The OPRC Program is conducting different types of studies to learn more
about how medications and supplements are processed by the body during
pregnancy. Below is a short description of common research terminology,
including each type of study.
Basic/Translational Research: This term refers to research that
does not involve human research participants, but whose purpose is to
increase understanding of a disease or condition in order to promote
research in humans. Examples are animal studies, studies involving
cells, and computational and system modeling.
Opportunistic Study: The term “opportunistic” in study design
refers to adding a research goal to an intervention that is already
being conducted as standard of care. For instance, an example would be
drawing blood from a pregnant woman who is already being prescribed a
medication by her care provider, for the purpose of studying its
pharmacokinetic/pharmacodynamics.
Pharmacodynamics (PD): Often conducted in tandem with
pharmacokinetics during a Phase I or II study, PD is the study of what
the drug does to the body. More complexly put, PD is the relationship
between the concentration of the drug in the body and the biological or
physiological effects of the drug on the body or on other organisms in
the body (such as bacteria).
Pharmacokinetics (PK): Often conducted in tandem with
pharmacodynamics during a Phase I or II study, PK is the study of what
the body does to the drug. Commonly studied measures are how fast and
how completely the drug is absorbed into the body, how the drug is
distributed throughout the body, to what extent the drug is metabolized,
and how rapidly the drug is eliminated from the body.
Phase I: These are small, short-term studies who primary purpose
is to assess the safety of a drug. Phase I studies are typically
conducted with healthy volunteers, though patients with the medical
condition under study are sometimes recruited. In OPRC studies, a Phase I
trial may include pregnant women who are already being prescribed the
medication by their care provider. The goal is to determine the drug’s
most frequent and serious adverse effects, and often, how the drug is
metabolized and excreted. These studies usually have 20 to 100 study
participants.
Phase II: These are studies that gather preliminary data on
optimal dosing and effectiveness (whether the drug works in people who
have a certain disease or condition), often comparing the drug to a
placebo or alternate treatment. These studies also gather additional
safety and adverse effects information and usually have up to several
hundred study participants.
Phase III: These are larger studies (several hundred to several
thousand study participants) that continue to obtain information about
safety and effectiveness of the study drug by comparing the drug to a
placebo or alternate treatment.
Phase IV: These are studies typically conducted after the drug
has received market approval to gather information on the drug's effect
in various populations and any safety effects associated with long-term
use.
Pilot Study: These studies are smaller in scale, primarily
conducted to evaluate feasibility, time, cost, and adverse effects. This
preliminary data can be used to determine sample size and the
appropriate study design prior to conducting a full-scale research
study.