Dr. Elliott Bennett-Guerrero and the Four Phases of Clinical Studies

By Elliott Bennett-Guerrero

Introduction

For more than 10 years, Elliott Bennett-Guerrero, MD, has lectured on anesthesiology and directed perioperative research at Duke University. In addition to these responsibilities, Elliott Bennett-Guerrero has overseen several clinical studies as a principal investigator.

Clinical studies are comprised of four testing levels that determine the approval or disapproval of a particular drug or treatment, with each stage answering a series of research questions. The following is a general summary of each phase:

Phases

Phase I —During the initial evaluation of the medicine or procedure’s safety, researchers utilize a small test group to determine a dosage range and discover any side effects.

Phase II —This period provides additional insight on safety and assesses the drug or treatment’s efficacy. Lasting up to several years, Phase II involves a larger number of participants.

Conclusion

Phase III —The third phase includes continued supervision of safety, efficacy, and any side effects. Further, researchers compare results to existing products and procedures.

Phase IV —Lastly, researchers conduct aftermarket observation to identify and issues linked to long-term use or involving certain populations segments.