{"id":"W2134095592","doi":"10.1158/1078-0432.ccr-06-0909","title":"Setting the Bar in Phase II Trials: The Use of Historical Data for Determining “Go/No Go” Decision for Definitive Phase III Testing","year":2007,"lang":"en","type":"review","venue":"Clinical Cancer Research","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":67,"is_retracted":false,"has_abstract":true,"ca_institutions":"Immunovaccine (Canada)","funders":"National Cancer Institute; National Institutes of Health","keywords":"Null hypothesis; Clinical trial; Medicine; Null (SQL); Sample size determination; Protocol (science); Phase (matter); Statistics; Oncology; Research design; Internal medicine; Data mining; Computer science; Pathology; Alternative medicine; Mathematics","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":["metaresearch","metaepi_narrow","research_integrity"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.2848443,0.000720015,0.008078989,0.0003736758,0.0008344031,0.0001862802,0.004170471,0.001280057,0.0001459333],"category_scores_gemma":[0.9634472,0.0003890823,0.001714823,0.001487334,0.001299442,0.0001816083,0.002692532,0.004402364,0.00001438744],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000996003,"about_ca_system_score_gemma":0.003029011,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00009226515,"about_ca_topic_score_gemma":0.00006235845,"domain_scores_codex":[0.9559845,0.02267308,0.01499446,0.002367519,0.002197579,0.001782866],"domain_scores_gemma":[0.06398237,0.9258263,0.003991176,0.003561369,0.002228803,0.0004100262],"domain_codex":null,"domain_gemma":"methods","domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.003353956,0.001260334,0.000002781685,0.004776169,0.0002780509,0.00001717556,0.00004720825,5.397701e-7,5.333167e-7,0.001265004,0.04917443,0.9398238],"study_design_scores_gemma":[0.01155686,0.003007997,4.574093e-7,0.0183481,0.001620355,0.000004850597,0.00003256501,0.002901763,0.000001676154,0.06354497,0.8985676,0.0004127875],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"methods","genre_scores_codex":[0.00006118372,0.7244115,0.2375186,0.000478864,0.004022721,0.02284996,0.01042111,0.0000722178,0.000163821],"genre_scores_gemma":[0.000003250025,0.4635728,0.5296381,0.0001224889,0.003580105,0.002603053,0.00006859809,0.0001787731,0.000232857],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.939411,"threshold_uncertainty_score":0.9998561,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.991818251432903,"score_gpt":0.8241548003108323,"score_spread":0.1676634511220707,"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."}}