OnCo
ideasIdea

Drop mandatory fresh biopsies where blood or archival tissue would do

Many trials require a new tumour biopsy just to enter, even when the sample is only for research. Allowing blood tests or stored tissue instead would remove a painful and risky hurdle that puts many patients off.

Protocols classify each biopsy as essential (eligibility-defining, no alternative) or research-only; research-only biopsies become optional sub-studies, and eligibility biomarkers may be assessed on archival tissue or ctDNA where analytically validated. Screen-failure and refusal attributable to biopsy requirements are tracked and published.

Hypothesis
Removing mandatory research biopsies will reduce screen failure and refusal rates by a measurable margin and shorten time to enrolment, without loss of the biomarker data needed for the primary analysis.
Rationale
Mandatory biopsies are among the most frequently cited reasons patients decline early-phase trials, and a notable share of biopsies yield insufficient tissue. Liquid biopsy now matches tissue for many actionable alterations.
What would test it
A sponsor amends a set of ongoing trials to make research biopsies optional and compares screen failure, refusal and enrolment speed before and after amendment.
Maturity
early clinical
Who has to act
industry
Cost to try
Small (under $1M)
Years to first evidence
1
Bottlenecks it attacks

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