{"entity":{"id":"idea-tr2-combo-readiness-dossier","kind":"idea","name":"Every approved cancer drug ships with a public combination-readiness data pack","aka":[],"tldr":"Require that approved cancer drugs come with a standard set of data (blood levels, drug interactions, toxicity profile) so anyone can design a safe combination trial without asking the company.","summary":"Combination trial designers need pharmacokinetic profiles, metabolic pathways, QT effects, myelosuppression kinetics and immunogenicity data that sit in confidential regulatory dossiers. A standardised, machine-readable 'combination-readiness' annex published at approval would let academics and other companies design combination studies and predict overlapping toxicity without bilateral negotiation.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Too many combinations to test): Palmer & Sorger, Combination cancer therapy can confer benefit via patient-to-patient variability without drug additivity or synergy (Cell 2017)","url":"https://doi.org/10.1016/j.cell.2017.11.009"}],"tags":[],"related":["fda-approvals","drugbank-chembl","idea-tr2-combination-template-agreement"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-combination-space","b-ip-collaboration"],"keyPapers":["paper-palmer-cell"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Publication of readiness packs increases the number of investigator-initiated combination trials involving newly approved drugs by at least 30% within three years.","rationale":"Open pharmacology data (as in the FDA labels' clinical pharmacology sections, but structured and complete) removes an information asymmetry that currently forces every combination through the originator.","test":"Pilot voluntary packs for ten recently approved oncology drugs and count investigator-initiated combination trials registered within two years compared with matched drugs without packs.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-tr2-combo-readiness-dossier/","neighbours":{"collection":[{"id":"drugbank-chembl","kind":"collection","name":"DrugBank & ChEMBL","route":"/collections/drugbank-chembl/"},{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","route":"/collections/fda-approvals/"}],"idea":[{"id":"idea-tr2-combination-template-agreement","kind":"idea","name":"A standard cross-company combination agreement that takes weeks, not years, to sign","route":"/ideas/idea-tr2-combination-template-agreement/"}],"bottleneck":[{"id":"b-ip-collaboration","kind":"bottleneck","name":"Secrecy and intellectual property block collaboration","route":"/bottlenecks/b-ip-collaboration/"},{"id":"b-combination-space","kind":"bottleneck","name":"Too many combinations to test","route":"/bottlenecks/b-combination-space/"}],"paper":[{"id":"paper-palmer-cell","kind":"paper","name":"Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy","route":"/key-papers/paper-palmer-cell/"}]}}