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Table 1 Key elements, requirements and additional benefits of multiplex trial design

From: More ethical and more efficient clinical research: multiplex trial design

Key elements
A Clinical equipoise between treatment arms
B Factorial design allows simultaneous participation in multiple subtrials
C Continuous design so subtrials are embedded in a permanent infrastructure
D Broad inclusion criteria
E Relevant and robust outcome measures according to GRADE
F Large sample sizes
Requirements
Treatment arms reflect current practice (A)
Increased involvement of patients (B)
Streamlined consent procedure for multiple subtrials (B)
Multiple principal investigators must closely collaborate (B)
Mutual acceptance of multiple sponsors (B)
Extensive involvement of institutional review board (A,B,C)
Integration with existing outcome registries (C,E,F)
Advanced ICT infrastructure (B,C)
Benefits
Patients More confidence in clinical research (A,B,E)
Scientific Detection of interactions (B)
  Results with low risks of bias (A,D,E,F)
  Results with low risks of random error (A,D,E,F)
  Higher external validity (C,D,F)
Societal More answers to relevant clinical questions (B,C,D,E,F)
  More efficient use of resources (B,C,D)
  1. Summary of the components of the multiplex concept (A through F) and the various requirements as well as further benefits that we foresee that are related with these components.