Pulmonary Hypertension Unit

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Trial Participant Information

What is a clinical trial?

A clinical trial is a clinical research study that examines a new medical treatment or a new and innovative way of using an existing treatment.

The aim of the trial is to explore if this new medication, new dose of treatment or method of drug delivery can benefit patients further than existing treatment can. Carefully conducted clinical trials are the fastest and safest way to find treatments that improve people’s health by perhaps improving exercise capacity, ease of drug delivery, quality of life and survival rates.

A person is recruited in to a clinical trial by meeting certain criteria, based on their current clinical stability, suitability for the trial, and their desire to be involved in the trial. Informed consent is obtained from the participant by the Consultant before any involvement can be had in the trial. A copy of the consent and patient information is provided to the participant for their records.

What Happens During a Clinical Trial?

The team will check the participant’s general health at the beginning of the trial, ensure they meet the required criteria for entry in to the trial, provide information on the trial and what specific instructions are necessary for taking part in the trial. A participant in a clinical trial will be reviewed in the clinic usually every 4 weeks by the research team ( PH Consultant and Nurse Specialist) and clinical stability and progress monitored.

Trial visits are very similar to the normal clinic visit where bloods are taken, weight, blood pressure, heart rate and oxygen levels are recorded. A six minute walk is also performed and recorded. The participant is examined by the PH Consultant or his designated registrar, and any problems with general health or PH symptoms are addressed. Response to the trial medication is also closely recorded.

Some clinical trials involve more tests and doctor visits than others, depending on the design of the trial.

What is a Protocol?

A protocol is the study plan on which the clinical trial is based. The plan is carefully designed to protect the health of the participants as well as to answer specific research questions about ways to improve or advance progress in a particular condition or disease. A protocol sets out very strict criteria about what type of people can be involved in the clinical trial. It also states what investigations are necessary at each stage of the trial, what details should be recorded, how often the participant should be reviewed during the trial, how to take study medication, and how frequently and how long the study will last. During a clinical trial, participants following a protocol and are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of the treatment.

What are the Risks of being in a Clinical Trial?

Some medications used in clinical trials can have annoying or unpleasant side effects. In some cases, the treatment may not be effective for the participant.

The protocol may require more of the participant’s time and attention than a standard treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are the Benefits of being in a Clinical Trial?

Participants in clinical trials play a more active role in their own health care

They have an opportunity to gain access to new and innovative treatments before they are otherwise available. Participants get expert care at a leading health care facility, typically a specialist centre for that particular disease and they are ultimately contributing to medical research and helping to advance progress in a particular disease area.

Who pays for Clinical Trials?

Clinical trials are sponsored or funded typically by medical institutions and more often by pharmaceutical companies.

Who can take part in a Clinical Trial?

All clinical trials have rules and regulations about who can and cannot be involved in the clinical trial. This is an important principle of medical research, as it helps researchers to determine who will best benefit from this study medication, and it will help them to get answers about the study topic or question.

The rules that allow someone to participate in a clinical trial are called inclusion criteria and those that keep someone out of a trial are called exclusion criteria. The inclusion and exclusion criteria are based on such factors as a person’s age, gender, the kind of disease he or she has , how advanced the disease is, what treatments he or she is currently on, and whether that person has other medical problems.

It is important to understand that inclusion and exclusion criteria are not used to reject people personally. They are used to identify those participants who will most benefit from involvement in the trial.

What is Informed Consent?

Informed consent is obtained before a participant is allowed to commence in a clinical trial. It is obtained by the consultant after the participant is provided with full information about all details of the trial and study medication. If the participant does not speak English well, a translator will be organised. The informed consent document also explains the potential risks and benefits of the trial , who to contact if problems arise and full details on study visits and medication dosing and times of administration.

Participants also will get information about how things are going during the trial. The participant then decides whether or not to sign the document. Informed consent is not a contract, and a participant can decide to pull out of the trial if so desired.

How is the participant’s safety protected?

The ethical and legal codes of conduct that govern medical practice also apply to clinical trials.

In addition, clinical research trials are regulated by international guidelines on how clinical trials should be run, to ensure the safety of all participants.

The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial goes forward, researchers report the results of the trial at scientific meetings, to medical journals and various government agencies. The participant’s identity is always protected and no names are disclosed when in the trial. Every clinical trial in Ireland must be approved and monitored by the Irish Medicines Board (IMB) and all centres conducting clinical trials are subject to IMB audit, to safeguard participant’s safety.

Can  participants pull out of a clinical trial after it has started?

Yes.  Participants can leave a clinical trial at any time.

If they leave the trial, they must let the research team know, and tell them why they are leaving the study. A follow up study visit will be required after withdrawal from the study to ensure that the participant is doing ok.

What if I am thinking of being involved in a trial?

If a participant is considering involvement in a trial and is meeting the study team (consultant and nurse specialist), it is advisable to write down their questions and concerns.

Always bring a friend or family member along as support. This is also useful as they too can hear the answers and can reiterate them at a later stage, or perhaps remember answers that the potential participant cannot remember.

What are the Different Types of Clinical Trials?

Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for people with a chronic illness.

What is a Control or Control Group?

A control is the standard that the research team uses to compare and evaluate the results of the experiments done in the trial. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

What is a Placebo?

A placebo is a pill, liquid, or powder that looks like medicine but has no medicine in it and has no effect on people. It is commonly called a “sugar pill.” In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. The participants in the control group may receive a placebo instead of an active drug or treatment.

What are Side Effects and Adverse Reactions?

Side effects are any undesired actions or effects of a drug or treatment. Drugs used in clinical trials must be evaluated for both immediate and long-term side effects.