FAQ/Glossary
FAQ - Frequently Asked Questions
What is a clinical trial?
Clinical trial is a research study designed to answer specific questions about new medicines, therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work for people.
What types of trial are there?
Trials are in four phases: Phase I trials test a new drug or treatment in a small group of healthy individuals (usually volunteers); Phase II trials administer the drug or treatment to trial participants with the target disease; Phase III trials expand the study to an even larger group of people with the target disease to test reliability/validity; and Phase IV trials take place after the drug or treatment has been licensed and marketed.
What is informed consent?
The process of learning the key facts about a clinical trial before deciding whether or not to participate is known as informed consent. To help someone decide whether or not to participate, the doctors and nurses involved in the trial provide impartial information on the details of the study. Each study also has a participant information sheet which states why the particular clinical trial is being done, what procedures will be done during the course of the study, what possible risks there may be and information about the rights and responsibilities of a study participant. The study consent form must be signed by the clinical trial participant before any study procedure can begin. Informed consent is a continual process whereby any new information that comes to light during the trial must be provided to participants.
What is an ethics committee?
A research ethics committee is a committee of doctors, statisticians, researchers, lay people and others that ensure that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the UK must be approved by an ethics committee before they begin. The ethics committee initially approves and then periodically reviews the research in order to protect the rights of human participants.
Are there risks in clinical trials?
The process of evaluating new treatments can involve some risk. Although drugs are tested extensively in the laboratory prior to being given in a clinical trial, some side effects do not become apparent until the treatments are given to humans. Side effects can vary from person to person. It is important to remember that clinical trials can carry unknown dangers as well as possible benefits.
Glossary
BP: Blood pressure.
CAMS: Abbreviated term for Cannabinoids in Multiple Sclerosis Study (2003), coordinated by the CNRG.
Disease-modifying (drugs): Disease modifying therapies can be given to people
with MS to try and alter the course of the disease. Current therapies generally
do this by reducing the number and severity of relapses in relapsing remitting
disease, in the hope that this will slow down the rate of progression of
the disease. Currently research suggests that these therapies are not helpful
in progressive disease when there are no relapses present.
Expanded Disability Status Scale (EDSS): Method of quantifying disability
in multiple sclerosis. It consists of a neurological exam which is
performed by your study doctor. It can take between 20 and 30 minutes.
Magnetic Resonance Imaging (MRI): is a diagnostic procedure that
uses a magnetic field to provide three-dimensional images of internal
body structures.
Monitor side effects: at each visit your study doctor will ask about
your general health and whether you have had any side effects from
your medication.
Multiple Sclerosis Functional Composite (MSFC): A three part assessment
of function in multiple sclerosis. It includes a timed 25-foot walk,
a peg test (placing pegs in holes and removing them by hand) and
a number counting exercise. These assessments take about 15-20 minutes
to complete and will be carried out by a nurse, a doctor or possibly
a therapist.
Placebo: An inactive substance or treatment that looks the same as,
and is given the same way as, an active drug or treatment being tested.
The effects of the active drug or treatment are compared to the effects
of the placebo.
Progressive MS: People with primary progressive MS experience a slow
but nearly continuous worsening of their disease from the onset,
with no distinct relapses or remissions. However, there are variations
in rates of progression over time, occasional plateaus, and temporary
minor improvements. People with secondary progressive MS experience
an initial period of relapsing-remitting disease, followed by a steadily
worsening disease course with or without occasional flare-ups, minor
recoveries.
Publicly funded study: Where funding for a clinical trial has come
from a publicly financed source i.e. research council, charity or
NHS funded studies.
Random: this type of study is known as a 'randomised trial' which
means that your treatment will be chosen randomly (by chance) by
a computer at the beginning of the trial.
Relapsing-remitting MS: People with this type of MS experience clearly
defined flare-ups (also called relapses, attacks, or exacerbations).
These are episodes of acute worsening of neurological function. They
are followed by partial or complete recovery periods (remissions)
free of disease progression (remissions), or plateaus.
Significant relapse: A worsening of existing neurological symptom(s)
which lasts for at least 48 hours, or the appearance of a new neurological
symptom which lasts for at least 48 hours. It is significant if disability
worsens to a point that day to day activities are severely curtailed.
THC: Tetrahydrocannabinol is the main active ingredient in the cannabis
plant.