Adaptive Population Enrichment Trial Design in Confirmatory Stage of Acute Coronary Syndrome Treatment's Development

The Medicines Company is developing a treatment for an acute coronary ailment characterized by low event rates and diverse patient populations.

Response – Mitigate late stage development risk, gain label flexibility with a Cytel adaptive trial design

Cytel designs an adaptive confirmatory trial with interim analyses first to consider stopping early, then sample size re-estimation and population enrichment.

The “two trials in one” approach reduces The Medicines Company’s exposure to nuisance parameters – population and recruitment uncertainties – that could slow research efforts and jeopardize continued supporting funding.

The result is multiple sub-population approval scenarios – a clinical strategy far less risky than conventional “all or nothing” studies.

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