Every caregiver hopes for a miracle for their
loved one with Parkinsonís disease. The promise
of new drugs or therapies making a difference is
exciting. A caregiver may encourage their
loved one to take the jump and become part of a
clinical trial, in hopes of seeing a positive
outcome. The decision, however, is ultimately
left to the person living with the disease. A
caregiver can learn the facts, discuss options
and weigh the pros and cons, being a source of
information and support. Finding the study is
the easy part; thousands are conducted every
year. The decision of whether to participate or
not is more complicated.
What is a Clinical Trial?
Clinical trials are carefully designed research
studies that evaluate new treatments for
diseases. The purpose of a trial is to test the
safety and results of medications or treatments
not yet available to the general public. They
are regulated by the Food and Drug
Administration (FDA) and overseen by science and
medical experts, who ensure the trials are safe
and designed appropriately.
There are phases to a study, so each medication
or treatment is not evaluated just once and then
considered safe for use. Phase I is a study
typically done on 20-80 healthy people, to
establish how the medication, for example,
metabolizes and the reactions of different
Phase II trials further define the safety of the
therapies and are usually conducted on a larger
amount of participants, 100-300 people.
Phase III is where a current patient will be
introduced into the study. These are longer,
more involved trials, with even larger
populations of participants (1,000-3,000). Many
of these are known as ďdouble-blindĒ studies,
and determine the actual benefit of the
treatment to the patient and whether the
benefits outweigh the risks.
Finally, if the treatment is successful in all
previous mentioned phases, it is up for approval
from the FDA. Phase IV trials test the effect of
different dosages in patients and give a good
look at long-term effects.
Federal guidelines state that each participant
in a clinical trial must be given very in-depth
information about the trial before agreeing to
participate. Legally, this is known as ďinformed
consent.Ē The studyís staff will tell a
caregiver and loved one about the purpose and
length of the study, benefits and risks,
confidentiality and more. Itís a long
process, completing the informed consent, but
trial administrators need to ensure each
participant is doing so voluntarily, with
complete awareness of what to expect. Both
caregiver and loved one should know that
informed consent is NOT a contract and the
person can withdraw from the study at any time.
Pros and Cons
Many people enjoy participation in clinical
trials because they feel compelled to the
greater good. They believe this trial could help
them and also those who will be diagnosed with
Parkinsonís in the future. They realize that the
medications and treatments available to them
currently are only because others volunteered
for previous clinical trials.
In addition, there is a great benefit to being
treated by leading health care professionals. A
loved one will be surrounded by the cutting-edge
new treatments, at no cost. They will gain
knowledge and understanding about Parkinsonís in
general and how their body responds to
Being a part of a clinical trial can change the
schedule of a loved one and most likely, a
caregiver too. Depending on the nature of the
trial, a loved one with Parkinsonís may need
extra help with transportation to and from
multiple appointments. A trial participant
still works with their primary medical provider
as well as the study team. It is a great
opportunity to learn and receive care many
others with the same disease will not have
A Caregiverís Role in a Clinical Trial
Communicating During the Study
When your loved one is a study participant,
communication is essential. Make sure to talk
often about their feelings throughout the study.
Be aware of what your loved one is thinking and
feeling. You should discuss feelings when
they arise, while appreciating the need for
personal privacy. Remember to always
respect your loved oneís ability to make their
Recognize that negative emotions can arise for
both you and your loved one. It is OK for either
of you to feel sad or frustrated. Expressing
these emotions is, in fact, healthy and normal.
Other ways to keep communication flowing
Encourage your loved one to keep a journal. You
can also discuss your loved oneís diary entries
for the study or help your loved one to fill out
Set aside time each day or week to talk about
the most recent study visit.
Learn basic relaxation techniques to keep
tension and stress low.
Supporting Your Loved One
Those who participate in clinical trials must be
sure to take the study medication as prescribed.
If the instructions are not followed correctly,
doses are missed, or study medications run out,
then the research results could be negatively
affected. It could even affect the health of
your loved one. It also undermines the
very reasons your loved one volunteered for the
Seek advice on how to organize your loved oneís
Create a system to ensure study medication has
If using a weekly pill organizer, include the
study medication for each day.
Make sure refills are received at each
Donít let your loved one skip an appointment
because they could run out of study medication.
Clinical trials are an essential part of medical
advancements and these advancements only come
when people step up to participate. Being a part
of a clinical trial can take extra time and
effort for both caregiver and loved one.
The key is to finding a trial that is attainable
and encourages that sense of purpose a person,
especially someone with a debilitating disease,
hopes to have. Parkinsonís slowly may be taking
away independence, but knowing that they can
still make a difference for themselves and
others may be just the positive reinforcement a
loved one needs.
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