Clinical Trials

What is a clinical trial?

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to assess  if a new treatment is more effective and /or has less harmful side effects than the current standard treatment.

Why participate in a clinical trial?

There are many reasons why people choose to join a clinical trial. Some join a trial because the treatments they have tried for their health problem did not work. Others participate because there is no treatment for their health problem. By being part of a clinical trial, participants may find out about new treatments before they are widely available. Some studies are designed for, or include, people who are healthy but want to help find ways to prevent a disease, such as one that may be common in their family.

Many people report that participating in a clinical trial is a way to play a more active role in their own health care. Other people feel that they want to help researchers learn more about certain health problems. Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. And, your contribution can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants – young and old.

How can I get involved?

Patients can take part in clinical studies covering a wide range of medical diseases, conditions, and rare disorders affecting both children and adults. Healthy volunteers who seek to advance knowledge about causes, progress, and treatment of disease may also participate in clinical studies. They provide important medical information to researchers by helping them compare how healthy people differ medically from those who have a specific disease.

If you would like to get involved in a clinical trial, please see the clinical trials currently recruiting participants here: www.rotunda.ie/research-department/clinical-trials

Questions can be directed to research@rotunda.ie

What are the benefits and risks of participating in a clinical trial?

  • Access to a treatment that isn’t available yet.This treatment may be more effective or have fewer side effects than the treatments that are currently available.
  • Regular and careful attention from skilled health care professional . Because of this close monitoring, any side effects you might have are noticed and dealt with immediately.
  • Contributing to research that may save lives in the future.The treatments we have today are available because large numbers of women opted to participate in clinical trials to test them.
  • The feeling that you’re taking an active role in your care and health.Deciding to participate in a clinical trial can make some people feel as if they have more control over their situation, which can lead to a more positive outlook and better quality of life.

How do I agree to participate in a clinical trial?

Informed consent is a process used by researchers to provide trial participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it.  Participation in a clinical trial is completely voluntary and refusal to participate will not affect your care in any way.

What is informed consent? 

The researcher will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test. This process of understanding the risks and benefits of treatment is known as informed consent. Informed consent is based on the moral and legal premise of patient autonomy: You as the patient have the right to make decisions about your own health and medical conditions. You must give your voluntary, informed consent for treatment and for most medical tests and procedures

There are 4 components of informed consent: you must have the capacity (or ability) to make the decision; the medical provider must disclose information on the treatment, test, or procedure in question, including the expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur; you must comprehend the relevant information; you must voluntarily grant consent, without coercion or duress.

What should people consider before participating in a trial?

The risks and benefits are different for everyone. Each clinical trial has different risks and benefits. And because all clinical trial participants are different, they will experience these risks and benefits in different ways. For example, one participant may experience a side effect that another participant does not.

Since clinical trials are experiments, the exact risks and benefits can be difficult to predict. But researchers only move forward with clinical trials when they are optimistic about the potential benefits and believe the risks for participants are acceptable. In addition, an Research Ethics Committee must review and approve the research protocol, , before researchers can enroll participants. Researchers are required to inform participants about potential risks and benefits before they enroll in a clinical trial. This discussion takes place during what’s called the Informed Consent process, which helps participants understand what’s involved so that they can make the decision that’s right for them.

How do I know if I am eligible?

All clinical trials have rules about who can and cannot participate. Factors that allow someone to participate in a clinical trial are Inclusion Criteria. Those that disqualify someone from participating are called Exclusion Criteria. These criteria are based on things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Inclusion and Exclusion Criteria are developed with much thought and consideration. They are necessary to prove whether medicines or treatments will work or not in a specific group of people and to make sure the right participants enter the trial and stay safe. These criteria are applied to all potential participants equally before they start the study.

Clinical trials take place in different settings. Clinical trials can be conducted in a variety of places, including hospitals, universities, doctors’ offices, and community clinics all around the world. Some clinical trial facilities are fully dedicated to research, while other facilities house both research and healthcare delivery. Similarly, some medical professionals who conduct clinical trials devote all of their time to research, while other professionals split their time between research and healthcare delivery.

Can a participant leave a trial after is has begun?

Participants can drop out of clinical trials at any time. Participants can drop out of a clinical trial even after they have agreed to participate. And they do not need to give a reason. No matter what stage of a clinical trial, participants have the right to change their mind. If a participant decides to stop participating, the Principle Investigator will remove them from the trial in a way that is safe for the participant.