March 7, 2012

Choosing Appropriate Methods


  • Does the study design enable the investigator to address the aims and hypotheses?
  • What might go wrong? What alternative strategies would you turn to if something went wrong?
  • What are the expected outcomes and why are they important?
  • How will you assess statistical significance?
  • How many subjects will you need? How did you derive that number?
  • What are the controls? Have you addressed potential sources of bias?

Basic science approach:

  1. Approach
  2. Overview of methods
  3. Essential reagents needed
  4. Critical equipment required
  5. Number of subjects/animals and how they were derived
  6. Statistical analysis
  7. Controls
  8. Replicates
  9. Detailed expectations
  10. How results will be interpreted
  11. Time required to complete
  12. Expected outcomes
  13. Potential problems and alternative strategies (if working hypothesis proves invalid)
  14. Timeline
  15. Future directions


Clinical science approach:

  1. Study design and protocol overview
  2. Study environment
  3. Participant recruitment
  4. Inclusion criteria
  5. Exclusion criteria
  6. Eligibility screening, enrollment, and randomization
  7. Description of intervention
  8. Interim monitoring
  9. Data collection schedule and procedures
  10. Data analysis plan
  11. Sample size consideration
  12. Missing data
  13. Data management
  14. Team communication and project management
  15. Timeline
  16. Limitations

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