ARTICLES / General /Clinical
Trial Rundown /
By Jennifer Bradley, Staff Writer
Every caregiver hopes for a miracle for their
loved one with Parkinson’s 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 “double-blind” 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 “informed
consent.” The study’s staff will tell a
caregiver and loved one about the purpose and
length of the study, benefits and risks,
confidentiality and more. It’s 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.