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Table 3 Co-enrollment decision-making grid

From: Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial

  Impact of co-enrollment Trial A Trial B
Scientific integrity
  1. Population of concern Overlap?   
  2. Enrollment window Which closes first?   
  3. Timing of intervention Overlap?   
  4. Study period Overlap?   
  5. Exclusion criteria Conflict?   
 Overlapping endpoints
  6. Primary endpoint Overlap?   
Potential impact?
  7. Secondary and exploratory endpoints Overlap?   
Potential impact?
  8. Magnitude of interaction Known/unknown?   
Dilution/enhancement of effect?
  9. Level of randomization Same/different?   
  10. Timing of randomization Same/different?   
  11. Potential of imbalance Yes/no?   
  12. Effect of co-enrollment Contamination?   
Data interpretation
  13. Power to determine interactions Sufficient/insufficient?   
  14. Attribution of adverse events Easy/difficult?   
  15. Parent/legal guardian burden Yes/no?   
  16. Site investigator burden Yes/no?   
  17. Bedside clinical team burden Yes/no?   
  18. Current sharing scheme Yes/no?   
Additional considerations
  19. Impact on publication Known/unknown?   
  20. Intervention use off-protocol Yes/no?   
  21. Priority High/low?   
  22. Possible sharing arrangement