Research
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A clinical trial is a research study designed to answer basic and clinically
relevant questions about a new treatment or a new way of using an old
treatment. A clinical trial provides information or data by which treatments
can be measured – how effective they are (efficacy) and how safe they are
(side effects).
Clinical trials are incredibly important for determining new and more
effective treatments. They require voluntary participation and that each
participant is fully informed about the details of the clinical trial before
enrollment. Safeguards are required to ensure that each clinical trial is
scientifically valid, has fair subject selection, a favorable risk-benefit ratio
and ensures the respect and safety of all those enrolled.
While participating in a clinical trial can be time-consuming, the results can
be potentially groundbreaking. Many of the cancer treatments we take for
granted today were, at some point, studied in a clinical trial. Patients and
physicians must discuss and evaluate all associated factors before deciding
a course of action as there are always risks associated with any form of
treatment. Patients typically choose to participate in clinical trials because
they are looking for availability and access to new treatments that may be
effective for them when other treatment methods have proved unsuccessful
or limiting.
The medications used to treat cutaneous lymphoma are evaluated in three
ways: formal clinical trials, years of post-marketing experience and case
studies. In the medical literature, over the last decade, evidence-based
criteria have been used for evaluating the quality and impact of published
data that demonstrates a particular treatment’s effectiveness. This
information is published and made available for use by doctors, researchers
and patients.
The best evidence for evaluating whether a treatment is effective for
cutaneous lymphoma is a controlled clinical trial in which a new drug is
directly compared to another, usually older, drug (the control). The best
Chapter 17
Clinical Trials
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Part
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