about your ongoing medical and
Parkinson’s care. You can and should
continue seeing your regular health
care providers and, if possible, they
should coordinate with the trial team
so that they are kept up to date on your
involvement. It’s especially important
for your Parkinson’s doctor to know if
and how your PD medications will be
adjusted while you are in the trial. And
if you undergo tests and receive the
results, your regular physicians may
want to see them as well.
16
trial — typically are not covered by
insurance but are covered by the study
funder. Costs related to problems that
might develop during a research study
are handled differently from study
to study. Coverage and cost are good
topics to go over in depth with your
insurance provider and trial team.
+ + What about medications I take or
other conditions I live with?
Trial protocols and inclusion and
exclusion criteria take medications
and medical conditions into account
so that the right people are selected
for the right trials. A certain medical
condition, such as memory loss, could
make you ineligible for one trial but
make you the exact type of participant
needed in another. Researchers
carefully consider all medical
conditions, such as high blood pressure
or heart disease, and medications
taken for them. They will exclude you
from participating in a trial if doing
so would create too great of a risk for
you. Trial teams also won’t adjust
non-Parkinson’s medications during a
study. However, your PD drugs might
need to be changed as part of a trial.
It’s worth discussing this ahead of time
with your Parkinson’s doctor. + + What if I get a placebo?
Some people volunteer for clinical
trials in hopes of receiving a new
drug. Unfortunately, you don’t get to
choose the group you are randomized
in. (Assigning participants through
randomization ensures the treatment
and placebo groups are similar, which
means the science and math behind
the study are stronger.) The potential
benefits and risks of new therapies
need to be measured against the
benefits and risks of not getting
them (i.e., getting a placebo). The
people who take placebo in trials
serve an extremely important role.
They help researchers ensure any
effects — good or bad — are from
the treatment and not another factor.
Placebo-controlled trials give the
highest level of scientific evidence
for (or against) therapies in clinical
research. Ask what the chances are
of getting placebo. In many trials, it’s
not 50:50, and more people may get
the investigational treatment than
the placebo.
+ + What about insurance coverage
and costs?
There are two types of costs associated
with a clinical trial: standard patient
care and research. Standard patient
care costs are those related to treating
your Parkinson’s, whether you are in a
trial or not. These include doctor visits,
medication, and lab and imaging tests.
Health insurance providers often cover
these, but you may want to check with
your insurer to determine the extent of
your coverage. Research costs — the
study drug and labs and imaging or
other tests performed solely for the + + What if I want to quit?
You’re a volunteer, which means that,
although ideally you remain enrolled
until the study’s completion, you can
leave at any time. Life circumstances,
changes in health or other factors may
contribute to a participant’s decision
to leave a trial. This is permissible at
any time. To officially withdraw from
a study, you would inform the trial
team and follow a specific protocol.
Sometimes it is still possible to
continue in a study even if you stop the
study drug, which helps researchers
continue to collect valuable data.
Navigating Clinical Trials: A Guide for Parkinson’s Patients and Families
+ + How should I decide whether
to volunteer?
Ultimately, the choice to get involved
in research is yours. But it’s not one
that should be made in isolation. Get
perspectives from those you trust,
including your care partner, family
members and doctor. Make sure the
trial team answers all your questions,
so that you can make an informed
decision. Consider these questions for
specific trials:
+ + What is the goal of this study?
+ + What is the exact intervention? For
example, if it’s a medication, how many
times per day will I need to take pills?
+ + What are the potential benefits and
risks? How do these compare to the
treatment I am currently taking?
+ + In an interventional trial, what are
the chances I will be assigned to the
placebo group?
+ + What types of side effects might I
experience?
+ + How could the study affect my daily
life? How often will I need to meet
the study team and how long will the
visits last?
+ + Where and when will testing occur?
+ + What type of information will
be collected?
+ + Will a care partner or other person
need to accompany me to on-site visits?
+ + Will I have to stay in the hospital?
+ + Will my expenses be covered?
+ + How long will the study last?
+ + Will I need to stop taking my
Parkinson’s medication or change
my dosage?
+ + If the treatment works for me, can I
continue it after the trial?
+ + What happens if I no longer wish
to participate?
You will most likely think of many
more questions that are unique to your
situation or trial. Take the time to get the
information you need so that you feel
secure with your decision to take part in
Parkinson’s research.