{"id":"W2339853514","doi":"10.1056/nejmsb1601674","title":"Challenges to Data Monitoring Committees When Regulatory Authorities Intervene","year":2016,"lang":"en","type":"article","venue":"New England Journal of Medicine","topic":"Heart Failure Treatment and Management","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"Université de Montréal; Montreal Heart Institute","funders":"Sahlgrenska Akademin; Institut de Cardiologie de Montréal; Göteborgs Universitet; SUNY Downstate Medical Center; Université de Montréal; University of Michigan; Imperial College London; London School of Hygiene and Tropical Medicine","keywords":"Medicine; Aliskiren; Clinical trial; Harm; Drug approval; Enalapril; Intensive care medicine; Data monitoring committee; Medical emergency; Pharmacology; Internal medicine; Drug; Law; Renin–angiotensin system; Political science","routes":{"ca_aff":true,"ca_fund":true,"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":[0.478221,0.001500549,0.004054531,0.004868854,0.01687984,0.0317451,0.01559629,0.08017625,0.01018744],"category_scores_gemma":[0.6681731,0.003657686,0.005852576,0.005520106,0.02184278,0.03970207,0.01507724,0.1068487,0.009181978],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01082495,"about_ca_system_score_gemma":0.07362211,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.006656614,"about_ca_topic_score_gemma":0.00797521,"domain_scores_codex":[0.5177739,0.2615926,0.07687376,0.02276831,0.09935134,0.02164006],"domain_scores_gemma":[0.1203212,0.4983917,0.04393544,0.05663494,0.2182527,0.06246387],"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":[0.0001766263,0.0001980399,0.001756455,0.0006986926,0.0001403494,0.001390802,0.004290868,0.000329629,0.0005089777,0.02259502,0.9072372,0.06067729],"study_design_scores_gemma":[0.0002638733,0.0001437856,0.001612128,0.002701292,0.0001117568,0.001062163,0.005321219,0.001119446,0.0006406775,0.04017747,0.9465193,0.0003267897],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"commentary","genre_scores_codex":[0.0006931539,0.002183466,0.005388575,0.968076,0.02014165,0.0002043142,0.00005593295,0.0003141008,0.002942777],"genre_scores_gemma":[0.01376536,0.001920641,0.01844585,0.941079,0.02006761,0.0007475847,0.00018171,0.000322655,0.003469591],"genre_candidate":"commentary","genre_consensus":"commentary","teacher_disagreement_score":0.478221,"threshold_uncertainty_score":0.6434464,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1330799936756226,"score_gpt":0.3487657376055108,"score_spread":0.2156857439298882,"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."}}