ADDING A STRATIFICATION FACTOR DURING THE STUDY

Discover how a Sponsor reached the overall balance amongst 2 arms by adding a stratification factor.

Read the case study!

SITUATION:

  • Phase III study randomized study comparing 2 drugs (Drug1 and Drug2) following chemotherapy in patients with newly diagnosed FLT3-mutated acute myeloid leukemia

  • Randomized study using a 1:1 minimization algorithm based on 6 stratification factors
  • Early result review and observation:
    • 187 patients randomized (94/drug1 : 93/drug2)
    • 27 patients identified with an important biomarker that could potentially impact the outcome
    • 10 events were observed among the 27 patients
    • Imbalance treatment allocation for those patients (10/drug1 : 17/drug2

SPONSOR’S REQUEST:
Integrate that biomarker as a stratification factor (replace or add stratification factor)

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ADDING A STRATIFICATION FACTOR DURING THE STUDY

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