Here
you will find further information about clinical trials.
Click on a link below to jump to a topic.
Questions about health care which lead to trials can come from
patients, people working in the NHS, researchers, organisations
that fund research, drug companies or policymakers.
Researchers planning a trial will draw up a protocol. This
is the detailed plan for the trial, and it must include:
- What the trial is aiming to find out
- The design of the trial – for example how many different groups
there will be, whether the trial will be blinded
- How many people will be recruited
- The eligibility criteria – who can take part in the trial
- What treatments are being compared
- What tests people taking part in the trial will have and when
they should have them
- Details about how and when information will be collected
When researchers apply for funding to run a trial, the protocol
is sent for independent scientific review. If the trial is
funded, the researchers send the protocol to an ethics committee
for approval. The trial cannot start without ethics committee
approval.
Back to top
Some trials, including many of the trials we run at the MRC
Clinical Trials Unit, try to look at the effect on people’s quality
of life when they are given a new treatment when compared to the
usual treatment. A "quality of life" study might look at
whether:
- You are managing to lead the life you would lead normally –
going to work, looking after your family, or whatever you would
normally do
- You feel depressed or get angry more easily than usual
- You feel more tired than usual
Read more about the work that we do at the MRC Clinical
Trials Unit about quality of life
Back to top
Many different organisations might pay for trials to take
place. For example:
- The NHS or Medical Research Council. At
the MRC Clinical Trials Unit, we run trials funded by the MRC and
the NHS looking at treatments for different types of cancer,
HIV/AIDS and other illnesses
- Other government agencies, which might want to
help address health problems in developing countries. At the
MRC Clinical Trials Unit we are running trials looking at a
treatment that might prevent HIV/AIDS. This is funded by the
Department for International Development
- Charities, who want to find out more about
best treatments for a particular illness, such as Cancer Research
UK. At the MRC Clinical Trials Unit, we help to run trials
for the Arthritis Research Campaign
- Drugs companies conduct most clinical trials
in the UK and elsewhere. They need to run trials to test new
drugs or other treatments. At the MRC Clinical Trials Unit,
drugs companies help to fund some of our trials and may also give
us the drugs we are testing free of charge or at a reduced
price
Back to top
Many phase III trials need to involve thousands of people, and
they may run for a long time – sometimes five years or
longer. Trials must be monitored as they go along, to ensure
that everything is going as planned. There is usually an
independent Data Monitoring Committee, which monitors the progress
of a trial.
There is also usually a Trial Steering Committee, which makes
sure the trial is running well. This committee might include
patient representatives as well as the researchers leading the
trial, doctors and nurses and an independent chairperson.
Back to top
At the end of a trial, all of the results are gathered together
and analysed. The researchers may look at:
- How effective a treatment is
- How safe it is
- Whether it has any side effects
- Whether it is better than the current treatment (or
placebo)
- How much, or how often a treatment should be used
Researchers have a responsibility to publicise the results of
their trial. They usually do this at a conference, or in a
medical journal, and sometimes in the press. Some researchers
give the results directly to the people who took part in the trial,
if they want to see them. Some researchers work with
charities and self–help groups to ensure that the results of trials
reach other patients who might find them of interest.
At the MRC Clinical Trials Unit, we publish the results of all
of our research – at conferences, in journals, and in partnership
with patient organisations.
Click here to go to
a list of our publications.
We are currently writing plain English summaries of the results
of all of our research.
Back to top
Systematic reviews are studies that bring together the results
of previous research (usually randomised trials) about one
particular treatment. Researchers who do systematic reviews
try to uncover all the relevant trials worldwide and to evaluate
them in a fair and objective way.
Often trials that find a particular treatment works well get
more publicity. Trials that find that the same treatment has
no effect, or is harmful, get less publicity and so people may not
be aware of them. Researchers who do systematic reviews are
careful to look at the results from all relevant trials, no matter
what their results. Looking at all the trials also means that
the researchers can see the bigger picture. Doing a
systematic review is rather like gathering together all of the
pieces you need to complete a jigsaw puzzle. The completed
puzzle (the systematic review) tells us more about the picture than
any of the individual puzzle pieces (the trials).
Where possible the numerical results of all the trials are
combined to measure better how well a treatment works.
Combining the results in this way is called a meta-analysis.
A meta-analysis can be important because it allows us to pick up
small differences between treatments. These differences can be very
hard to spot, so trials need to include large numbers of patients
to pick these up. Also if trials are not big enough, we may find
differences that we find are because of differences between the
treatments just by chance. By bringing together the results of all
trials of a particular treatment in a meta-analysis, we can look at
the experience of many more patients. This gives a more reliable
and precise measurement of the effect of the treatment and a good
chance of seeing which treatments are best.
More information about systematic reviews and
meta-analysis
Back to top
Last Update Date : 7/6/2009
