Walk a feasibility decision before saying yes
Assess site feasibility by linking protocol-critical factors to real clinic capacity and evidence.
Feasibility pressure The sponsor wants 18 oncology participants in six months. Your clinic sees volume, but the protocol requires a biomarker, a washout period, central imaging, and weekly visits for cycle 1. A bad yes creates missed enrollment, rushed screening, protocol deviations, and participant burden. Quality by design Feasibility protects critical-to-quality factors Start with what must be true for participant safety and credible data, then test the site against those facts. Volume We see many patients, so we can enroll many participants. A smaller truthful target is higher quality than an impressive target built on assumptions. Quality starts at design…
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