{"entity":{"id":"idea-tr1-drop-non-essential-biopsies","kind":"idea","name":"Drop mandatory fresh biopsies where blood or archival tissue would do","aka":[],"tldr":"Trials often require a fresh tumour biopsy just to enter, even when the sample is only for research. Classifying each biopsy as essential or research-only, making the latter optional and allowing blood tests or archived tissue for eligibility markers, would remove a painful hurdle that drives refusals.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Trials enrol too few, too slowly): Unger et al., Systematic review of barriers to cancer trial participation (JNCI 2019)","url":"https://doi.org/10.1093/jnci/djy221"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["liquid-biopsy","cgp"],"targets":[],"drugs":[],"companies":["guardant-health","foundation-medicine"],"institutions":[],"pathways":[],"terms":["ctdna"],"trials":[],"people":[],"bottlenecks":["b-trial-enrolment","b-toxicity-qol"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","test":"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","actor":"industry","cost":"small","horizonYears":1},"route":"/ideas/idea-tr1-drop-non-essential-biopsies/","neighbours":{"technology":[{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"}],"company":[{"id":"foundation-medicine","kind":"company","name":"Foundation Medicine (Roche)","route":"/companies/foundation-medicine/"},{"id":"guardant-health","kind":"company","name":"Guardant Health","route":"/companies/guardant-health/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"}],"bottleneck":[{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}