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8 A Special Advertising Section of Baltimore Sun Media Group | Wednesday, February 22, 2023
RESEARCH
Understanding
clinical studies
How they work and how
you can get involved
By Margit B. Weisgal, Contributing Writer
Dr. Jeanine Werner
W
hat, exactly, is a clinical study? It is something that involves human
volunteers with the goal of adding to medical knowledge. There are two
basic types: clinical trials and observational studies. The goal of all stud-
ies is to “uncover better ways to treat, prevent, diagnose and understand human
disease,” according to the National Institutes of Health. Both types are included
in a searchable database at ClinicalTrials.gov (https://clinicaltrials.gov) along with
information on participating.
The National Institutes of Health
(www.nih.gov) encourages participation in clinical trials and studies. “It’s
your involvement,” it says, “that helps
researchers to ultimately uncover better
ways to treat, prevent, diagnose, and
understand human disease.”
Hundreds of thousands of clinical
studies are taking place around the world.
According to ClinicalTrials.gov, there are
currently “439,220 research studies in all
50 states and in 221 countries.”
ClinicalTrials.gov is a resource provided by the U.S. National Library of
Medicine (www.nlm.nih.gov) under the
aegis of the National Institutes of Health
(NIH). Anyone can access its database
and search for information on trials on a
variety of diseases and conditions, and
there is no need to register or provide
personal information.
Clinical trials, also called interventional studies, have four phases, starting small and involving a limited group
of participants, then gradually increasing those numbers. They usually involve
some type of intervention such as a new
medication or a new device. Alternatively,
the new drug, device or treatment is
compared to existing standards of care
to determine which is a more beneficial
solution for patients.
Observational studies look at specific population groups according to
a research plan or protocol. Many of
them last for years and have become
part of general knowledge, such as the
Framingham Heart Study, started in 1948
and now in its third generation. It transformed treatment of men with heart dis-
ease. The Nurses’ Health Study (I, II,
and III), started in 1976, has included
over 280,000 participants, investigating risk factors for chronic diseases in
women. The groundbreaking Women’s
Health Initiative studied strategies to prevent heart disease, breast and colorectal
cancer, and osteoporosis in more than
161,000 post-menopausal women aged
50-79 years.”
Participating in clinical trials
Jeanine L Werner, M.D., Maryland
Oncology Hematology, specializing in
breast and other cancers, has participated in many clinical trials that have
changed treatments for the better. Dr.
Werner practices oncology and hematology and is the recipient of the American
Society of Clinical Oncology (ASCO)
Merit Award. If she has a mantra, it’s that
she always has a personalized approach
because every patient is different. We
talked about the different types of trials
and getting patients involved.
“There are four phases to clinical trials,” Werner says, “and my patients and
I generally participate in phases 2 and 3,
looking at novel (new) compounds that
have promise and at what dosage. Phase
1 looks at toxicity, whether it is safe and
Dr. Luigi Ferrucci
if there are side effects. Phase 2 determines if it’s worth studying further for a
specific diagnosis. In Phase 3, we compare the existing standard treatment versus a new treatment or medication and
determine which works better, version A
or B. These are often double-blind studies, so participants don’t know which one
they are receiving.”
All patients go through a consent
process. “If they qualify, and that’s a very
specific determination,” explains Werner,
“then we discuss whether or not they
want to be involved. They should never
feel pressure from an investigator. It is
their choice, and they can stop at any
time. The patient is in the driver’s seat.”
Werner tries to offer the option of a
clinical trial as often as she can, but it’s
sometimes hard to find people who are
eligible due to the trial protocols. And,
depending on the circumstances, not all
patients are eligible for a clinical trial. For
instance, if a woman is pregnant, she can
be automatically excluded.
“When you’re dealing with someone
who has cancer,” Werner describes,
“you’re dealing with a person who is
Understanding clinical studies,
continued on page 28