Clinical Trials Explained
Clinical Trial
A clinical trial is a research study that involves human volunteers. It aims to find new and better treatments for people with diseases. These treatments may include:
- Drugs
- Cells and other biological products (e.g. vaccines, hormone replacements)
- Surgical procedures
- Devices (e.g. pacemaker, inhaler)
- Behavioural treatments
- Preventive care
- New ways of using known treatments e.g. using a known treatment for a different disease with similar symptoms.
Carefully designed, reviewed and completed
Carefully conducted clinical trials are used to determine whether specific healthcare interventions – such as those listed above – are safe and effective. Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.
Clinical Trial Phases
New therapies or procedures are tested first in the laboratory and in animal studies. This early-stage research can take many years before a potential new therapy is found. Those with the most promising possibilities are moved into human clinical trials.
There are 4 phases of clinical trials (phase I – IV) which help decision makers decide whether to approve a new therapy or not. During each trial phase, more and more information is gathered about the potential treatment, its risks and how well it may or may not work, along with aspects related to quality of life.
- Phase I: New treatments are tested for the first time in a small group of people to evaluate a safe dosage range and identify side effects
- Phase II: Safe treatments from phase 1 are tested in a larger group to monitor for any adverse effects
- Phase III: Safe treatments from phase 2 are tested on even larger populations and in different regions and countries
- Phase IV: After the intervention is approved researchers may study long-term risks, benefits and side effects during day-to-day use in the population
Participating in a clinical trial
People who take part in a clinical trial are called participants, and participating in a clinical study may help to discover new treatments. It’s very important that participants of different ages, sex, ethnicities and backgrounds take part to ensure that the research will benefit as many people as possible.
To learn more about participating in a clinical trial in Ireland, check out the FAQ section of the HRB-National Clinical Trials Office.
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