Glossary
Click on the terms below to go to a description of that term. To return to the top of this page click the ' >> back to the top' link which appears at the end of every description.
Advance Decision (see also advance directive)
Advance Directive (see also advance decision)
Advocate
Adverse reactions
Arms
Baseline measures
Bias
Blinding and double-blinding
Chief investigator
Clinical trial
Confidentiality
Control group
Court of Protection
Cross-over trials
Data monitoring committee (Often called the Independent Data Monitoring and Ethics Committee - IDMEC).
Data Protection Act
Double-blind trials See blinding
Drug interaction
Eligibility criteria
Enduring Power of Attorney
Exclusion criteria
Guardian
Health Technology Assessment (HTA) programme
Inclusion criteria
Informed consent
Intervention
Lasting Power of Attorney
Medical Research Council
Mental capacity
Mental Health Research Network (MHRN)
Meta-analysis
MHRA
Open trial
Open label trials
Outcome measures
Placebo
Protocol
Quality of life studies
Randomised controlled trial
Researcher
Research ethics committee
Side effects
Sponsor
Trial Steering Committee
UK Mental Health Research Network (see MHRN)
Welfare attorney
Advance Decision (see also advance directive)
Advance decisions to refuse treatment may be made by people before they become ill, in case they lose capacity in the future. It is made clear in the Mental
Capacity Act 2005 that advance decisions will not apply to any treatment that a doctor considers necessary to sustain life, unless they are in writing,
signed and witnessed and contain an express statement that the decision stands “even if life is at risk”.
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An Advance Directive is a written statement made when a person is well about what they want to happen to them if they experience a relapse.
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An advocate is someone who has been trained to speak up for others or to help them speak up for themselves. They can help people make decisions about
joining a clinical trial or support them during a trial.
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Adverse reactions, are unwanted side effects, caused by a drug or other treatment. For example, if you are given a drug to treat a mental illness and it
makes you sick, the sickness would be described as an adverse reaction.
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An arm is one of the treatment groups in a trial. If a trial is testing 2 treatments, there will be 2 ‘arms’. One arm might be the usual treatment.
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At the beginning of a trial you may have to answer questions about your medical history, or how you are feeling now, or have some tests before being given
the treatment. These are called baseline measures. These measures will allow the researchers to know where you started, so they can tell at the end of the
trial whether there has been any change.
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When people’s individual opinions lead to incorrect conclusions about the effects of treatment, this is bias. It’s really important to avoid bias in
health research, as it can distort the results and could lead to unsafe or inefficient treatments being licensed for use, or useful treatments being
overlooked. Researchers try to avoid bias by using randomisation and by ‘blinding’ those assessing the results of treatments.
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Blinding means that whoever is assessing the effects of treatment will not know which treatment the person has received. This helps to prevent bias. Sometimes service users will assess the effects of treatment, sometimes the researcher will, and sometimes a researcher who is independent of the trial will carry out this assessment. Blinding means that some or all of these people may be kept unaware of which treatment the person has received. In a double blind trial, neither you nor the researchers running the trial will know which treatment you are receiving. The aim is to avoid your hopes and expectations about the treatment, as well as the hopes and expectations of the researchers, influencing the way the improvements and side effects are assessed.
It is not always possible to avoid researchers and service users knowing which treatment they are having. For example, the trial may be comparing an
injection with a tablet. If the researcher knows which treatment you are receiving, it may be necessary for another researcher, who has not been involved in
conducting the trial, to assess the impact of the different treatments.
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The chief investigator (also called a principal investigator) is the researcher in overall charge of a trial. If you take part in a trial you may never
meet the chief investigator, especially if the trial is very large and taking place in several countries. But this person is responsible for the design of
the trial and how it is run, as well as for analysing the results. He or she is helped by a trial steering committee and a data monitoring committee.
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Clinical trials are research studies involving patients, which compare a new or different type of treatment with the best treatment currently available.
No matter how promising a new drug or treatment may appear during tests in a laboratory, it must go through clinical trials before its benefits and risks can
really be known, and before it is approved for use.
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If you agree to join a trial, some people will need to be told that you are taking part. These people are:
- Your GP, as he or she is responsible for your healthcare on a day-to-day basis
- Your mental health care team
- The doctor and research team looking after you in the trial
If there is someone who provides you with substantial care and support (for example a carer) it would be good for them to know too, so that they have the information they need to support you.
The fact that you are taking part in a trial will be written in your medical notes. Researchers cannot tell anyone else that you are taking part in a trial unless you give your permission.
During the trial, all of the information collected about you will be kept confidential, as with any other medical records. When researchers publish the
results of a trial, they are not allowed to include any information that would identify people - your name will not be used in any reports or publications.
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Most clinical trials include a control group. If you are part of the control group, you will not receive the treatment being trialled. Instead, you’ll
receive the usual treatment, or, if there is no usual treatment, a placebo.
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The Mental Capacity Act 2005 has created a new Court of Protection which has jurisdiction relating to the whole Act and is the final arbiter for capacity
matters. It has its own procedures and nominated judges. The old Court of Protection could only deal with decisions about money, but the new Court will be
able to make decisions about medical treatment which used to have to go to the High Court.
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If you take part in a crossover trial, your treatment will change partway through the trial. So, for example, if a trial is comparing the effectiveness of
2 different sorts of exercise to help combat depression, you might take part in exercise A for the first part of the trial and then exercise B for the
second, then perhaps back to A again - and so on. You cross over from one treatment group to the other, and comparisons are then made between how well you
felt during the different periods. Often there will be several cross-overs in a cross-over trial.
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Most trials have a data monitoring committee that follows the progress of the trial and makes sure it is being run properly. The people on the data
monitoring committee are independent of the researchers running the trial. If they think that participants are experiencing serious or unexpected side
effects, or if evidence has emerged that one of the treatments being compared is clearly better than the others, they can advise that a trial is stopped.
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The Data Protection Act 1998 seeks to strike a balance between the rights of individuals and the sometimes competing interests of those with legitimate
reasons for using personal information. The DPA gives individuals certain rights regarding information held about them. It places obligations on those who
process information (data controllers) while giving rights to those who are the subject of that data (data subjects). Personal information covers both facts
and opinions about the individual.
For more information click here.
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Drug interactionIf you take two different medicines at the same time, they may have a different effect than if they are taken on their own. One may cancel the effects of
the other or the two may cause more serious side-effects when taken in combination. This is called drug interaction.
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All trials have guidelines about who can take part. These are called 'eligibility criteria', consisting of inclusion criteria and exclusion criteria. For
example, the eligibility criteria for a trial looking at bi-polar disorder might say that the only people who can take part are people who are over 18 but
under 80, and who have no other health problems.
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An Enduring Power of Attorney (EPA), is a legal document that enables someone (the donor) to appoint one or more persons (attorney(s)) to manage their
financial affairs and property, either now or in the future.
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Exclusion criteria determine who won’t be able to join a trial – for example, many trials exclude women who are pregnant, or who may become pregnant. This
avoids any possible danger to a baby. Trials may also exclude people who are taking a drug that interacts with the treatment being studied.
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Under Scottish law, a guardian is someone who is legally recognised as the person acting for another adult who lacks mental capacity.
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The purpose of the HTA programme is to ensure that high quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most effective way for those who use, manage and provide care in the NHS.
Health technology is a term that covers any method used by those working in the health services to promote health or prevent, diagnose and treat disease
and improve rehabilitation and long-term care. 'Technologies' in this context are not confined to new drugs or pieces of sophisticated equipment, but include
procedures, settings of care and screening programmes.
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Inclusion criteria help researchers decide who can join a trial. For example, some trials only include people of a certain age, or at a particular stage
in their illness. You may have to have a medical examination before a trial (e.g. a blood test) to assess whether you are suitable to take part. (See also
eligibility criteria)
Independent scientific review (also known as peer review)
This is the process which involves independent researchers (people are not connected with the clinical trial) looking at the trial protocol to check its
scientific quality before the trial begins. They check that the research question is important and that the protocol reaches required scientific standards
e.g. that the question has not been answered before, enough people are involved to make the results meaningful, and the methods are appropriate.
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You cannot be entered into a trial without signing a form saying that you have given your informed consent, except in extreme circumstances (for example, if you're admitted to hospital in an emergency and you're unconscious). If you sign this form, you are saying that you believe you have been given all the important facts about a trial, you understand them and that you have decided to take part in the trial of your own free will. Even after giving your informed consent, you are free to withdraw from the trial at any time without giving a reason and without it having an impact on your healthcare.
The Mental Capacity Act 2005 has strict rules about entering people into a trial without informed consent – researchers must consult a carer or nominated
person, and if these cannot be found, and it is urgent to enter the person into a trial, they must have the agreement of a registered practitioner who is not
involved in the research project.
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Within the context of healthcare, an intervention is something that is given to a service user as a treatment. For example, giving a drug is an intervention.
Counselling is also an intervention. Within the context of a clinical trial, the ‘intervention arm’ is the name given to the group of people receiving the
new treatment.
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The Mental Capacity Act 2005 allows a person to appoint an attorney to act on their behalf if they should lose capacity in the future. This is like the
current Enduring Power of Attorney (EPA), but allows the attorney to make health and welfare decisions as well as financial ones. It is called Lasting Power
of Attorney (LPA).
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The UK Medical Research Council (MRC) is a national organisation funded by the UK taxpayer. It funds and supports research in many areas with the aim of
improving the health and quality of life of the UK public and contributing to the wealth of the nation.
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Under the Mental Capacity Act 2005, you can be deemed to lack mental capacity if you are unable to make a decision for yourself “because of an impairment
of, or a disturbance in the functioning of, the mind or brain.”
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The UK MHRN aims to provide the infrastructure to support large scale, high quality research in mental health and social care in the UK. It also aims to act as a central point of information and reference, connecting service users and carers to researchers and mental health professionals. For more information click here.
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Small beneficial effects of treatments, rather than miracle cures, are often the best that can be hoped of new medical treatments. These small
improvements can be very important, but many trials do not manage to recruit sufficient numbers of participants to detect these small improvements. This
means that researchers cannot give an accurate answer about how safe or effective a new treatment is. In this case, researchers can bring together the
results of a number of similar trials to give a fuller answer about the value of a particular treatment. This method of combining results of more than one
trial is called a meta-analysis.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is a part of the Department of Health. Its job is to protect and promote public health and
patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and
effectiveness, and are used safely.
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An open trial has different meanings:
- A trial that is still recruiting people. When a trial is closed, it stops recruiting people and the researchers collect and analyse the results, ready for publication.
- A trial where the researcher and the participant know which treatment they are receiving – they are not blinded (see blinding). This is also called an open label trial.
In an open label trial, both you and your doctor will know which treatment you are receiving. This is the opposite of a double-blind trial.
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During the trial you are likely to be asked questions and have examinations and tests to assess the effects of treatment. These are known as outcome
measures. This may involve more visits to the clinic than normal, or more tests than normal - for example, extra blood might be taken when you give a blood
sample. Sometimes the tests are carried out as part of your routine care.
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A placebo is a fake or dummy treatment. It allows researchers to test for the 'placebo effect'. This is a psychological response where people feel better
even though the treatment they are receiving is not working. By comparing people’s responses to the placebo and to the treatment being tested, researchers
can tell whether the treatment is having any real benefit. Placebos are designed to be harmless to have no effect, but they may make people feel better.
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A protocol is the plan for the trial, and it must include information on:
- What question the trial is asking
- How many people will be involved
- Who can take part in the trial - the eligibility criteria
- What treatments will be compared
- What tests people taking part in the trial will have and when they will have them
- Details about how and when information will be collected
The protocol is often long and technical as it describes in great detail what the researchers must do during the trial. This is the document they
continually work from. It cannot be changed without going back to a research ethics committee for approval.
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As well as measuring the physical effects of a treatment (for example changes to your blood pressure), many trials now try to assess the impact of treatments on people’s quality of life. For example, a ‘quality of life’ study might ask you about:
- Your mood and general sense of well-being
- Whether you feel more tired than usual
- Whether you are managing to do more things than before
- Whether you feel more like socialising
- Whether your sleep patterns have changed
Most clinical trials are randomised controlled trials. If you take part in a randomised trial, a computer, not a doctor, will decide which treatment to give you. This decision will be random. It will be due to chance alone, and not based on your doctor’s decision.
Randomisation is the best way of ensuring that people in the different parts of a trial are broadly similar. By comparing similar groups of people, researchers can be sure that their trial is checking the difference between the treatments being studied, and not the differences between the people taking part.
Randomisation is important because researchers need to ensure that the results of a clinical trial are not biased. It is quite easy for people to be biased without realising it. For example, suppose a new treatment is being tested that has quite bad side effects. Without randomisation, researchers, doctors and the sickest patients might avoid the new treatment. As the trial continued, more and more of the sickest patients would join the comparison group getting the old treatment, so this group would then have more and more of the sickest patients in it. The people in the new treatment group might do better simply because they are not as ill when they started the treatment. These results could be interpreted wrongly – people might believe that the new treatment works better than the old one. Randomising patients to different treatment groups avoids biasing the results in this way.
A randomised controlled trial has a control group. This is a group of people who are offered the usual (or standard) treatment. If there is no usual treatment, they will be offered a placebo. The control group provides a comparison to help researchers to see whether the treatment they are testing is any more or less effective.
You should only be asked to take part in a randomised controlled trial if both you and your doctor are uncertain which treatment would be best for you.
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This site uses the term researcher to refer to health or social care professionals who provide treatment to participants in a clinical trial.
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The job of a research ethics committee is to make sure that research carried out in the NHS respects the dignity, rights, safety and well-being of the people who take part in medical research. A trial that takes place within the NHS cannot go ahead if a research ethics committee has not approved it, and the protocol for a trial cannot be changed without the approval of the research ethics committee. Research ethics committee members include researchers and health care professionals as well as members of the public.
Research Governance Framework for health and social care The Research Governance Framework was developed by the Department of Health to improve research quality and to safeguard the public. It aims to do this by
- Enhancing ethical and scientific quality
- Promoting good practice
- Reducing adverse incidents and ensuring lessons are learned
- Preventing poor performance and misconduct
For more information click here.
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Side effects, or adverse reactions, are undesired effects of a treatment. For example, if you are given a drug to treat a mental illness and it makes you
sick, the sickness would be described as a side effect. Clinical trials will often look at the short-term and long-term side effects of a treatment.
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Under the Research Governance Framework for health and social care, the sponsor is the individual, group or organisation which takes responsibility for
checking that there are proper arrangements to initiate, manage, monitor and finance a piece of research. Any research that takes place in the NHS or social
care in England must have a sponsor. Normally, the sponsor will be one of the organisations taking the lead for part or all of the research.
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Most trials have a trial steering group or committee. This is to ensure the trial is running well. In the UK, this committee often includes service user
or carer representatives, as well as the researchers, doctors and nurses who are leading the trial.
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Under Scottish law, a welfare attorney is someone who is legally contracted or appointed to make decisions about the personal welfare of an adult who
lacksmental capacity.
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