{"id":"W4389775441","doi":"10.1212/wnl.0000000000207958","title":"FDA Patient-Focused Drug Development Guidances","year":2023,"lang":"en","type":"article","venue":"Neurology","topic":"Genomics and Rare Diseases","field":"Biochemistry, Genetics and Molecular Biology","cited_by":36,"is_retracted":false,"has_abstract":true,"ca_institutions":"Technical University of Nova Scotia","funders":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","keywords":"Drug development; Clinical trial; Medicine; Disease; Limiting; Intensive care medicine; Food and drug administration; Drug; Psychology; Psychiatry; Risk analysis (engineering); Pathology","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.007315856,0.001212428,0.001259487,0.001956361,0.001062691,0.002977565,0.003909405,0.009424864,0.05663935],"category_scores_gemma":[0.01687431,0.0007578925,0.002473102,0.001737852,0.0009153425,0.001903667,0.0015191,0.005572905,0.02970362],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00252787,"about_ca_system_score_gemma":0.008127326,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007975837,"about_ca_topic_score_gemma":0.01564584,"domain_scores_codex":[0.9930433,0.002142396,0.0005719636,0.0005300962,0.003105904,0.0006062723],"domain_scores_gemma":[0.9879465,0.003335114,0.001238141,0.0006772119,0.006006183,0.0007969582],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0001783319,0.0001815229,0.0002683466,0.001004842,0.00002770129,0.0003692583,0.00008253146,0.0004174654,0.001317643,0.01212368,0.7572236,0.2268051],"study_design_scores_gemma":[0.00008749361,0.0001045113,0.0003054832,0.0006351676,0.0000204295,0.0003411696,0.00001910042,0.0001115758,0.0003399763,0.001415663,0.9966058,0.00001364999],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.003744521,0.07419188,0.02261036,0.09479004,0.01153669,0.003966462,0.0158929,0.006851276,0.7664158],"genre_scores_gemma":[0.04856065,0.1353268,0.06112663,0.1951769,0.006103608,0.008520584,0.02970201,0.001443054,0.5140399],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.05663935,"threshold_uncertainty_score":0.1894775,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.008126388775556123,"score_gpt":0.214795056135779,"score_spread":0.2066686673602229,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}