- As a study participant, will I have knowledge of the study medication
that I am taking?
The majority of studies are "double-blinded."
This means that neither the study patient nor the principal
investigator has knowledge of the drug that the patient has
been assigned to during the study. This assures objective interaction
on the part of the research staff and the study participant.
- What if I experience side effects that I feel are associated
with the study medication?
If you feel your are having problems with study medication,
you should contact the research office and speak with the study
coordinator who has been assigned to you during the study. If
a clinician feels you may be experiencing problems with the
study medication, it may need to be discontinued.
- What happens if I have a medical problem after hours or over
the weekend?
The research facility has a phone recording after hours
that will instruct study patients how to contact the on call
coordinator. There are back up personnel in the event that the
coordinator in not able to be reached.
- Will I receive payment for participation in the study?
Most studies will reimburse study participants for time.
All study related procedures such as physical exam, diagnostic
laboratory studies and study medication are free to study participants.
- What are the risks associated with participation in a study?
A study patient before any participation in the study signs
an informed consent. This "informed consent" will
describe any known side effects and risks associated with study
medication in addition to outlining any other procedures that
will be required during the course of the study.
- What is required of an individual if they choose to enter into
a study?
Patients involved in clinical drug trials are monitored
closely and therefore evaluated frequently. In the early phases
of a study, visits are more frequent perhaps once a month, however
as the study progresses and the patient is doing well visits
become less frequent. Laboratory studies and Electrocardiograms
are usually required. Study diaries capture information on side
effects, outside office visits and medication changes and need
to be maintained throughout the study. Thus, study participants
need to be motivated to complete the diary.
- How longs are study visits?
The initial visit usually is the longest. This visit may
be 1 to 2 hours. It is at this visit; informed consent is reviewed
with the patient along with an extensive medical history, physical
exam, laboratory studies and other diagnostic tests. Subsequent
visits are usually 20 to 30 minutes.
