{"id":"W3008432399","doi":"10.1038/s41571-020-0345-7","title":"Real-world evidence and regulatory drug approval","year":2020,"lang":"en","type":"review","venue":"Nature Reviews Clinical Oncology","topic":"Economic and Financial Impacts of Cancer","field":"Economics, Econometrics and Finance","cited_by":49,"is_retracted":false,"has_abstract":false,"ca_institutions":"Queen's University","funders":"","keywords":"Real world evidence; Drug approval; Drug; Cancer drugs; Regulatory science; Drug development; Medicine; Business; Pharmacology; Internal medicine","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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","research_integrity","insufficient_payload"],"consensus_categories":["research_integrity"],"category_scores_codex":[0.006858515,0.0007980156,0.01170008,0.0003132874,0.0001099939,0.00007710007,0.0009807914,0.002575899,0.0003292266],"category_scores_gemma":[0.006408094,0.0007115338,0.001990922,0.0005870351,0.0004693458,0.0003509715,0.0004307195,0.004668232,0.002554249],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0007718096,"about_ca_system_score_gemma":0.0009142945,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00007543943,"about_ca_topic_score_gemma":0.0001777375,"domain_scores_codex":[0.9908795,0.0005621251,0.006047226,0.001839276,0.00006052173,0.0006113769],"domain_scores_gemma":[0.9905201,0.002524546,0.005245083,0.001045679,0.00005623467,0.0006083969],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00001532542,0.00006971315,0.0002317983,0.005666786,0.0001333831,0.00002446264,0.00001716566,2.017453e-8,2.091577e-9,0.05690808,0.05054822,0.886385],"study_design_scores_gemma":[0.0003045128,0.0002176287,0.0003664166,0.006126552,0.0003593016,0.00002032387,0.000001409891,0.000004364762,9.91828e-9,0.003355365,0.9885516,0.0006925252],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.000004162741,0.9578884,0.00001488862,0.001508423,0.003145553,0.001851071,0.0001207676,0.00006184667,0.03540486],"genre_scores_gemma":[0.00001000874,0.988048,0.001636281,0.002707806,0.003342105,0.0002102267,0.0000352545,0.0001091667,0.003901181],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9380034,"threshold_uncertainty_score":0.9995336,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2449672496099359,"score_gpt":0.4663884499916672,"score_spread":0.2214212003817313,"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."}}