{"id":"W4323046146","doi":"10.3389/fonc.2023.1144056","title":"Project Optimus, an FDA initiative: Considerations for cancer drug development internationally, from an academic perspective","year":2023,"lang":"en","type":"article","venue":"Frontiers in Oncology","topic":"Cancer Genomics and Diagnostics","field":"Biochemistry, Genetics and Molecular Biology","cited_by":53,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Tolerability; Drug development; Medicine; Clinical trial; Excellence; Cancer drugs; Drug; Pharmacology; Political science; Internal medicine; Adverse effect","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":[],"consensus_categories":[],"category_scores_codex":[0.0002139142,0.0001294617,0.0001868134,0.0001486101,0.00009640829,0.00001876077,0.0001686016,0.0001918774,0.00001942296],"category_scores_gemma":[0.0003028817,0.0001448482,0.00003525898,0.00009863389,0.0000817117,0.00001196985,0.00008860663,0.000143235,0.000002563736],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004204408,"about_ca_system_score_gemma":0.001573018,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0005268333,"about_ca_topic_score_gemma":0.007980137,"domain_scores_codex":[0.9989434,0.00008111632,0.0002450773,0.0004259379,0.00007176913,0.0002327229],"domain_scores_gemma":[0.9994133,0.0001087791,0.00009383445,0.0001460427,0.0001738459,0.00006416693],"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":[0.001485688,0.0008212061,0.112763,0.00003435098,0.000927904,0.00006657674,0.04135628,0.01116856,0.03407796,0.00657906,0.7422349,0.04848454],"study_design_scores_gemma":[0.006353041,0.001470945,0.04343751,0.00005540199,0.00009780398,0.00001009408,0.02912075,0.01397579,0.03877411,0.0420844,0.8234235,0.001196653],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9839731,0.001251292,0.007814603,0.002591653,0.002108698,0.0008330971,0.0006955998,0.00003333712,0.0006985473],"genre_scores_gemma":[0.8927502,0.002835238,0.09464189,0.00368154,0.001321846,0.001690876,0.0025044,0.00006437534,0.0005096601],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.09122299,"threshold_uncertainty_score":0.5906737,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04628795613636401,"score_gpt":0.385014430783936,"score_spread":0.338726474647572,"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."}}