The fundamental components of clinical trials and the nuances of how these components are implemented in clinical trials investigating therapies for CD or UC were explored in the Introduction to Clinical Trial Design e-zine (US-VED-1472).
As a reminder, multiple, sequential clinical trials are often required to establish the efficacy and safety of the induction and maintenance dosing of CD and UC investigational therapies.[1,2,3]
The endpoints for these trials are defined using validated instruments that incorporate both quantitative measures and patient-reported outcomes (PROs) to evaluate the efficacy and safety of the investigational therapy.[4,5]
Additional factors, which complicate the design of CD and UC clinical trials, included:[6]
Condition heterogeneity
Prior therapies
Enrollment complications
Sample size requirements
Placebo effects
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Summary of the Clinical Trial Primer
The fundamental components of clinical trials and the nuances of how these components are implemented in clinical trials investigating therapies for CD or UC were explored in the Introduction to Clinical Trial Design e-zine (US-VED-1472).
As a reminder, multiple, sequential clinical trials are often required to establish the efficacy and safety of the induction and maintenance dosing of CD and UC investigational therapies.[1,2,3]
The endpoints for these trials are defined using validated instruments that incorporate both quantitative measures and patient-reported outcomes (PROs) to evaluate the efficacy and safety of the investigational therapy.[4,5]
Additional factors, which complicate the design of CD and UC clinical trials, included:[6]
Condition heterogeneity
Prior therapies
Enrollment complications
Sample size requirements
Placebo effects
Select the next wheel stop to continue.
Summary of the Clinical Trial Primer
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