Figure 18: Follow the Signs to Cancer Prevention, Detection, Diagnosis, and Treatment. Biomarkers are defined as cellular,
biochemical, and molecular (including genetic and epigenetic) characteristics by which normal and/or abnormal processes can be
recognized and/or monitored. Biomarkers are measurable in biological materials such as tissues, cells, and/or bodily fluids. Depicted
are examples of biomarkers in clinical use to help assess an individual’s cancer risk, detect a growing cancer, make a cancer diagnosis,
identify those patients most likely to benefit from a specific molecularly targeted therapy, and modify treatment decisions.
science and policy, the FDA must have the resources to recruit
and retain highly qualified staff, as well as develop new tools
and techniques. They must also have the means to fully engage
with the broader scientific community in discussion about
areas of scientific progress so that the work of this important
agency will benefit from the latest advances in the field.
Likewise, these interactions also benefit the broader scientific
community by providing it with a better understanding of
regulatory policies, facilitating the translation of discoveries
into new and improved therapies.
Engaging Patients in
Clinical studies, particularly clinical trials, are a key component
of cancer research (see sidebar on The Virtuous Cycle
of Biomedical Research, p. 9) because they enable
researchers to demonstrate that therapies showing promise
in the laboratory are safe and effective for use in people.
Typically, researchers conduct randomized clinical trials
wherein experimental interventions are tested against the
current standard of cancer care in patients and, in some
cases, healthy volunteers. Although patient participation in