Home Forums Other Specialities General Topics PATIENT LEAFLET -WHAT ARE CLINICAL TRIALS ?

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    What are clinical trials?
    A clinical trial is a particular type of clinical research that compares one treatment with another. It may involve patients or healthy people, or both.
    Small studies produce less reliable results than large ones, so studies often have to be carried out on a large number of people before the results are considered sufficiently reliable.

    Why clinical trials are important
    Doctors and other healthcare professionals and patients need evidence from clinical trials to know which treatments work best. Without this evidence, there is a risk that people could be given treatments that have no advantage, waste resources, and might even be harmful.

    Clinical trials help to find out if:
    treatments are safe
    treatments have any side effects
    new treatments are better than available standard treatments.

    Many treatments have been tested in clinical trials.
    The evidence for some treatments is incomplete ,what we don’t know.

    What clinical trials can find out
    Clinical trials can help:
    prevent illnesses by testing a vaccine
    detect or diagnose illnesses by testing a scan or blood test
    treat illnesses by testing a new medicine
    find out how best to provide psychological support
    find out how people can control their symptoms or improve their quality of life by testing how a particular diet affects a condition.

    Trials follow a set of rules, known as a protocol, to ensure they are well designed and as safe as possible, that they measure the right things in the right way, and that results are meaningful.
    A full protocol should be available to anyone who is considering taking part in a trial and wants to see it.
    Many clinical trials are designed to show whether new medicines work as expected.

    Questions to ask
    When you express interest in a trial, a doctor or nurse is likely to tell you something about it in person. You will also be given some printed information to take away.
    You may come back with some questions that you feel have not been answered.

    General questions
    What is the aim of the trial and how will it help people?
    Who is funding the trial?
    What treatment will I get if I do not take part in the trial?

    How long is the trial expected to last and how long will I have to take part?
    How long will it be before the results of the trial are known?
    What will happen if I stop the trial treatment or leave the trial before it ends?

    Practical questions
    How much of my time will be needed?
    What extra tests or appointments will I have?
    Will I need to take time off work?
    Will I need extra help from family or friends?

    Will the costs of my travel to take part in the trial be covered?
    If the trial is testing a new drug, will I have to collect it from the hospital, will it be sent to me by post, or will I get it through my doctor?
    Will I have to complete questionnaires or keep a diary?

    What are the possible side effects of my treatment?
    How could the treatments affect me physically and emotionally.

    Who can I contact if I have a problem?
    Will someone be available 24 hours a day?
    How do I find out the results of the trial?

    Advantages of being in a clinical trial
    The main reason for carrying out trials is to determine whether one treatment is better than another. An advantage of being involved in a trial is that you may be given a new treatment that is better for your condition.

    During the trial, your treatment and progress may be monitored more closely than if you were receiving the usual treatment.
    After the trial has finished, health professionals will be better able to offer you the most appropriate and effective treatment for you.

    Trials are very important in helping find better treatments. By being involved in a trial, you will obtain information and evidence that may be helpful to you in the future, as well as helping the Doctors to give people the best possible standard of care.

    Disadvantages of being in a clinical trial
    The disadvantages are:
    As with any treatment, you cannot be sure of the outcome.
    You may be given a new treatment that turns out not to be as effective as the standard treatment.
    It is possible that you will experience unexpected side effects.
    You may have to visit your place of treatment more often, or have more tests, treatments or monitoring than you would if you were receiving the standard treatment in usual care.

    Giving consent
    You cannot be entered into a trial if you don’t want to be. If you’re asked to take part, you’re free to say yes or no at any time.
    For people under 18, a parent or guardian has to give permission.

    The doctor organising your treatment will usually talk to you about being involved. They should explain the possible risks and benefits.

    Make sure you are happy with the trial and have been given all the information you want before you give your consent. This may mean taking some time to think about it and talk it over with family or friends, unless a decision is needed urgently because of your medical condition.
    If you decide to take part, you will be asked to sign a form to say that you are agreeing to take part in a trial and have understood what that will involve.
    This is called giving your informed consent.

    Why you might not be able to take part
    Sometimes, it is not possible for you to be involved in a particular trial. For example:

    Your condition may need to be at a particular stage.
    You may not be allowed to receive another treatment at the same time.
    Some trials seek people with certain illnesses and conditions, while others need healthy people.
    Some trials need people of a certain age.
    There may already be enough people in a particular category who have joined the trial.

    Medical tests
    Before you join a trial, you may need to have tests to see if you can take part. For example, you may have to be tested to see if you have raised levels of a particular hormone.
    This will allow the researchers to know more about your health before you start treatment, so at the end of the trial they can tell if there’s been an improvement.

    During the trial, you may have more tests to see whether the treatment is working. It may be possible for the tests to be carried out as part of your routine care, or you may have to make more visits than usual to your GP or hospital clinic.

    Leaving a trial
    You may decide to stop taking part in a trial if your condition is getting worse or if you feel the treatment is not helping you. You can also choose to leave at any point without giving a reason, and without it affecting the care you receive.
    If there are signs that the treatment in a trial could be unsafe, the research team or the regulators will stop the trial .

    G Mohan.

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