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Department of Public Health Sciences

BMTRY724

BMTRY 724 : Design & Conduct of Clinical Trials

DESCRIPTION

This course is intended for medical researchers interested in the design and conduct of clinical trials. The course will familiarize students with clinical trials including study design, randomization, sample size estimation and issues in data analysis. At the completion of this course, students will have the tools to design their own studies and will have developed their skills in being a more critical reader of the medical literature. This course is designed primarily for the students in the Division of Biostatistics & Epidemiology; however, both clinical and basic science investigators can benefit from the course provided they have the required background in basic statistics.

TOPICS:

  • Type of Questions to Ask/Study Designs
  • Endpoints
  • Study Population/Types of Controls/Interventions
  • Recruitment/Enrollment/Randomization
  • Study Protocol
  • Sample Size/Power Estimation
  • Regulatory/ GCP Guidelines/ Informed Consent
  • Data Analysis Issues
  • Adverse Events and Safety Monitoring/ DSMBs
  • Data Collection/Case Report Forms
  • Data Analysis Issues – Missing Data
  • Economic Evaluations
  • Equivalence Studies
  • Multicenter Studies
  • Clustered Randomized Studies

PREREQUISITES AND OFFERINGS

BMTRY 700 or instructor consent.  Typically offered each year in the summer semester.

 
 
 

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