OnCo
ideasIdea

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

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.

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.

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.
What would test it
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
Who has to act
industry
Cost to try
Medium ($1M to $50M)
Years to first evidence
3
Bottlenecks it attacks

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