{"bundle_type":"pith_open_graph_bundle","bundle_version":"1.0","pith_number":"pith:2016:XKGDC76ANRAESOAUSSTYRQAG6B","short_pith_number":"pith:XKGDC76A","canonical_record":{"source":{"id":"1607.00046","kind":"arxiv","version":1},"metadata":{"license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2016-06-30T21:03:40Z","cross_cats_sorted":[],"title_canon_sha256":"1ef488aacd6009661c7c7368544ee84e3b8ee9197be43d877f123f79105eeb50","abstract_canon_sha256":"abe89c72df2d93c92bcaffecebfb3204715eca27d51789f131757fe4ad5dd32a"},"schema_version":"1.0"},"canonical_sha256":"ba8c317fc06c4049381494a788c006f05a054758440e422050cbb533219f7982","source":{"kind":"arxiv","id":"1607.00046","version":1},"source_aliases":[{"alias_kind":"arxiv","alias_value":"1607.00046","created_at":"2026-05-18T01:11:38Z"},{"alias_kind":"arxiv_version","alias_value":"1607.00046v1","created_at":"2026-05-18T01:11:38Z"},{"alias_kind":"doi","alias_value":"10.48550/arxiv.1607.00046","created_at":"2026-05-18T01:11:38Z"},{"alias_kind":"pith_short_12","alias_value":"XKGDC76ANRAE","created_at":"2026-05-18T12:30:51Z"},{"alias_kind":"pith_short_16","alias_value":"XKGDC76ANRAESOAU","created_at":"2026-05-18T12:30:51Z"},{"alias_kind":"pith_short_8","alias_value":"XKGDC76A","created_at":"2026-05-18T12:30:51Z"}],"events":[{"event_type":"record_created","subject_pith_number":"pith:2016:XKGDC76ANRAESOAUSSTYRQAG6B","target":"record","payload":{"canonical_record":{"source":{"id":"1607.00046","kind":"arxiv","version":1},"metadata":{"license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2016-06-30T21:03:40Z","cross_cats_sorted":[],"title_canon_sha256":"1ef488aacd6009661c7c7368544ee84e3b8ee9197be43d877f123f79105eeb50","abstract_canon_sha256":"abe89c72df2d93c92bcaffecebfb3204715eca27d51789f131757fe4ad5dd32a"},"schema_version":"1.0"},"canonical_sha256":"ba8c317fc06c4049381494a788c006f05a054758440e422050cbb533219f7982","receipt":{"kind":"pith_receipt","key_id":"pith-v1-2026-05","algorithm":"ed25519","signed_at":"2026-05-18T01:11:38.133121Z","signature_b64":"xMffilQw09mp1IU7EAqniJoYsH7kAMUgLv9NFVQhsadxiaVb/pOPfH8TltXq0N8smK/CEQTVEenl2GII4BKJCw==","signed_message":"canonical_sha256_bytes","builder_version":"pith-number-builder-2026-05-17-v1","receipt_version":"0.3","canonical_sha256":"ba8c317fc06c4049381494a788c006f05a054758440e422050cbb533219f7982","last_reissued_at":"2026-05-18T01:11:38.132751Z","signature_status":"signed_v1","first_computed_at":"2026-05-18T01:11:38.132751Z","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54"},"source_kind":"arxiv","source_id":"1607.00046","source_version":1,"attestation_state":"computed"},"signer":{"signer_id":"pith.science","signer_type":"pith_registry","key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54"},"created_at":"2026-05-18T01:11:38Z","supersedes":[],"prev_event":null,"signature":{"signature_status":"signed_v1","algorithm":"ed25519","key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signature_b64":"cHQ9jabXsLEG4/SBl5UzaZFIpOGBkuuHuj2z3cTv3rfsu9CXLYNJo38ILjog1/f2451fHcd0cK/9YoF2rXNiBQ==","signed_message":"open_graph_event_sha256_bytes","signed_at":"2026-06-22T21:06:08.188749Z"},"content_sha256":"c1a696fa33704caad964c5c4c3d933cce9f46810629d88cfe981946878d8ec8f","schema_version":"1.0","event_id":"sha256:c1a696fa33704caad964c5c4c3d933cce9f46810629d88cfe981946878d8ec8f"},{"event_type":"graph_snapshot","subject_pith_number":"pith:2016:XKGDC76ANRAESOAUSSTYRQAG6B","target":"graph","payload":{"graph_snapshot":{"paper":{"title":"A Two-Stage Patient-Focused Study Design for Rare Disease Controlled Trials","license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","headline":"","cross_cats":[],"primary_cat":"stat.AP","authors_text":"Jian Yong, Sohaib H. Mohammad, Yan Yuan","submitted_at":"2016-06-30T21:03:40Z","abstract_excerpt":"We developed a study design for rare disease clinical trials (RDTs) that efficiently evaluate treatments, promotes access to new treatments during treatment development, and optimizes healthcare resource utilization for future treatment allocation, development, and prioritization. Comprehensive literature review and focus group discussion were conducted. To address the multifaceted challenges facing RDTs, four key issues for RDTs must be addressed, which are 1) the opportunity to access the new treatment; 2) assessment of outcomes where clinically validated outcomes may be lacking; 3) patient "},"claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"1607.00046","kind":"arxiv","version":1},"verdict":{"id":null,"model_set":{},"created_at":null,"strongest_claim":"","one_line_summary":"","pipeline_version":null,"weakest_assumption":"","pith_extraction_headline":""},"references":{"count":0,"sample":[],"resolved_work":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57","internal_anchors":0},"formal_canon":{"evidence_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"author_claims":{"count":0,"strong_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"builder_version":"pith-number-builder-2026-05-17-v1"},"verdict_id":null},"signer":{"signer_id":"pith.science","signer_type":"pith_registry","key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54"},"created_at":"2026-05-18T01:11:38Z","supersedes":[],"prev_event":null,"signature":{"signature_status":"signed_v1","algorithm":"ed25519","key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signature_b64":"2nZci6i/Kc9/gb9kPKAS3D5vfZHJutvL09svdwAbl/HYV6FQiHd3gZgXQRYlsXKCDXkQI8A/dpBJvuOvKW8HDw==","signed_message":"open_graph_event_sha256_bytes","signed_at":"2026-06-22T21:06:08.189088Z"},"content_sha256":"2795c49901d5a38377c858af4faf79eb5e0d0b5fd3839dfcb2a540089e68744c","schema_version":"1.0","event_id":"sha256:2795c49901d5a38377c858af4faf79eb5e0d0b5fd3839dfcb2a540089e68744c"}],"timestamp_proofs":[],"mirror_hints":[{"mirror_type":"https","name":"Pith Resolver","base_url":"https://pith.science","bundle_url":"https://pith.science/pith/XKGDC76ANRAESOAUSSTYRQAG6B/bundle.json","state_url":"https://pith.science/pith/XKGDC76ANRAESOAUSSTYRQAG6B/state.json","well_known_bundle_url":"https://pith.science/.well-known/pith/XKGDC76ANRAESOAUSSTYRQAG6B/bundle.json","status":"primary"}],"public_keys":[{"key_id":"pith-v1-2026-05","algorithm":"ed25519","format":"raw","public_key_b64":"stVStoiQhXFxp4s2pdzPNoqVNBMojDU/fJ2db5S3CbM=","public_key_hex":"b2d552b68890857171a78b36a5dccf368a953413288c353f7c9d9d6f94b709b3","fingerprint_sha256_b32_first128bits":"RVFV5Z2OI2J3ZUO7ERDEBCYNKS","fingerprint_sha256_hex":"8d4b5ee74e4693bcd1df2446408b0d54","rotates_at":null,"url":"https://pith.science/pith-signing-key.json","notes":"Pith uses this Ed25519 key to sign canonical record SHA-256 digests. Verify with: ed25519_verify(public_key, message=canonical_sha256_bytes, signature=base64decode(signature_b64))."}],"merge_version":"pith-open-graph-merge-v1","built_at":"2026-06-22T21:06:08Z","links":{"resolver":"https://pith.science/pith/XKGDC76ANRAESOAUSSTYRQAG6B","bundle":"https://pith.science/pith/XKGDC76ANRAESOAUSSTYRQAG6B/bundle.json","state":"https://pith.science/pith/XKGDC76ANRAESOAUSSTYRQAG6B/state.json","well_known_bundle":"https://pith.science/.well-known/pith/XKGDC76ANRAESOAUSSTYRQAG6B/bundle.json"},"state":{"state_type":"pith_open_graph_state","state_version":"1.0","pith_number":"pith:2016:XKGDC76ANRAESOAUSSTYRQAG6B","merge_version":"pith-open-graph-merge-v1","event_count":2,"valid_event_count":2,"invalid_event_count":0,"equivocation_count":0,"current":{"canonical_record":{"metadata":{"abstract_canon_sha256":"abe89c72df2d93c92bcaffecebfb3204715eca27d51789f131757fe4ad5dd32a","cross_cats_sorted":[],"license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2016-06-30T21:03:40Z","title_canon_sha256":"1ef488aacd6009661c7c7368544ee84e3b8ee9197be43d877f123f79105eeb50"},"schema_version":"1.0","source":{"id":"1607.00046","kind":"arxiv","version":1}},"source_aliases":[{"alias_kind":"arxiv","alias_value":"1607.00046","created_at":"2026-05-18T01:11:38Z"},{"alias_kind":"arxiv_version","alias_value":"1607.00046v1","created_at":"2026-05-18T01:11:38Z"},{"alias_kind":"doi","alias_value":"10.48550/arxiv.1607.00046","created_at":"2026-05-18T01:11:38Z"},{"alias_kind":"pith_short_12","alias_value":"XKGDC76ANRAE","created_at":"2026-05-18T12:30:51Z"},{"alias_kind":"pith_short_16","alias_value":"XKGDC76ANRAESOAU","created_at":"2026-05-18T12:30:51Z"},{"alias_kind":"pith_short_8","alias_value":"XKGDC76A","created_at":"2026-05-18T12:30:51Z"}],"graph_snapshots":[{"event_id":"sha256:2795c49901d5a38377c858af4faf79eb5e0d0b5fd3839dfcb2a540089e68744c","target":"graph","created_at":"2026-05-18T01:11:38Z","signer":{"key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signer_id":"pith.science","signer_type":"pith_registry"},"payload":{"graph_snapshot":{"author_claims":{"count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57","strong_count":0},"builder_version":"pith-number-builder-2026-05-17-v1","claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"formal_canon":{"evidence_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"paper":{"abstract_excerpt":"We developed a study design for rare disease clinical trials (RDTs) that efficiently evaluate treatments, promotes access to new treatments during treatment development, and optimizes healthcare resource utilization for future treatment allocation, development, and prioritization. Comprehensive literature review and focus group discussion were conducted. To address the multifaceted challenges facing RDTs, four key issues for RDTs must be addressed, which are 1) the opportunity to access the new treatment; 2) assessment of outcomes where clinically validated outcomes may be lacking; 3) patient ","authors_text":"Jian Yong, Sohaib H. Mohammad, Yan Yuan","cross_cats":[],"headline":"","license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2016-06-30T21:03:40Z","title":"A Two-Stage Patient-Focused Study Design for Rare Disease Controlled Trials"},"references":{"count":0,"internal_anchors":0,"resolved_work":0,"sample":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"1607.00046","kind":"arxiv","version":1},"verdict":{"created_at":null,"id":null,"model_set":{},"one_line_summary":"","pipeline_version":null,"pith_extraction_headline":"","strongest_claim":"","weakest_assumption":""}},"verdict_id":null}}],"author_attestations":[],"timestamp_anchors":[],"storage_attestations":[],"citation_signatures":[],"replication_records":[],"corrections":[],"mirror_hints":[],"record_created":{"event_id":"sha256:c1a696fa33704caad964c5c4c3d933cce9f46810629d88cfe981946878d8ec8f","target":"record","created_at":"2026-05-18T01:11:38Z","signer":{"key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signer_id":"pith.science","signer_type":"pith_registry"},"payload":{"attestation_state":"computed","canonical_record":{"metadata":{"abstract_canon_sha256":"abe89c72df2d93c92bcaffecebfb3204715eca27d51789f131757fe4ad5dd32a","cross_cats_sorted":[],"license":"http://arxiv.org/licenses/nonexclusive-distrib/1.0/","primary_cat":"stat.AP","submitted_at":"2016-06-30T21:03:40Z","title_canon_sha256":"1ef488aacd6009661c7c7368544ee84e3b8ee9197be43d877f123f79105eeb50"},"schema_version":"1.0","source":{"id":"1607.00046","kind":"arxiv","version":1}},"canonical_sha256":"ba8c317fc06c4049381494a788c006f05a054758440e422050cbb533219f7982","receipt":{"algorithm":"ed25519","builder_version":"pith-number-builder-2026-05-17-v1","canonical_sha256":"ba8c317fc06c4049381494a788c006f05a054758440e422050cbb533219f7982","first_computed_at":"2026-05-18T01:11:38.132751Z","key_id":"pith-v1-2026-05","kind":"pith_receipt","last_reissued_at":"2026-05-18T01:11:38.132751Z","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","receipt_version":"0.3","signature_b64":"xMffilQw09mp1IU7EAqniJoYsH7kAMUgLv9NFVQhsadxiaVb/pOPfH8TltXq0N8smK/CEQTVEenl2GII4BKJCw==","signature_status":"signed_v1","signed_at":"2026-05-18T01:11:38.133121Z","signed_message":"canonical_sha256_bytes"},"source_id":"1607.00046","source_kind":"arxiv","source_version":1}}},"equivocations":[],"invalid_events":[],"applied_event_ids":["sha256:c1a696fa33704caad964c5c4c3d933cce9f46810629d88cfe981946878d8ec8f","sha256:2795c49901d5a38377c858af4faf79eb5e0d0b5fd3839dfcb2a540089e68744c"],"state_sha256":"1157240bcdd13c4d8bdf8a5e63691e4528b6e6ede4f18a740688d08af780f8b6"},"bundle_signature":{"signature_status":"signed_v1","algorithm":"ed25519","key_id":"pith-v1-2026-05","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54","signature_b64":"gtxkfUwClxW8guGs5446eEJ4KBv6SY09/udqs+843Ws02cORrPFMNxj/iaZ5bbfVMbYsj5itpoFY77pwhG+5Dg==","signed_message":"bundle_sha256_bytes","signed_at":"2026-06-22T21:06:08.190988Z","bundle_sha256":"4916d268cbd564c76b2bb2c0530266f419a5c97ef4984c25a5aa7de183b02399"}}