{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.6283856,0.003472354,0.004695933,0.0152033,0.004803491,0.02229961,0.00583866,0.01022289,0.03037787],"category_scores_gemma":[0.79224,0.003497127,0.01358301,0.01369595,0.003970146,0.0129345,0.009890893,0.01486047,0.01665099],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.009498791,"about_ca_system_score_gemma":0.03292686,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002862263,"about_ca_topic_score_gemma":0.005108936,"domain_scores_codex":[0.1986116,0.5251114,0.1869252,0.008843302,0.07666125,0.003847313],"domain_scores_gemma":[0.1067476,0.5165206,0.1421681,0.08290655,0.1467028,0.004954265],"domain_codex":"methods","domain_gemma":"methods","domain_candidate":"methods","domain_consensus":"methods","study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.01148736,0.0003901691,0.01205865,0.03501975,0.006472181,0.0005088219,0.004367852,0.004119429,0.003152919,0.03350153,0.4372143,0.4517072],"study_design_scores_gemma":[0.002507076,0.001677494,0.01420942,0.02455198,0.002442547,0.0006612914,0.0008686972,0.004560729,0.004893732,0.03305233,0.9099886,0.0005859678],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.01692638,0.03629385,0.4453793,0.1008234,0.03370092,0.165247,0.0828526,0.01907764,0.09969901],"genre_scores_gemma":[0.0808738,0.0113049,0.6664299,0.05096586,0.01068483,0.1318655,0.02442433,0.006091557,0.01735935],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.3716144,"threshold_uncertainty_score":0.4582667,"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."}}