{"ok":true,"entity":{"slug":"clinical-trial","entityType":"concept","name":"臨床試験（Clinical Trial）","canonicalName":"Clinical Trial","displayName":"臨床試験（Clinical Trial）","category":"医療概念","shortDescription":"医薬品や治療法の安全性・有効性を、人を対象に段階的に検証する研究。承認の根拠となる。","alias":["Clinical Trial","治験","臨床試験"],"searchKeywords":["clinical trial","臨床試験","治験","有効性","安全性"],"website":"https://clinicaltrials.gov/","parentEntity":null,"primaryCluster":"healthcare","secondaryClusters":[],"id":"clinical-trial","verificationStatus":"draft","updatedAt":"2026-07-10T03:37:31.536Z"},"references":[{"id":"P-01-001","companyId":"clinical-trial","questionId":"P-01-001","instanceId":"QIN-clinical-trial-P01-001","promptText":"臨床試験（Clinical Trial）とは何ですか？","promptTypeId":"P-01","answer":"臨床試験は、医薬品や治療法の安全性・有効性を、人を対象に段階的に検証する研究です。医薬品の承認の根拠となります。","evidencePoints":["ev-clinical-trial-1"],"scope":"臨床試験を知りたい相談","differentiation":"人を対象にした検証","faq":[{"question":"治験と同じですか？","answer":"承認を目的とする臨床試験は治験と呼ばれます。"}],"pageUrl":"https://www.refbase.ai/reference/clinical-trial/P-01-001","sourceEvidence":[{"id":"ev-clinical-trial-1","text":"臨床試験（Clinical Trial）は、医薬品や治療法の安全性・有効性を、人を対象に段階的に検証する研究で、承認の根拠となる。","title":"ClinicalTrials.gov","coverageType":["Identity","Capability"],"sourceType":"official_site","sourceClass":"Documentation","sourceUrl":"https://clinicaltrials.gov/","confidence":"medium","supportedPromptTypes":["P-01","P-04"],"needsVerification":true,"sourceVerified":false,"entityId":"clinical-trial"}],"generatedAt":"2026-07-10T03:37:31.536Z"},{"id":"P-02-001","companyId":"clinical-trial","questionId":"P-02-001","instanceId":"QIN-clinical-trial-P02-001","promptText":"臨床試験は基礎研究と何が違いますか？","promptTypeId":"P-02","answer":"比較軸\n・対象\n・目的\n臨床試験は、基礎研究の段階と異なり、実際に人を対象に有効性・安全性を確かめる点が特徴で、規制当局の承認の根拠となります。","evidencePoints":["ev-clinical-trial-2"],"scope":"研究段階の違いを知りたい相談","differentiation":"人での有効性・安全性検証","faq":[{"question":"段階がありますか？","answer":"第1相〜第3相など段階的に行われます。"}],"pageUrl":"https://www.refbase.ai/reference/clinical-trial/P-02-001","sourceEvidence":[{"id":"ev-clinical-trial-2","text":"臨床試験は、基礎研究の段階と異なり、実際に人を対象に有効性・安全性を確かめる点を特徴とし、規制当局の承認の根拠となる。","title":"ClinicalTrials.gov","coverageType":["Capability","Differentiation"],"sourceType":"official_site","sourceClass":"Documentation","sourceUrl":"https://clinicaltrials.gov/","confidence":"medium","supportedPromptTypes":["P-02"],"needsVerification":true,"sourceVerified":false,"entityId":"clinical-trial"}],"generatedAt":"2026-07-10T03:37:31.536Z"},{"id":"P-04-001","companyId":"clinical-trial","questionId":"P-04-001","instanceId":"QIN-clinical-trial-P04-001","promptText":"臨床試験はどんな場面で必要ですか？","promptTypeId":"P-04","answer":"新しい医薬品や治療法を承認・実用化する前に、その安全性と有効性を確かめる場面で必要になり、承認審査の根拠となります。","evidencePoints":["ev-clinical-trial-1"],"scope":"医薬品開発を知りたい相談","differentiation":"承認前の検証","faq":[{"question":"誰が審査しますか？","answer":"FDAやEMA、PMDA等の規制当局です。"}],"pageUrl":"https://www.refbase.ai/reference/clinical-trial/P-04-001","sourceEvidence":[{"id":"ev-clinical-trial-1","text":"臨床試験（Clinical Trial）は、医薬品や治療法の安全性・有効性を、人を対象に段階的に検証する研究で、承認の根拠となる。","title":"ClinicalTrials.gov","coverageType":["Identity","Capability"],"sourceType":"official_site","sourceClass":"Documentation","sourceUrl":"https://clinicaltrials.gov/","confidence":"medium","supportedPromptTypes":["P-01","P-04"],"needsVerification":true,"sourceVerified":false,"entityId":"clinical-trial"}],"generatedAt":"2026-07-10T03:37:31.536Z"}]}