Why Extracting Clinical Trial Eligibility Criteria Is Harder Than It Looks

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Clinical trial protocols contain eligibility criteria written for human readers, making automated extraction structurally complex and error-prone. Two key source documents exist — the full protocol and the trial registry entry — and they are not interchangeable, with the registry often omitting important qualifications found in the protocol. Inclusion and exclusion criteria must be kept as separate lists rather than merged with a polarity flag, since mechanically negating criteria containing internal negations can cause downstream rule engines to evaluate conditions incorrectly. Bundled criteria, where a single numbered item contains multiple evaluable conditions joined by 'and', must be split into atomic units to be reliably assessed against individual patients. Multi-arm trials add further complexity, as arm-specific criteria flattened into a single list produce a criteria set that no individual trial arm actually holds.

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