{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch","research_integrity"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.8293232,0.002102733,0.005633715,0.01090959,0.003262392,0.01651044,0.006864802,0.008552329,0.01249511],"category_scores_gemma":[0.9339045,0.004213829,0.005151569,0.01328894,0.01747791,0.03479354,0.01194633,0.01024532,0.004738948],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.007790208,"about_ca_system_score_gemma":0.02197195,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001299773,"about_ca_topic_score_gemma":0.001926693,"domain_scores_codex":[0.1037362,0.7328324,0.09282485,0.01072348,0.05768537,0.002197706],"domain_scores_gemma":[0.01979743,0.7322238,0.1170253,0.09117357,0.03806636,0.001713424],"domain_codex":"methods","domain_gemma":"evaluation","domain_candidate":"evaluation","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.01098123,0.001287396,0.06702112,0.05216031,0.006138596,0.0006201743,0.03925233,0.002401679,0.004454821,0.1030749,0.07447464,0.6381329],"study_design_scores_gemma":[0.008766839,0.0101964,0.1392615,0.1197687,0.005142837,0.002032026,0.009509887,0.01025429,0.01272984,0.2271391,0.45374,0.001458564],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.1033551,0.05993837,0.5014871,0.1629396,0.01719523,0.07940507,0.01167641,0.002115133,0.06188796],"genre_scores_gemma":[0.3819875,0.008472885,0.4770762,0.04800794,0.005302163,0.07291882,0.002252152,0.0008633313,0.003118984],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.9914477,"threshold_uncertainty_score":0.2104749,"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."}}