{"id":"W3047282220","doi":"10.1080/19466315.2020.1804444","title":"Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19","year":2020,"lang":"en","type":"article","venue":"Statistics in Biopharmaceutical Research","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":9,"is_retracted":false,"has_abstract":true,"ca_institutions":"Eli Lilly (Canada)","funders":"","keywords":"Coronavirus disease 2019 (COVID-19); Clinical trial; Medicine; Pandemic; 2019-20 coronavirus outbreak; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Medical emergency; Medical physics; 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":[{"model":"gemma","categories":["metaresearch"],"domain":"methods","study_design":"theoretical_or_conceptual","genre":"methods","about_ca_system":false,"about_ca_topic":false,"confidence":"low","status":"direct model label, unvalidated"},{"model":"gpt","categories":[],"domain":null,"study_design":"observational","genre":"methods","about_ca_system":false,"about_ca_topic":false,"confidence":"medium","status":"direct model label, unvalidated"}],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow","research_integrity"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.03570816,0.0003616977,0.001479497,0.0001574083,0.0004394486,0.0001236666,0.0005779733,0.0003291033,0.0005618733],"category_scores_gemma":[0.711593,0.0002949483,0.0001539366,0.000767911,0.002196649,0.00006254579,0.0007321509,0.002386804,0.00002139174],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004135509,"about_ca_system_score_gemma":0.001035188,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0000152199,"about_ca_topic_score_gemma":0.000009619626,"domain_scores_codex":[0.9851602,0.008045508,0.002784151,0.001207041,0.001561728,0.001241368],"domain_scores_gemma":[0.5561916,0.4397702,0.0002462373,0.0004357113,0.0006880656,0.002668182],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.05578055,0.001144275,0.000857811,0.002105024,0.0003776248,0.0001341578,0.0005352102,0.000001281623,0.0004292039,0.4798917,0.4191973,0.03954586],"study_design_scores_gemma":[0.05208514,0.001611252,0.0001711444,0.00007804989,0.0001374959,0.000001675949,0.0006006702,0.00618141,0.0001117418,0.9019262,0.03672257,0.0003726262],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":"theoretical_or_conceptual","genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.007017368,0.00111065,0.9299979,0.04271328,0.001235734,0.008122859,0.009129282,0.0001820911,0.000490886],"genre_scores_gemma":[0.02054553,0.003587388,0.971283,0.003057616,0.0007432725,0.0004242364,0.0000388585,0.00008384158,0.0002362668],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.6758849,"threshold_uncertainty_score":0.9999503,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.9333092801230759,"score_gpt":0.7976081043465881,"score_spread":0.1357011757764878,"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."}}