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What is Clinical Research?

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The UCD Cancer Trials Cluster is involved in many types of research, not just clinical trials. We have managed and facilitated clinical trials, translational research, allied health research, as well as observational studies. All of our research aims to better understand, treat, and care for people with cancer.

There are numerous ways of categorising these studies, but one approach is to determine whether they are interventional or non-interventional. 

This section will begin by describing the difference between interventional and non-interventional research, before delving into what a clinical trial is. 

The UCD Cancer Trials Cluster would like to thank the Irish Cancer Society for allowing us to adapt their content in the creation of this page.

Interventional Research

In research, an intervention means doing something specific to people, like giving them a new medicine or trying a different therapy. Scientists study the effects of these interventions to see if they help or have any side effects. 

Clinical trials are considered interventional research and might involve the testing of new medications, radiation therapy procedures, new medical devices, or new surgical procedures. 

Other types of interventional research includes, for example, the development of new psychological therapies, exercise interventions, changes in diet, or changes in how people are cared for within the clinical setting. 

Non-Interventional

Non-interventional research is when researchers study people or diseases by collecting information without providing any new treatments or interventions. Instead, researchers observe and gather data from individuals in their regular daily lives, medical records, or biological samples. This type of research helps us see patterns and trends to better understand the disease or patient experience. 

Non-interventional research can often lead to interventional research. For example, in pre-clinical/translational studies, researchers may examine whether a cancer cell taken from a tissue sample might respond to a potential new drug. Similarly, psychologists might look to interview people about their experiences of cancer in order to develop a new psychological treatment. 

Clinical Trials

A clinical trial is a research study in humans with the aim of answering specific questions about a new medical treatment, for example drugs, new therapies, or new ways of using existing treatments. Clinical trials are used to determine whether new treatments are safe and effective. All the standard medical treatments that we use today have been tested in clinical trials.

Clinical trials for cancer aim to find new and better therapies and help to improve outcomes for people with cancer.

Some trials may examine drugs used, how the drugs affect people, or how they affect a person's cancer. The drugs being tested may be brand new treatments or existing drugs used in a new combination.

Other trials don't use drugs at all. Rather, they might, for example, focus on improving surgical procedures, increasing quality of life, or using exercise to improve physical function. 

In other words, a clinical trial in cancer is any systematic and controlled way of testing a new intervention. 

Clinical Trial Development

Basic Science
Scientific exploration that can reveal fundamental mechanisms of biology, disease, or behaviour.
Translational Research
Preclinical research connects the basic science with medicine by using known discoveries to develop new ways of treating or managing disease.
Clinical Trial: Phase 1
Small-scale test to assess safety, dosage, and side effects in a small group of healthy volunteers or patients.
Clinical Trial: Phase 2
Expands to a larger group to evaluate effectiveness and further assess safety while monitoring side effects and optimal dosage.
Clinical Trial: Phase 3
Compares new treatment with existing standard of care in a larger population to confirm effectiveness, monitor side effects, and collect more data.
Clinical Trial: Phase 4
Post-approval stage where treatment is monitored in a larger population to gather additional information on long-term benefits, risks, and best use in real-world settings.

Trial Eligibility

Not all trials are suitable for all patients, even if they have the same cancer type.

Trials often need patients with similar criteria, including: age, sex, stage of cancer, previous treatments, and other medical conditions. For this reason, trials have very strict rules. This means that some people can be included in the trial, but some are not suitable and so will not be able to take part.

You may also need a medical examination and additional tests to check if you can take part in the trial.

Safety of Trials

When a drug is being used in a clinical trial it has already been carefully tested to make sure it is safe to use in a clinical trial, though there may be serious side effects. The consent form you are asked to read and sign if you want to join the trial will explain expected side effects or problems. Your doctor will also discuss any risks with you.

The doctors and nurses who run the trial check throughout the trial that new treatments and their side effects are safe.

Your trial doctor and nurse will check you very closely throughout the trial. If the new treatment is not working as well as the standard medical treatment, you will be moved back on to the standard medical treatment.

Trial Regulation & Approval

Every clinical trial involving patients in Ireland must be approved by the Health Products Regulatory Authority (HPRA) and by a recognised ethics committee:

  • The HPRA makes sure that the trial meets Irish, EU and international standards for clinical research.
  • The ethics committee ensures that the rights and wellbeing of the patients who are taking part in the trial are looked after. For new medicines, the Department of Health supervises this process.

If the trial application is approved by the HPRA and the ethics committee, the researchers can begin the trial. Once the trial has started it will be checked regularly to make sure the regulations are being followed and everything is being done correctly. The HPRA can also make an official inspection of the trial at any time to make sure it is being carried out properly, with patient safety in mind. 

Making a Decision

If you are suitable for a trial, it can be hard to decide about whether to take part. Here are some things to think about:

Pros:

  • The trial treatment might be better than the standard treatment.
  • Your doctor may find out more about your cancer due to extra tests only available on clinical trials.
  • You may be helping to improve cancer treatment for future patients.
  • Your clinical trial team will organise all your hospital appointments as the trial recommends.
  • You will be closely monitored by a team of doctors and trial nurses.

Cons:

  • The trial treatment may be as good as the standard treatment, but it might not be better. 
  • You might have some side-effects after taking the trial treatment.
  • You might have to make more visits to the hospital than patients who are on the standard treatment.
  • If you are on a randomised trial using a new drug you may still only receive the standard treatment.

Asking lots of questions can help you think about the pros and cons.  It is a good idea to:

  1. Write down any questions you have before you go to your appointment.
  2. Bring someone with you, if possible - they can help you to remember what the doctor or nurse says. 
  3. Bring a notebook and write down the answers to your questions.
  4. If you don't understand something, ask the doctor or nurse to explain again.

Informed Consent

Giving consent means that you understand the trial and agree to take part. You cannot be part of a clinical trial if you have not given your permission. If you want to take part, you will be asked to read a consent form. 

The consent form explains: 

  • Why the trial is being run,
  • What it hopes to achieve 
  • What the possible side-effects and risks are 
  • Why you have been invited to take part.

It is important that you understand everything about the trial before you agree to take part. This is called informed consent. If you want to take part, you will fill in and sign the consent form. You can change your mind about taking part, even if you have signed the consent form or started your trial treatment.

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Contact the UCD Cancer Trials Cluster

UCD Clinical Research Centre, St Vincent's University Hospital, Elm Park, Dublin 4
E: cancertrials@ucd.ie