Course: Biostatistics for Medical Product Regulation

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Lecture Materials

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The posted lecture materials represent the visual component of the multimedia lecture presentations that are available to enrolled students. Students wishing to enroll in the for-credit version, which also includes faculty interaction and assessment, may visit the Biostatistics for Medical Product Regulation page on the JHSPH Distance Education site.

» Lecture 1: Biostatistics in Medical Product Regulation: Introduction ( Day )

  • Introduce the history of medical product regulation
  • Recognize examples of public health disasters that lead to regulation
  • Describe the process of product development

» Lecture 2: Study Designs, Objectives, Hypotheses (Foulkes)

  • Visualize a variety of study designs
  • Distinguish the categories of trials
  • Identify phases by differences in objectives

» Lecture 3: Study Populations (Day)

  • Describe the study population
  • Visualize the funneling of the recruitment process
  • Distinguish to whom study results apply

» Lecture 4: Study Designs (Day)

  • Distinguish and critique various methods of randomization
  • Explore the effects of randomization
  • Characterize good allocation schemes

» Lecture 5: Comparison/Control Groups (Foulkes)

  • Explore the range of possible control groups
  • Describe the purpose of control groups
  • Distinguish and critique the use of placebos

» Lecture 6: Outcomes, Surrogates, Composite Endpoints (Day)

  • Constrast various outcome measures
  • Understand the distinction between a surrogate and clinical endpoint
  • Visualize clinical and surrogate endpoints along a causal pathway

» Lecture 7: Analysis Issues, ITT, Post-Hoc, and Subgroups (Day)

  • Introduce various analysis issues
  • Contrast choices of analysis populations, including �intention to treat�
  • Explain the limitations of subgroup and post hoc analyses

» Lecture 8: Multiplicity, Missing Data (Foulkes)

  • Characterize the analytic dilemma of missing data
  • Describe various analytic methods, their limitations and assumptions
  • Identify the occurrence of multiplicity within trials
  • Introduce various analytic approaches to multiplicity

» Lecture 9: Non-Inferiority Specification of Delta (Foulkes)

  • Introduce the concept of non-inferiority
  • Discuss the issues of assay sensitivity and "bio-creep"
  • Formulate the delta or difference that defines inferiority

» Lecture 10: Multi-Regional Studies and Bridging Studies (Day)

  • Characterize multi-regional trials
  • Explain the need for multi-regional trials
  • Distinguish when bridging studies are needed
  • Describe the inferences from bridging studies

» Lecture 11: Interim Monitoring (Foulkes)

  • Link the need for a data monitoring committee (DMC) to the nature of the study population and the risks of the intervention
  • Describe the composition of the data monitoring committee
  • Contrast the data monitoring committee with others monitoring study conduct and subject safety
  • Discuss operational aspects of interim monitoring

» Lecture 12: Course Summary and Review (Foulkes)

  • Review the complete course content
  • Compare and contrast the existing regulations
  • Forecast applications of these concepts to future medical product development