She signed the consent form on a Tuesday. By Friday she'd withdrawn, and nothing about the protocol had changed. What changed was a conversation at her kitchen table, where the person closest to her said she shouldn't do it. A patient can be perfectly able to participate and still lose the trial because of who is, or isn't, around them. Research in Psycho-Oncology finds family caregivers are central to the decision to enter an early-phase trial, often supporting the patient's choice while holding back their own fears to preserve the patient's autonomy.
No one to back them
Support system friction is when a patient lacks reliable caregivers, family approval of participation, or community support for follow-through. The support system operates almost entirely where trials stop looking: after the signature, at home, in the weeks between visits. Caregiver disapproval in particular is one of the strongest predictors of consent withdrawal, and it happens after a patient has already signed.
PRISM reads it across five models: caregiver availability, caregiver trial-task support, caregiver approval of participation, family and community approval, and community support density. It separates whether a caregiver exists from whether they'll actually do the trial work, and whether they approve of the decision at all. The response builds the support that isn't there: a family-decision conversation guide, a caregiver onboarding flow, peer-network introductions, and connections to faith communities and patient-advocacy groups.
They're the one doing the caregiving
Caregiving burden friction is the mirror image. Here the patient is themselves responsible for a child, a parent, or another dependent, and trial visits collide with that duty. A parent with no childcare doesn't miss a visit out of indifference. They miss it because there was no one else, and it reads as unreliability when it's really a scheduling conflict no one asked about.
PRISM captures it through the childcare and dependent-care burden model, reading caregiving answers from pre-screening, household composition, and the ages of the patient and any dependents. The response removes the conflict: a childcare voucher, sibling-care support, dependent-care planning resources, and visit scheduling built around the patient's caregiving rather than against it.
No one to carry the care between visits
Care continuity friction is when a patient lacks a stable primary-care or specialty provider who can support the referral, monitor between visits, and continue care after the study ends. A patient with a steady provider has a warm path into a trial and someone to catch what happens between visits. A patient without one is starting cold. Research in Cancer Medicine argues that retention improves when trials focus on the family system, not just the patient, because caregivers provide early detection of simmering symptoms and reliable function reporting at home.
PRISM captures it through the provider continuity model, reading distinct providers seen over time, recency of care, a consistent prescriber, and payer enrollment continuity. The response supplies the continuity that's missing: coordinated specialist referral, payer navigation, an assigned patient navigator, and a communication bridge between the site and the patient's own provider.
The procedures don't fit their body
Functional limitation friction is when a patient has physical, cognitive, or sensory limitations that conflict with trial procedures. The signal is frequently sitting right there in claims and the EMR, and feasibility assessment misses it anyway, so the mismatch surfaces only after the patient has invested in consent.
PRISM captures it through the disability and functional status model, reading relevant diagnosis codes, EMR functional-status indicators, and patient-reported answers about activities of daily living. The response designs for the limitation: accommodation planning by type (mobility, vision, hearing, cognition), procedure-fit screening before the patient commits, and alternative-procedure design where the protocol allows. A trial that says it wants a representative population has to be accessible to one.
You're enrolling a situation, not just a patient
The support frictions are a reminder that a patient arrives with a whole context: the people who back or block the decision, the dependents who need them, the provider who does or doesn't exist, the body that will or won't tolerate the procedures. Reading that context early is what lets a site build the missing support instead of discovering its absence at the first missed visit.
Sources and methodology.
This article synthesizes published research and public benchmarks with Jumo Health's PRISM readiness framework. Statistics are presented with their publication context; trial conditions and patient populations vary.
- Tufts Center for the Study of Drug Development, site enrollment performance benchmarks. View source
- CISCRP, 2023 Perceptions and Insights Study. View source
- Communications Medicine (Nature), 2025, trial representativeness of FDA-approved drugs. View source
- National Assessment of Adult Literacy (NAAL), US Dept. of Education / NCES. View source
- Paasche-Orlow et al., New England Journal of Medicine, 2003, consent form readability. View source
- Johns Hopkins Medicine IRB, informed consent readability guidance. View source
- Journal of Clinical Oncology (ASCO), 2022, travel distance in early-phase trials. View source
- Geographic access to NCI-funded cancer research sites (PMC). View source
- Patient-reported out-of-pocket costs in early-phase oncology trials (PMC). View source
- Pew Research Center, Internet/Broadband Fact Sheet. View source
- FCC, Broadband Progress Report (100/20 Mbps standard). View source
- Kogan et al., Psycho-Oncology, 2022, caregiver role in phase 1 trial decisions. View source
- Cerutti et al., Cancer Medicine, 2025, family system and trial retention. View source
- Tufts Center for the Study of Drug Development, protocol amendment benchmarks. View source
- Trials (Springer), 2025, retention and missing primary-outcome data review. View source
- US FDA, Diversity Action Plans (FDORA 2022). View source
