Biomedical Engineering Reference
In-Depth Information
CHAPTER 2
The Clinical Perspective
Lee Bronfman, Craig D. Shriver, and Emily Gutchell
2.1
Introduction
Biomedical informatics research begins with clinical questions: How can the growth
of a tumor be stopped? How do certain diseases metastasize? Is there a less invasive
way than surgical biopsy to determine the presence of breast cancer? The questions
begin broadly and become very specific: Which women at high risk of developing
breast cancer will benefit from the use of tamoxifen and which will not? What is the
optimal combination of chemotherapy for a breast cancer that has metastasized to
the bones? Why does Herceptin work for some breast cancer patients but not
others?
It is within the clinical setting that the need for biomedical research is revealed,
and to this setting that the advancements of biomedical research return. No one
truly needs to be convinced of the need for clinical research. There is intrinsic agree-
ment that as human beings we have extraordinary needs for quality health care.
Although debates ensue regarding how research is conducted, it is rarely debated
that research is an essential enterprise and that it should be conducted with the high-
est level of integrity. A research project that meets the highest standards will begin
with a well-devised plan for launching the project from the clinical setting. In the
competitive biomedical informatics research environment of today, a successful
research project integrates the normal flow of clinical processes with the unique
demands of research. Health care clinics conducting biomedical research are likely
to be busy, with thousands of patient visits a year. Clinical research staff must
accomplish their work within the normal clinic business of the day, which poses
many challenges. A biomedical research project that is well integrated at the health
care clinic setting exhibits the following qualities:
Clinicians and clinic staff are well oriented to the goals of the research.
Clinic staff are well trained in the processes related to the research.
The actions of leadership support the research mission.
An organized, well-documented process is followed to obtain a patient's
informed consent to participate in research.
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