Listed below are some terms/words that are used frequently
(There are many others please see : https://www.centerwatch.com/health-resources/glossary/)
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)
Cohort
. 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
Efficacy
. the ability of a drug or treatment to produce positive results.
Eligibility
. 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.
Enrolling
. 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
Efficacy
. ability of a drug or treatment to produce positive results
Investigator
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
Recruiting
. The time period when patients are being identified and enrolled in the trial
Randomisation
. This is a trial method
. Participants are selected randomly and either get the drug/treatment being studied or the standard treatment
Sponsor
. 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 ***