Clinical Trial Design
- Conducting a background review of published literature, previous studies and competing products to provide a sound basis for the design and sample size
- Advising on choice of design such as
- Parallel or crossover
- Superiority, non-inferiority or equivalence
- Defining the endpoints for efficacy and safety
- Identifying data to evaluate the endpoints
- Case report form development
- Validation of questionnaires
- Sample size calculations and power analyses
- Advice on value of interim analyses and sequential design
- Advice on clinical aspects
- Inclusion/exclusion criteria
- Allowed concomitant medications
- Clinical feasibility and relevance
- Writing the statistical analysis plan
- Discussions with regulatory authorities to ensure trial meets regulatory needs
Conduct of trial
- Safety monitoring
- Physician coverage
- Subject eligibility
- SAEs
- Ongoing risk benefit assessment
- Eligibility waivers
- Interim analysis/review
End of trial
- Blind data review
- Definition/management of protocol deviations
- Revision of statistical analysis plan
Reporting
- Review and interpretation of data
- Review of report
- Publication policy
- Interface with key opinion leaders
- Preparation or review of expert reports
