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Clinical trials Glossary - Understanding the language of clinical trials

Listed below are some terms/words that are used frequently
(There are many others please see :​)

Adverse reaction
. An unwanted side effect
Control group
.  A group of patients who do NOT get the treatment/drug being studied. This group get the "standard treatment" (treatment already in use and thought to be the best available)
.  A group of patients with some characteristics in common
Dosage Regimen
.  How often is the drug/treatment given
.  How much/what quantity of the drug/treatment is given
.  the ability of a drug or treatment to produce positive results.
.  The reasons  a person is allowed to take part in a particular trial
.  Eligibility includes Inclusion and exclusion criteria which may include age, gender, number of other treatments etc.
.  Signing up
Ethics committee
. An independent board set up to ensure participants are safe during the trial
Expanded access
.  Use of a drug/treatment not yet approved
.  Use of drug/treatment outside of a clinical trial
. ability of a drug or treatment to produce positive results

Open-label Trial
.  a clinical trial in which both the research staff and the participants know which drug or treatment is being studied.
Phases of clinical trials
.  Generally there are 4 phases sometimes 5
Phase 1
.  Usually a small number of participants
.  The safety of the drug is tested
.  What dose  can be tolerated
.   To see how it works and what the side effects are
Phase 2
.  Tested on a larger group
.  To test further how it is working on the body
Phase 3
. Multi centre studies
. Overall safety
. How effective is it and how can it improve quality of life
Phase 4
. Final stage of process is to get state approval
. The time period when patients are being identified and enrolled in the trial
.  This is a trial method
.  Participants are selected randomly and either get the drug/treatment being studied or the standard treatment
.  The organisation running the trial
Side effect
.  An unwanted effect of the drug/treatment
Standard treatment
.  This is the drug/treatment believed to be the best option and is already available to the patient

*** This draft is as of 22/11/18 - to be updated as reguired ***

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