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What is a Clinical Research Study?
A clinical research study,
also called clinical trial or medical research, is a scientific
process designed to test the effects of an investigational new
medication or treatment in a group of volunteers. The information
from clinical studies helps researchers determine if a new medication
is effective, safe to use, and if there are any side effects.
What is Informed Consent?
Informed consent is the process
of learning the key facts about
a clinical trial before deciding
whether or not to participate.
It is also a continuing process throughout the study to provide
information for participants.
Risks and potential benefits
are
explained in an “Informed consent
form”. Informed consent is not a contract, and the participant
may withdraw from the trial
at any time.
Who Can Participate in a Clinical
study?
Each clinical study has different
requirements for patient enrollment such as age, sex or medical
condition. People respond differently to medicines and other treatments
so it is important to include men and women from different races.
The research team will look at your medical history and determine
if you are eligible based on the study requirements.
What Can I Expect as a Study Volunteer?
During study visits, the research
staff will review your medical history, provide information about
the study medication, explain the study procedures and monitor
your health. Some clinical studies may involve tests such as
EKGs or lab tests. All study-related medical exams, laboratory
tests, and study medication will be provided at no cost.
Why Should I Volunteer?
Participation in clinical trials
allow patients to gain access to new medications and treatments
before they are widely available, obtain expert medical care
at leading health care facilities and most of all, help others
by contributing to medical research.
How Can I Participate
in a Study?
If you are interested, talk
to your doctor or healthcare
provider to see if a clinical research study is right for you.
Patient recruitment is sometimes advertised
in the newspaper or on the
TV or radio. To learn more about being
in a clinical research
study, visit
http://www.clinicaltrials.gov
ClinExcel Research conducts
headache research
studies. For more information,
Call (513) 777-2543
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