The state of the clinical trials system today.
This article describes the components, process, and regulatory requirements of the clinical trials system as well as the changes that have resulted from increased attention to patient safety. Also discussed are the economic and scientific pressures on pharmaceutical and medical device companies to run efficient clinical trials with rapid enrollment of subjects. The complexity of the clinical trials system and the demand for efficient trials that protect patients has led to the need for special training of physicians who conduct clinical trials. This year the first board examination for certified physician investigators will be offered through the Physician Investigator Certification Program of the American Academy of Pharmaceutical Physicians.
Kopecky
Stephen L
SL
Mayo Clinic and Mayo Medical School, USA.
Jopke
Terry
T
D002568:Certification; D002986:Clinical Trials as Topic; D006801:Humans; D008910:Minnesota; D012108:Research Personnel / Q000193:education*; D013044:Specialty Boards; D014481:United States