{"id":"W2795592729","doi":"10.1371/journal.pbio.2004879","title":"Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?","year":2018,"lang":"en","type":"article","venue":"PLoS Biology","topic":"Ethics in Clinical Research","field":"Medicine","cited_by":73,"is_retracted":false,"has_abstract":true,"ca_institutions":"McGill University","funders":"Deutsche Forschungsgemeinschaft","keywords":"Clinical trial; Sample size determination; Research design; Clinical study design; MEDLINE; Family medicine; Medical physics; Medicine; Biology; 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":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.00475099,0.0002045325,0.0007336938,0.00017457,0.0001322282,0.00001632394,0.00041698,0.0007885389,0.0003010388],"category_scores_gemma":[0.136871,0.0001454235,0.0001175352,0.0002545988,0.002304888,0.0000441918,0.000508335,0.002717273,0.0003940356],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001423701,"about_ca_system_score_gemma":0.0007375677,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001282712,"about_ca_topic_score_gemma":0.0008628087,"domain_scores_codex":[0.9967618,0.00059574,0.0008287762,0.0007805442,0.0004093588,0.0006237666],"domain_scores_gemma":[0.9683091,0.02928613,0.0002100376,0.0009642442,0.0007758412,0.0004546339],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.0006307021,0.001383182,0.9501346,0.0002854233,0.0006144085,0.00003910363,0.001184633,0.000001438868,0.008290003,0.03292789,0.001960644,0.002548006],"study_design_scores_gemma":[0.006709762,0.007744274,0.1852068,0.001376403,0.0002186409,0.00001664981,0.0007856719,0.0001850612,0.006348352,0.7839072,0.00705869,0.0004424807],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9787623,0.001104287,0.000008944713,0.005764191,0.0004281208,0.0006026963,0.00001698714,0.00008585893,0.01322661],"genre_scores_gemma":[0.9869632,0.004460975,0.004156181,0.002159746,0.001044455,0.00008101652,0.0000131034,0.00003087142,0.001090516],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.7649277,"threshold_uncertainty_score":0.9995835,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.6524508332768663,"score_gpt":0.6397451593480271,"score_spread":0.01270567392883915,"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."}}