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SITUATION:
- A randomized Phase III trial to evaluate the efficacy and safety of a new drug to treat critical limb ischemia
- A randomized phase 3 study using a 2:1 minimization algorithm (with 0.8 as the probability) balancing the patients according to minimization factors between 2 arms (Active and Placebo)
CHALLENGES
- The treatment is only manufactured if the patient is randomized to Active arm. Treatment is using the bone marrow of the patient.
- If the product cannot be manufactured or is damaged during the transportation, the randomized patient will not be treated.
=> This caused serious imbalance between the two randomized arms for the treated patient
IDDI biostatistics-driven RTSM helped the Sponsor to avoid serious imbalance between the two randomized arms for the treated patients.
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