Fancy statistical methods cannot rescue poor design. Many issues must be considered when designing clinical trials, the major is which study endpoints should be Selected. It is a responsibility of those who design and conduct trials to choose endpoints which will convince decision-makers such as clinicians and policymakers.
Generally, a single end point is limited to capturing the effect of an intervention, so multiple endpoints are usually selected and categorized as primary and secondary endpoints.
A wide variety of endpoints are used in clinical trials:
In cases where there is more control over endpoint selection, the following considerations are important and have been demonstrated to reduce sample size by 10% to 50% and greatly increase the power for statistical testing:
Additional methods for increasing your chances for a successful trial, with fewer resources include:
Specifying matched subject designs
Designing single arm trial for regulatory approval
Reducing “noise” by both appropriate measurements and statistical analysis
All the methods described above, used in combination or alone, will increase your trial’s efficiency while reducing costs and increasing the probability of success.
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