{"id":"W4401691029","doi":"10.18609/cgti.2024.052","title":"Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)","year":2024,"lang":"en","type":"article","venue":"Cell and Gene Therapy Insights","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"European union; Clinical trial; Medicine; Genetically modified organism; Business; Biotechnology; Biology; International trade; Internal medicine; Genetics","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":[0.1264551,0.0001950758,0.0004583004,0.001005672,0.001432862,0.006729332,0.0008052199,0.002725684,0.006523473],"category_scores_gemma":[0.1240306,0.0003210868,0.0005705661,0.002260932,0.002431249,0.00439977,0.003362457,0.003178053,0.001736499],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002856166,"about_ca_system_score_gemma":0.006866817,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001874897,"about_ca_topic_score_gemma":0.002615563,"domain_scores_codex":[0.9029406,0.06182218,0.006988098,0.003533585,0.02100116,0.003714307],"domain_scores_gemma":[0.8168108,0.1280442,0.01889413,0.004160275,0.02649357,0.005596968],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.001996423,0.0005653856,0.06789958,0.005584037,0.0002132009,0.001851262,0.04061405,0.000857699,0.008697351,0.03850994,0.1689623,0.6642488],"study_design_scores_gemma":[0.00004980977,0.0007982876,0.03883337,0.002125042,0.0000633237,0.002247585,0.01542072,0.0002914402,0.002748756,0.002627902,0.9346963,0.00009759649],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.4460554,0.09398245,0.0223791,0.1589247,0.001942699,0.001478787,0.0037846,0.0005710967,0.2708812],"genre_scores_gemma":[0.81576,0.04310222,0.01464261,0.07977446,0.0008398932,0.0007199172,0.002299466,0.0004012652,0.04246021],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1264551,"threshold_uncertainty_score":0.6687667,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1905114425597662,"score_gpt":0.3988132931859616,"score_spread":0.2083018506261954,"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."}}