{"id":"W2898387476","doi":"10.1093/annonc/mdy297.007","title":"Magnitude of clinical benefit in trials supporting US Food and Drug Administration (FDA) accelerated approval (AA) and European Medicines Agency (EMA) conditional marketing authorisation (CMA) and subsequent trials supporting conversion to full approval","year":2018,"lang":"en","type":"article","venue":"Annals of Oncology","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"Princess Margaret Cancer Centre","funders":"","keywords":"Medicine; Clinical trial; Food and drug administration; Marketing authorization; Authorization; Family medicine; Internal medicine; Pharmacology; Bioinformatics","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":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.1882299,0.0007163986,0.002104732,0.005856215,0.0009314619,0.003656807,0.00093943,0.001394868,0.004386429],"category_scores_gemma":[0.24601,0.000378815,0.004991788,0.004412519,0.002304153,0.003992761,0.003038085,0.002282175,0.0004685893],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002185458,"about_ca_system_score_gemma":0.003534658,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004042935,"about_ca_topic_score_gemma":0.001244667,"domain_scores_codex":[0.8457144,0.07627943,0.04621535,0.008115598,0.02182824,0.001846969],"domain_scores_gemma":[0.4302995,0.3600763,0.1636366,0.01147336,0.02880204,0.005712214],"domain_codex":null,"domain_gemma":"evaluation","domain_candidate":"evaluation","domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.06359781,0.000566509,0.6255468,0.04653223,0.03024462,0.0003214309,0.002245603,0.002690693,0.004142975,0.005741728,0.01482022,0.2035493],"study_design_scores_gemma":[0.01032239,0.01876952,0.8405195,0.01524917,0.027667,0.001685916,0.001308014,0.00301063,0.004820004,0.007934522,0.06830364,0.0004097878],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.6824598,0.2190848,0.01185294,0.01326425,0.001855276,0.01458942,0.01585292,0.0003019311,0.0407386],"genre_scores_gemma":[0.9752086,0.006670152,0.007328188,0.001892126,0.000646574,0.004390567,0.003272353,0.00004371508,0.0005476769],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.8117701,"threshold_uncertainty_score":0.9954668,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.4063064808284143,"score_gpt":0.4844896776090462,"score_spread":0.0781831967806319,"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."}}