Background, One of the responsibilities of the dental profession is to prot
ect and advance the well-being of the public through research of new pharma
ceuticals and devices. The objective of this article is to present informat
ion about the scientific and regulatory process involved in the design and
execution of randomized clinical trials.
Conclusions, Dentists willing to serve as investigators in clinical trials-
from Phase 1 to Phase 2 or Phase 3-need to be aware of the two main documen
ts that contain the majority of guidelines and regulations governing clinic
al research: Title 21 of the U.S.Code of Federal Regulations and the guidel
ines for good clinical practice put forth by the International Conference o
n Harmonisation.
Clinical Implications, Advancements in the frontiers of oral health science
and the development of safe, innovative and effective treatment modalities
are often the result of high-quality clinical research that is conducted b
y dental professionals. Knowledge of the research process, professionalism,
scientific integrity and a detailed execution of the research plan are all
required elements for a successful outcome.