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October 15 – 21, 2021

Reply To: biomarkers as stratification factors Elise Kohn

Forums Topic Group 1 biomarkers as stratification factors Reply To: biomarkers as stratification factors

#1140
Elise Kohn
Participant

I agree, validated biomarkers should be incorporated as relevant to the trial design, whether prognostic or predictive.  But, we should be thoughtful in the number, as stratification factors “cost” in statistical design.

Collecting such information as associated data, not using for eligibility or stratification (if not pertinent to design), should be encouraged so that we have the broadest view of the trial participant population.

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