Understanding clinical studies and their relationship with biostatistics
Clinical studies are primarily used in two specific areas today: the pharmaceutical industry and medical research. Most drug development companies use clinical studies not just to evaluate present drugs but also to discover and develop new ones. The drug discovery process typically involves a series of clinical studies such as clinical trials to make sure that the drugs are safe and effective before they proceed to the medical industry areas.
Figure 10.1 – Clinical studies in the pharmaceutical industry and medicine
Regulations in many countries are a key aspect to consider. Very often, pharmaceutical companies conduct their own clinical studies such as Phase I to Phase IV clinical trials in compliance with regulatory frameworks of agencies such as the United States of America-based FDA (short for Food and Drug Administration; you may find more information on FDA at fda.gov...