Ethics Committee (REC) prior to enrolling any patient into a trial. The HPRA and REC will review the trial to ensure the following:
- Protection of patients’ rights
- Adequate patient safety and monitoring
- The benefits outweigh the risks
- Ensure scientific integrity
- Ensure quality and compliance to standards of good clinical practice.
In Ireland, all medicines must successfully complete numerous rounds of clinical trials before they are granted a license to be openly prescribed by a doctor, so clinical trials are important to allow new effective medicines to reach patients.