Overview of Clinical Research
Clinical research is the process of utilizing human subjects to answer important scientific questions such as:
- What features always characterize a disease?
- Can we use one or more of these features to make a diagnostic test?
- Do variations in the clinical features between patients mean that the patients' outcomes will be different?
- What drugs or other interventions are effective against this disease? The process of utilizing human subjects to answer research questions is challenging from several perspectives.
First, we must guarantee the safety of our subjects above all other considerations, so safety features are a formal part of every study design.
Second, there is a lot of normal variability between people for any characteristic we might look at, from eye color to the presenting symptoms of Alzheimer's disease. We have to decide which variations are normal and meaningless, and which variations might be important and affect the course of the disease.
Finally, the analysis of human subjects data is far more complex than the analysis of laboratory experiments because several factors must be examined at the same time. For example, if we want to know whether a new drug slows the progression of a disease, we have to mathematically “control for” how advanced each patient was at the start of the study. Clinical research in Alzheimer's disease therefore calls for the concerted efforts of a team of expert individuals.