Glossary of clinical trials

Glossary of Clinical Trials

Clinical trials (pronunciation: /ˈklɪnɪkəl ˈtraɪəlz/) are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.

A

Adverse Event (pronunciation: /ˈædvɜːrs iːˈvɛnt/): Any undesirable experience associated with the use of a medical product in a patient.

B

Blinding (pronunciation: /ˈblaɪndɪŋ/): A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).

C

Control Group (pronunciation: /kənˈtroʊl ˈɡruːp/): The group in a clinical trial that receives either no treatment, a standard treatment, or a placebo.

D

Double-Blind Study (pronunciation: /ˈdʌbəl blaɪnd ˈstʌdi/): A clinical trial design in which neither the participants nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy).

E

Endpoint (pronunciation: /ˈɛndˌpɔɪnt/): Overall outcome that the protocol is designed to evaluate.

F

Follow-Up Study (pronunciation: /ˈfɒloʊˌʌp ˈstʌdi/): Studies in which individuals are followed over time to observe the outcome under investigation.

G

Good Clinical Practice (pronunciation: /ɡʊd ˈklɪnɪkəl ˈpræktɪs/): An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

H

Human Subject (pronunciation: /ˈhjuːmən ˈsʌbdʒɪkt/): An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.

I

Informed Consent (pronunciation: /ɪnˈfɔːrmd kənˈsɛnt/): A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate.

J

Justification of Study (pronunciation: /ˌdʒʌstɪfɪˈkeɪʃən ʌv ˈstʌdi/): A statement explaining why the study is being done and what it is expected to achieve.

K

Key Eligibility Criteria (pronunciation: /kiː ɪˌlɪdʒɪˈbɪlɪti kraɪˈtɪəriə/): The principal factors that determine whether a person is suitable to participate in a clinical trial.

L

Longitudinal Study (pronunciation: /ˌlɒndʒɪˈtjuːdɪnəl ˈstʌdi/): A study that follows participants over a long period of time.

M

Monitoring (pronunciation: /ˈmɒnɪtərɪŋ/): The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

N

Null Hypothesis (pronunciation: /nʌl haɪˈpɒθɪsɪs/): The hypothesis that there is no significant difference between specified populations, any observed difference being due to sampling or experimental error.

O

Observational Study (pronunciation: /ˌɒbzərˈveɪʃənəl ˈstʌdi/): Studies in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given).

P

Placebo (pronunciation: /pləˈsiboʊ/): A placebo is an inactive pill, liquid, or powder that has no treatment value.

Q

Quality Assurance (pronunciation: /ˈkwɒlɪti əˈʃʊərəns/): All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

R

Randomization (pronunciation: /ˌrændəmɪˈzeɪʃən/): The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

S

Single-Blind Study (pronunciation: /ˈsɪŋɡəl blaɪnd ˈstʌdi/): A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study.

T

Trial Design (pronunciation: /ˈtraɪəl dɪˈzaɪn/): The way in which a clinical trial is structured, including its randomization scheme, blinding status, and the number of treatment arms.

U

Unblinding (pronunciation: /ʌnˈblaɪndɪŋ/): The revealing of the treatments that individual participants receive in a blind study.

V

Volunteer (pronunciation: /ˌvɒlənˈtɪər/): A person who willingly offers himself or herself for a service or undertaking.

W

Withdrawal Criteria (pronunciation: /wɪðˈdrɔːəl kraɪˈtɪəriə/): The conditions under which a participant must be withdrawn from a trial.

X

Exclusion Criteria (pronunciation: /ɪkˈskluːʒən kraɪˈtɪəriə/): The characteristics that prevent a potential participant from participating in a trial.

Y

Yearly Review (pronunciation: /ˈjɪərli rɪˈvjuː/): A yearly evaluation of the trial by the sponsor.

Z

Zero Tolerance (pronunciation: /ˈzɪəroʊ ˈtɒlərəns/): A policy of not allowing any deviations from the protocol or Good Clinical Practice.

External links

• Medical encyclopedia article on Glossary of clinical trials
• Wikipedia's article - Glossary of clinical trials

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