How to Read an Abstract for a Clinical Trial
Publication
Research articles provide information about cancer research. There are many different types of cancer
research that are published in these articles, including clinical trials that evaluate potential new cancer
treatments. Research articles about clinical trials, whether these trials are ongoing or completed, can
provide information that may help you and your doctor when making treatment decisions. However, these
articles are typically geared toward doctors and scientific researchers, making it dicult for someone
without a scientific background to understand.
To help, this article will walk through how to read and interpret the abstract from a research article, or
scientific publication. The Common Terms Used in Cancer Research Articles tool defines the words bolded
throughout this article as well as other words that may appear in abstracts and research articles for
clinical trial results.
What is an abstract?
An abstract is a summary of the research. Abstracts may be published in a scientific journal at the start of
the full research article, or they may be used at scientific/medical meetings or other formal presentations
of research. The abstract generally contains the most relevant information from the clinical trial, allowing
readers to understand what was done and what was learned, at a glance.
When available, plain language summaries (PLS) are helpful resources for understanding cancer research
information. They describe clinical trials and their results in simplified language and by way of helpful
visual aids and infographics, making them easier to read and understand for people outside of the
scientific community. They may be available for abstracts or for full research articles. However, not all
abstracts and research articles include a PLS.
Below is a breakdown of the typical sections within an abstract about clinical trial results. One abstract
may differ from another in format or in the section names, but they generally include similar information.
Full research articles are often divided into similar sections, but they are longer and have more details.
BACKGROUND
Why was this study done? What is the research question?
METHODS
How was the study designed?
RESULTS
What were the findings of the study?
CONCLUSION
What do the findings mean? Why are they important?
Title of Research Article
Authors
ABSTRACT
FULL RESEARCH ARTICLE
Background
The Background section generally explains what was previously known about available treatments and
the disease being studied and what questions the research aims to answer. This section usually tells the
reader what cancer(s) and treatment(s) are being studied in the clinical trial. This section may also be
called Introduction or Purpose.
Methods
The Methods section generally describes how the clinical trial was designed, including what was
measured. Clinical trials measure endpoints. Some endpoints examine a treatment’s efficacy, or how
well it works, while others look at its safety and
tolerability by measuring adverse events or adverse
reactions (sometimes called side effects).
In many clinical trials, the researchers randomly assign the participants to different treatment groups
within the study. Assigning participants randomly can help balance the groups so that certain
characteristics of the participants that may impact the trial will exist more evenly between the groups.
The groups of participants make up what are known as the “arms” of the study, and the treatments
can differ between the arms. In a phase 3 clinical trial, participants typically receive either the therapy
being studied, a standard of care treatment (which is one of the best treatments already being used for
the specific cancer being studied), or standard of care in combination with an inactive substance (also
known as a placebo). Participants receiving the treatment under study are in the experimental arm (or
investigational arm), while those receiving a standard of care treatment with or without placebo are in
the comparator arm (or control group).
Treatments and endpoints vary based on the phase of the trial. For example, a phase 1 study often only
includes the treatment being studied, and the endpoints are typically focused on safety, to confirm if
further testing of the treatment can continue. As a result, abstracts for phase 1 and 2 trials might have
slightly different information from abstracts for phase 3 trials.
The Methods section also usually describes details of the clinical trial design. Trials might be described
as randomized, crossover, parallel, double-blind, or open-label. Read more about these terms in the
glossary. Researchers determine the clinical trial design based on the treatment effect they are studying
and the answers they seek.
Results
The Results section provides an explanation of the outcomes of the study. This section tells the reader
what was learned in the trial, including whether the study treatment was effective and any safety events
that were experienced by the participants.
In this section, researchers use statistical (mathematical) tests to compare the results of the treatments
being evaluated. These tests help determine whether any improvements that were seen happened
by chance or because of a real effect from the study treatment. Some terms often used in this section
include statistical significance, confi
dence interval, hazard ratio, and p-value. These statistical terms
are typically used by scientists, but you can ask your doctor, or other member of your healthcare team,
about any terms you would like explained more clearly, or you can use the Common Terms Used in
Cancer Research Articles tool to help guide you as you are reading an abstract or research article. You
may also find it helpful to see if there is a PLS available for the clinical trial, or you can jump ahead to the
Conclusion section, which discusses the key takeaways from the study.
Conclusion
The Conclusion section, sometimes called Discussion, summarizes what was learned from the clinical trial
and any future steps, such as suggestions for more research. This section explains what the results mean
in relation to the clinical trial’s goal, such as explaining whether the cancer treatment being studied had
a beneficial effect on the disease of the participants in the trial and was considered acceptably safe. It
may also explain how these results are important to the cancer community. This section may also include
the limitations of the study, which are weaknesses that may impact the outcome and conclusions of the
study. Some examples include limiting the age of the participants, excluding people with other diseases,
such as heart disease, etc. Study limitations are not often included in the abstract but rather in the full
research article text. Some studies may also have a separate limitations section.
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Understanding the latest in cancer research may help you make more informed testing and treatment
decisions alongside your cancer care team. Talk to your doctor or a member of your healthcare team if
you have any questions about cancer research. As mentioned, the Common Terms Used in Cancer
Research Articles tool has definitions for scientific terms used in abstracts and research articles and may
be a helpful resource to guide your reading.