Patients
Choosing to participate in a clinical trial is an important personal decision. The following sections provide detailed information about clinical trials. In addition it is often helpful to talk to your doctor, family members or friends about deciding to join a trial.
It is important to know as much as possible about the trial and you should not feel uncomfortable about asking any questions when speaking to members of the health care team.
What are clinical trials?
A clinical trial is a research study in patients to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Medevol now manages trials in most Hospitals and numerous Health Centres across Northern Ireland. These trials only begin after laboratory studies have outlined the potential safety of a new treatment or procedure and that it has the potential to work better than existing methods.
A patient must qualify for the study prior to joining a clinical trial. Some research studies require healthy participants while others require patients with specific illnesses or conditions. The criteria for study entry are used to indentify appropriate partcipants and keep them safe as well as ensuring that researchers are able to answer the questions they plan to study.
What information do clinical trials provide?
Any new treatment or procedure will be investigated using a whole series of clinical trials, each one designed to answer a specific set of questions.
Clinical trials are also organised into different phases of research, in order to build up a greater understanding of the new treatment, before it is approved or recommended for routine use.
Phase I - the first studies in humans are Phase I trials. They are performed with small numbers of patients or healthy volunteers and are used to answer questions such as what dose of the drug is likely to be effective and what side effects might occur.
Phase II - these trials continue this process with larger numbers of patients. They have a greater focus on how well the treatment or procedure works, perhaps in particular situations or groups of patients.
Phase III - these trials enrol large numbers of patients and are used to compare the effectiveness and safety of the new treatment with that of the standard existing treatment. Information obtained from large Phase III trials that demonstrates the benefits of a new drug over existing treatments is sometimes presented to regulatory authorities in order to obtain a licence to market and sell the drug.
Phase IV- these trials are post marketing studies which provide additional information including the drug’s benefits, risks and optimal use.
Patient participation
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
There are guidelines about who can participate in each individual trial. The main factors that allow a patient to participate are called inclusion criteria and those that disallow someone from participating are called exclusion criteria. These criteria are based on factors such as age, gender, the type and stage of disease, previous treatment history and other medical conditions.
A patient must qualify for the study prior to joining a clinical trial. Some research studies require healthy particpants while others require patients with specific illnesses or conditions. The criteria for study entry are used to identify appropriate participants and keep them safe as well as ensuring that researchers are able to answer the questions they plan to study.
Patient FAQs
What happens during a clinical trial?
The specific clinical trial process depends on the actual trial being conducted. Doctors, nurses and other health professionals are involved and check the health of the participant at the beginning of the study, give specific instructions for participating in the trial and monitor the participant throughout the trial.
What is informed consent?
This is the process of learning the key facts about a clinical trial before deciding whether or not to participate. The doctors and nurses involved in the trial will explain the study details and provide a patient information leaflet which details the study design, its purpose, duration, required procedures and contacts. Risks and potential benefits are explained and if you wish to participate you will be asked to sign the consent form. Informed consent is not a contract and you are free to withdraw from the trial at any time without explanation and will be offered the regular treatment for your condition.
Who sponsors clinical trials?
Trials are sponsored or funded by a variety of organisations or individuals including medical institutions/universities, physicians, voluntary groups, pharmaceutical companies in addition to government agencies.
Where do trial ideas come from?
Ideas usually come from researchers. After researchers test new molecules or therapies in the laboratory, the compounds with the most promising results are moved onto clinical trials. During a trial, alot more information is gained about a new treatment, its risks and how well it may or may not work.
What is a placebo?
A placebo is an inactive pill, liquid or powder that has no treatment value. Experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
What are the benefits and risks of participating in trials?
Trials are the best approach for eligible patients to gain access to new research treatments before they are widely available play an active role in their own health care obtain expert medical care at leading healthcare facilities during the trial help others by contributing to medical research
What are the risks of participating in trials?
There may be unpleasant or side effects to treatment The treatment may not be effective The study may require more trips to the hospital/health centre and more treatments.
How is the safety of the participant protected?
Trials are governed by regulatory bodies and Ethics committees to ensure that patient safety is a priority in the design and conduct of a clinical trial. As a clinical trial progresses, researchers report the results of the trial at scientific meetings and to various government agencies. Individual participants names will remain secret and will not be mentioned in any reports.