{"id":"W3154880036","doi":"10.1016/j.esmoop.2021.100117","title":"Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring","year":2021,"lang":"en","type":"review","venue":"ESMO Open","topic":"Economic and Financial Impacts of Cancer","field":"Economics, Econometrics and Finance","cited_by":71,"is_retracted":false,"has_abstract":true,"ca_institutions":"Queen's University","funders":"Cilag; Foundation Medicine; Chugai Pharmaceutical; Novartis Farmacéutica; European Society for Medical Oncology; Shire; Eisai; Seagen; G1 Therapeutics; Genentech; Veracyte; SkylineDx; Roche; Nordic Nanovector; Meso Scale Diagnostics; Les Laboratories Pierre Fabre; Celldex Therapeutics; Ipsen; Array BioPharma; Merck KGaA; Taiho Pharmaceutical; F. Hoffmann-La Roche; Amgen; Boehringer Ingelheim; Radius Health; Daiichi Sankyo Europe; Servier; Bayer; Gilead Sciences; NeraCare; Cancer Research UK; World Health Organization; Sanofi; Novartis; Ariad Pharmaceuticals; Pfizer; AstraZeneca; Eli Lilly and Company; Samsung; Bristol-Myers Squibb","keywords":"Medicine; Clinical trial; Scale (ratio); Food and drug administration; Agency (philosophy); Clinical study design; Medical physics; Research design; Risk analysis (engineering); Pathology; Statistics","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":["metaresearch"],"category_scores_codex":[0.7340543,0.002029772,0.005399523,0.01037833,0.002595751,0.01005755,0.006657967,0.006422538,0.003722826],"category_scores_gemma":[0.8747337,0.002651527,0.009657488,0.01120838,0.01153542,0.007925401,0.008823732,0.006776901,0.000889871],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0119759,"about_ca_system_score_gemma":0.03087669,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003448222,"about_ca_topic_score_gemma":0.004950287,"domain_scores_codex":[0.132418,0.6105291,0.1750837,0.01400476,0.06639928,0.001565307],"domain_scores_gemma":[0.04689937,0.8232219,0.06022838,0.03283797,0.03612541,0.0006869534],"domain_codex":"methods","domain_gemma":"methods","domain_candidate":"methods","domain_consensus":"methods","study_design_codex":"design_other","study_design_gemma":"systematic_review","study_design_scores_codex":[0.003029084,0.0002787727,0.03758686,0.1893035,0.01876081,0.0005515527,0.01517052,0.00614323,0.001441478,0.1411193,0.03410025,0.5525147],"study_design_scores_gemma":[0.003768574,0.001825708,0.0383086,0.2966826,0.02564637,0.001768842,0.003806713,0.01350449,0.008708901,0.3042921,0.3005021,0.001185043],"study_design_candidate":"systematic_review","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"review","genre_scores_codex":[0.03622961,0.3172191,0.4500585,0.104825,0.01797945,0.04071749,0.006308658,0.001115735,0.02554631],"genre_scores_gemma":[0.3548137,0.06048915,0.4626198,0.0424903,0.004558103,0.0700845,0.002111652,0.0006277465,0.002205134],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.2659457,"threshold_uncertainty_score":0.3279585,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.5438960934358554,"score_gpt":0.5372332370321362,"score_spread":0.00666285640371922,"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."}}