March 7, 2012
Choosing Appropriate Methods
- Biostatistics vs. lab research
- Good Study Design and Analysis Plans as Features of Ethical Research with Humans
- Working with statisticians
- 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:
- Overview of methods
- Essential reagents needed
- Critical equipment required
- Number of subjects/animals and how they were derived
- Statistical analysis
- Detailed expectations
- How results will be interpreted
- Time required to complete
- Expected outcomes
- Potential problems and alternative strategies (if working hypothesis proves invalid)
- Future directions
Clinical science approach:
- Study design and protocol overview
- Study environment
- Participant recruitment
- Inclusion criteria
- Exclusion criteria
- Eligibility screening, enrollment, and randomization
- Description of intervention
- Interim monitoring
- Data collection schedule and procedures
- Data analysis plan
- Sample size consideration
- Missing data
- Data management
- Team communication and project management