{"id":"W4239469862","doi":"10.1089/blr.2011.9992","title":"A Close Look at Non-Inferiority Trials; FDA Issues Guidance on Safety for Clinical Trials; Geron Human Embryonic Stem Cell Trial Starts; National Academy of Sciences Discusses Postmarketing Trials; Bone Marrow Stem Cell Trial Authorized in Israel; Canadian Company Asked to Submit Proposal on Brain Injury Treatment to DoD","year":2011,"lang":"en","type":"article","venue":"Biotechnology Law Report","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"","keywords":"Clinical trial; Stem cell; Medicine; Embryonic stem cell; Internal medicine; Biology","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.1637257,0.002359066,0.005347051,0.005626575,0.01050728,0.02594364,0.008588112,0.1724849,0.01363193],"category_scores_gemma":[0.3382676,0.003492396,0.005684934,0.003197453,0.03709602,0.019998,0.006708154,0.1163325,0.008709499],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.009991236,"about_ca_system_score_gemma":0.02584781,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007515839,"about_ca_topic_score_gemma":0.02444393,"domain_scores_codex":[0.8208144,0.1156857,0.01605714,0.00864051,0.03427764,0.004524459],"domain_scores_gemma":[0.4085004,0.5370626,0.0104024,0.009132317,0.02671546,0.008186848],"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":[0.0001115579,0.0001200896,0.0002628303,0.0007127041,0.00008681023,0.0006580118,0.001047791,0.0001829365,0.0004280894,0.1354759,0.830005,0.03090838],"study_design_scores_gemma":[0.0004003534,0.0001548164,0.0007412516,0.00320859,0.0001460909,0.001024145,0.0005206404,0.0003986549,0.0003577693,0.1514299,0.8414231,0.0001946526],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.0002401026,0.01449717,0.005720434,0.9230056,0.01814133,0.0002457698,0.000110428,0.0001623567,0.03787675],"genre_scores_gemma":[0.003394141,0.003136857,0.006912202,0.9585859,0.0165586,0.0003149172,0.00003237166,0.000167982,0.01089696],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.1724849,"threshold_uncertainty_score":0.8658747,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.217967746319671,"score_gpt":0.4613964784922311,"score_spread":0.2434287321725601,"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."}}