{"entity":{"id":"idea-tr1-home-infusion-trial-drugs","kind":"idea","name":"Home infusion and local blood draws for trial drugs after the first cycles","aka":[],"tldr":"Once a patient has safely had the first few doses of a trial drug at the hospital, later doses could be given at home or a local clinic, with blood tests done nearby, so distance no longer decides who can join.","summary":"Protocols pre-specify a decentralised phase: after two or three supervised cycles, eligible patients receive subcutaneous or infused trial drug via home-infusion nursing or a local clinic under the site investigator's oversight, with labs at community draw stations, ePRO-based toxicity capture and telehealth visits. Pandemic-era regulatory flexibilities showed feasibility; the idea is to write it into protocols by default for drugs with predictable safety.","asOf":"2026-09-08","links":[{"label":"FDA Oncology Center of Excellence: Project Community (archived copy)","url":"https://web.archive.org/web/20250115091955/https://www.fda.gov/about-fda/oncology-center-excellence/project-community"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["pembrolizumab","nivolumab","trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-enrolment","b-trial-diversity"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Trials with a decentralised phase will enrol a higher share of patients living more than 60 minutes from the site and have lower dropout, with no increase in protocol deviations affecting the primary endpoint.","rationale":"Travel burden is one of the most cited reasons for declining trials. Home administration of biologics is routine in rheumatology and haemophilia, and subcutaneous formulations of checkpoint inhibitors and anti-HER2 antibodies exist.","test":"Randomise consenting patients at cycle 3 to continued site visits versus home/local administration in a phase 3 trial of an established biologic class, comparing retention, deviations and patient-reported burden.","maturity":"early-clinical","actor":"industry","cost":"medium","horizonYears":3},"route":"/ideas/idea-tr1-home-infusion-trial-drugs/","neighbours":{"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"bottleneck":[{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}