{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.08068304,0.0006512462,0.004412223,0.001132152,0.000553639,0.00004752467,0.0004565203,0.002664047,0.00005799998],"category_scores_gemma":[0.008342667,0.0004463349,0.001008749,0.0008400177,0.001372621,0.00009361912,0.0001658464,0.0009808476,0.00001473367],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00155913,"about_ca_system_score_gemma":0.003057842,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.005572882,"about_ca_topic_score_gemma":0.007548964,"domain_scores_codex":[0.9850059,0.004049838,0.006957693,0.0016985,0.001353223,0.0009348949],"domain_scores_gemma":[0.9904923,0.004726549,0.003175028,0.0005853667,0.0003095081,0.0007112579],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.8257329,0.005134602,0.00106267,0.0003877586,0.0005323692,0.000242012,0.0006535259,0.000006107569,0.09587318,0.04306218,0.004675634,0.02263705],"study_design_scores_gemma":[0.4454995,0.07859003,0.005101952,0.001336723,0.001034475,0.0000815811,0.0005907142,0.0001811505,0.3518455,0.003899619,0.1102236,0.001615146],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9195217,0.0001625333,0.00005355701,0.06088445,0.001561868,0.01614877,0.0004351104,0.00013912,0.001092913],"genre_scores_gemma":[0.9926332,0.00009078303,0.002521525,0.0008809087,0.001251856,0.0006868372,0.000115915,0.00006215347,0.001756843],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3802333,"threshold_uncertainty_score":0.9997988,"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."}}