Chapter 1
Clinical Research Basics
To get just one new drug from the initial “Aha!” moment in
the laboratory into the hands of people with Parkinson’s can
take several decades, billions of dollars, and thousands of
volunteers, researchers and doctors. Even before a therapy
can be tested in people, years of basic and pre-clinical
research must prove that it has the potential to work and is
safe. And the odds are stacked against therapies making it
through this thorough vetting.
So, when drugs do “graduate” to being tested
in people, it’s reason for cautious celebration.
Clinical trials and studies are a final and crucial
step on the path to developing better treatments
for Parkinson’s. They also are an opportunity for
volunteers to step forward. New therapies can move
toward approved use only with the participation of
people with Parkinson’s.
The Michael J. Fox Foundation supports early-stage
testing of new therapies and addresses systemic
challenges in the drug approval process so that
more Parkinson’s drugs can cross the finish line
faster. But while financial investment is important
to accelerate research, it’s research volunteers
who give us the best chances of understanding
this disease and finding a cure. In the 200 years
since Parkinson’s disease (PD) was initially
described, researchers have made significant gains
in knowledge of Parkinson’s — recognizing the
non-motor symptoms, such as mood and memory
problems, that can accompany PD and realizing
Parkinson’s genetic connections, for example. These
understandings have shifted care and research,
and none of this progress would have been possible
without clinical trials and volunteers.
By participating in clinical research, you give
something money can’t buy. Funding and other
resources can’t make up for a lack of volunteers —
an issue many clinical studies grapple with. Across
all research, 85 percent of trials face delays, and
30 percent never even get off the ground. This
dramatically slows research progress.
You can be an agent of change by taking a
more active role in your own health care and
contributing to Parkinson’s research. You have
the power to propel clinical research toward
breakthroughs that help people with Parkinson’s
in their everyday lives. You could be the key that
unlocks a cure.
In this chapter, you’ll learn the basics of clinical
trials and studies: how researchers conduct them,
who can volunteer, and what their potential risks
and benefits are. You’ll also find information on
how to connect with trials and studies and talk
to your doctor about research, as well as what to
consider when deciding if and how to participate.
Chapter 1 — Clinical Research Basics
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