{"entity":{"id":"idea-tr1-pre-consented-cohort-randomisation","kind":"idea","name":"Pre-consented cohorts that can be randomised to future trials (TwiCs)","aka":[],"tldr":"Patients join a long-term cohort once and agree in advance that they may be offered new treatments as they appear, while others in the cohort serve as the comparison group. No new trial has to start from zero.","summary":"The 'trials within cohorts' (TwiCs, or cohort multiple randomised controlled trial) design enrols a disease cohort with staged consent: patients agree to data collection and to being randomly selected for future interventions; those selected are offered the intervention, the rest continue standard care as controls. Utrecht's UMBRELLA breast cancer cohort has run several such trials. The idea is a cohort per major cancer in each large network.","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":["breast-hr-positive","prostate","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nki"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-enrolment","b-trial-design"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Standing TwiCs cohorts will launch new randomised comparisons with under three months from question to first randomisation and enrol controls at near-zero marginal cost, compared with 12-24 months for conventional trial start-up.","rationale":"Recruitment, consent infrastructure and outcome capture are fixed costs paid once for the cohort. The design also reduces disappointment bias in controls, who are not asked to consent to a treatment they do not receive.","test":"Fund one TwiCs cohort in a common cancer at a national network and report time to first randomisation and cost per randomised patient for the first three embedded trials.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":3},"route":"/ideas/idea-tr1-pre-consented-cohort-randomisation/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"institution":[{"id":"nki","kind":"institution","name":"Netherlands Cancer Institute (NKI-AvL)","route":"/institutions/nki/"}],"bottleneck":[{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}