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Clinical Studies:
How Do They Work?
What Is a Clinical Study?
Research using human volunteers or “participants”
intended to add to medical knowledge.
Two types:
Clinical Trials Who Conducts?
Participants receive specific interventions according to the INVESTIGATOR
research plan or protocol created by the investigators, which Study is led by a principal investigator, often a medical
may include medical products, such as drugs or devices doctor.
procedures or changes to participants’ behavior.
RESEARCH TEAM
X May compare a new medical approach to a standard one Team may include doctors, nurses, social workers and
that is already available or to a placebo that contains no other health care professionals.
active ingredients or no intervention.
SPONSOR
X May compare two already-available interventions to
each other. Studies can be sponsored or funded by pharmaceutical
companies, academic medical centers, voluntary
X Investigators determine safety and efficacy by groups and other organizations, in addition to federal
measuring certain outcomes in the participants. When agencies such as the National Institutes of Health, the
a new product or approach is studied, it is not usually U.S. Department of Defense and the U.S. Department of
known whether it will be helpful, harmful or no different Veterans Affairs. Doctors, other health care providers
than available alternatives. and other individuals can also sponsor clinical research.
Some people who are not eligible to participate in a clinical trial may be able to get
experimental drugs or devices outside of a clinical trial. Who Participates?
Observational Studies Participants who have the illnesses or conditions that
Investigators assess health outcomes in groups of participants will be studied or participants. Some studies are limited
to a predetermined group of people.
who receive interventions, but participants are not assigned to
specific interventions by the investigator as they would be in a Who’s Eligible?
clinical trial.
The factors that allow someone to participate in a
Intervention Examples: clinical study are called inclusion criteria, and the factors
X Given medical products such as drugs or devices or that disqualify someone from participating are called
procedures as part of their routine medical care. exclusion criteria, and both criteria are listed in the study
X Observing a group of older adults to learn more about
the effects of different lifestyles on cardiac health.
4 HEMOPHILIA FEDERATION OF AMERICA < www.hemophiliafed.org