Page 44 - Terminology-Clinical-Research

conducted in a relatively small number of patients, usually blind.
involving no more than several hundred subjects.
Placebo comparator arm: A group of participants that
Phase 2A: Controlled clinical studies that occur after the receives a placebo during a clinical study. One of several
completion of Phase 1 studies and the first set of exposure- arm types.
response studies in patients, and before beginning Phase
2B (i.e., patient dose-ranging trial) and Phase 3 clinical Placebo: A substance that does not contain active
efficacy-safety studies. ingredients and is made to be physically indistinguishable
(that is, it looks and tastes identical) from the actual drug
Phase 3: Studies are expanded controlled and uncontrolled being studied.
trials. They are performed after preliminary evidence
suggesting effectiveness of the drug has been obtained Placebo controlled trial: A method of drug investigation
and are intended to gather the additional information in which an inactive substance (a placebo) is given to one
about effectiveness and safety that is needed to confirm group of participants, while the drug being tested is given
efficacy and evaluate the overall benefit–risk relationship to another group. The results obtained in the two groups
of the drug and to provide an adequate basis for physician are then compared to see if the investigational treatment is
labeling. Note: Phase 3 studies usually include from several more effective than the placebo in treating the condition.
hundred to several thousand subjects.
Placebo effect: A physical or emotional change, occurring
Phase 3B: A subcategory of Phase 3 trials done near the after an inactive substance is taken or administered, that is
time of approval to elicit additional findings. Note: Dossier not the result of any special property of the substance. The
review may continue while associated Phase 3B trials are change may be beneficial, reflecting the expectations of the
conducted. These trials may be required as a condition of participant and, often, the expectations of the person giving
regulatory authority approval. the substance.

Phase 4: Postmarketing (Phase 4) studies to delineate Placebo non- responders: Non- responders on placebo
additional information about the drug’s risks, benefits, and define a group that would never improve their condition
optimal use that may be requested by regulatory authorities unless given the drug. They may be a group that, if we
in conjunction with marketing approval. NOTE: These could identify them, could be used to reduce clinical trial
studies could include, but would not be limited to, studying size. Using this group in a proof- of -concept, it may be
different doses or schedules of administration than were possible to test a drug even without a comparative placebo
used in Phase 2 studies, use of the drug in other patient and determine whether it is likely to be active.
populations or other stages of the disease, or use of the drug
over a longer period of time. Placebo responders: Most people think of the placebo
response as a true response. But much of it is actually
Phase 5: Postmarketing surveillance is sometimes referred regression to the mean. Clinical trial subjects with more
to as Phase 5. extreme symptoms are often selected because it is desirable
to see a dramatic effect upon treatment with the drug.
PHI: Protected Health Information.
Planned number of subjects: The number of subjects
PHS: Public Health System. planned to be enrolled for a clinical trial.

PI: Principal Investigator. Plasma derived medicinal product: A medicinal product
derived from human blood or human plasma.
PIP Addressee/Addressee of PIP Decision: The PIP
Addressee is the name given to the legal entity that P.O: Per orem or per os, which means by mouth.
has received the Agency’s decision on a Paediatric
Investigation Plan (PIP). Policy (agency): The set of rules, directives and guidelines
published by an individual Agency or jointly by the
PIP: See Pediatric Investigation Plan. Agencies (CIHR, NSERC & SSHRC).

Pivotal study: A study, usually Phase 3, which presents Population: Any finite or infinite collection of subjects
the data used by regulatory agencies to decide whether from which a sample is drawn for a study to obtain
to approve a drug. A pivotal study will generally be well- estimates for values that would be obtained if the entire
controlled, randomized, and whenever possible, double- population were sampled.

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