# Home infusion and local blood draws for trial drugs after the first cycles

Source: https://onco.cc/ideas/idea-tr1-home-infusion-trial-drugs/  
OnCo record `idea-tr1-home-infusion-trial-drugs` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- FDA Oncology Center of Excellence: Project Community (archived copy): https://web.archive.org/web/20250115091955/https://www.fda.gov/about-fda/oncology-center-excellence/project-community

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- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- bottlenecks: [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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