Phases of a Clinical Trial

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Upon completion of this activity, learners will be able to:
Define a clinical trial and look at all phases of a clinical trial.
Identify the elements of phase II trials dealing with masking and randomization.
Recognize cohort and cross-sectional studies.

References
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https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
https://clinicaltrials.gov/ct2/resources/trends

Speaker(s): Jeannette Lee, PhD; Song Ounpraseuth, PhD; Page Moore, PhD

Dr. Lee is highly regarded for her work in the design and analysis of clinical trials of new and innovative medical treatments, particularly in the field of oncology. She received her doctorate in biostatistics from Johns Hopkins University and held positions at the Washington University School of Medicine in St. Louis.

Dr. Ounpraseuth is a Professor in the Department of Biostatistics of the Fay W. Boozman College of Public Health at the University of Arkansas for Medical Sciences (UAMS).  He is a Principal Investigator of the DCOC overseeing the statistical design, sample size estimation, and analytic plans for all ECHO ISPCTN clinical trials.  He interfaces directly with the NIH ECHO Program Office, the Data Safety and Monitoring Board (DSMB), and the Protocol Review Committee (PRC).  Currently, Dr. Ounpraseuth serves as the primary statistician on multiple ECHO ISPCTN protocols and participates in various writing groups.  He provides statistical support to researchers within the Network and participates in the NIH/DCOC/DCRI leadership meetings.  In addition to the activities of the ISPCTN, Dr. Ounpraseuth serves on various scientific review panels including DoD, PCORI, and NIH.  He currently serves as the primary statistical reviewer for the Journal of Ultrasound in Medicine and is an Associate Editor for BMC Health Services Research.

Dr. Moore previously worked in clinical trials in industry as a statistician. She also has served as a statistician on multiple clinical trials networks. Dr. Moore received her doctorate from Baylor University.