OnCo
bottlenecksBottleneck

Trials enrol too few, too slowly

Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.

Around 8% of adults with cancer participate in a treatment trial, and a fifth of trials fail to complete, most often for poor accrual. The barriers are structural before they are personal: most patients are treated at community practices with no open trial, eligibility criteria exclude patients with brain metastases, organ dysfunction, prior cancers or HIV, travel and time costs fall on patients, and physicians have no time or incentive to screen and refer. When a trial is actually offered, more than half of patients say yes. Slow accrual lengthens trials, raises costs, delays answers and kills questions that industry will not fund. Broadened eligibility, decentralised and community-based trial infrastructure, automated matching from the electronic record, and paying patients' costs are the fixes with evidence.

criticaltrials60 ideas to fix it
How big the problem is
~8%
Adults with cancer participating in treatment trials (US, meta-analysis)
55%
Patients who agree to participate when a trial is offered to them
~20%
Adult cancer trials in ClinicalTrials.gov that failed to complete, most often for poor accrual
Root causes
  • Most patients are treated in community settings where no relevant trial is open.
  • Restrictive eligibility criteria exclude a large share of real patients for reasons unrelated to safety.
  • Travel, lost income and out-of-pocket costs fall on patients and are rarely reimbursed.
  • Physicians lack time, incentives and tools to identify eligible patients.
  • Trial activation takes months per site because of contracting and ethics review, so windows of opportunity close.
What is already being tried
  • ASCO and Friends of Cancer Research broadened eligibility recommendations have been adopted in FDA guidance on brain metastases, organ dysfunction, prior malignancy and HIV.
  • The NCI Community Oncology Research Program (NCORP) brings NCI trials to community practices across the US.
  • AI-based trial matching from the electronic record (Tempus, TrialJectory and others) screens patients continuously.
  • FDA guidance on decentralised clinical trials (2023) allows remote visits, local labs and telehealth consent.
  • Just-in-time site activation models and central IRBs cut the months of set-up before a site can enrol.
  • Programmes that reimburse patient travel and lodging (for example, Lazarex Cancer Foundation) directly remove the cost barrier.
What breaking it looks like
At least a quarter of adults with cancer are enrolled in a trial, eligibility criteria are justified by safety alone, and median phase 3 accrual time halves so that fewer than 5% of trials close for poor accrual.

Ideas to fix it

60top
speculativeregulatormedium cost
A global first-in-human network for academic cancer trials with single ethics review

Academic first-in-human trials recruit slowly because each hospital repeats ethics and regulatory review. A network of phase 1 units with one shared review would open trials in many countries at once.

speculativeengineeringlarge cost
A global open trials operating system any hospital can plug into

Build the shared software, legal templates and data standards that let any hospital in the world join a cancer trial in weeks instead of years, the way the internet let any computer join the network.

speculativeengineeringmedium cost
A live 'seats available' feed for trial slots, like airline inventory

Trial registries say a study is 'recruiting' long after it stopped, and never say whether a slot is actually open this week. A live feed of open slots per arm and site would let clinicians refer with confidence.

speculativeclinicsmall cost
A mandatory trial line in every tumour board recommendation

Every time a team of specialists meets to plan a patient's treatment, they would have to record whether a trial exists for that patient and, if so, why it was or was not offered.

being tested at scalepolicylarge cost
A national platform trial that every ctDNA-positive patient can join

Blood tests can now find leftover cancer months before scans, but most patients who test positive have nothing to enrol in. One standing trial per country would fix that.

early clinicalpolicylarge cost
A permanently funded international network for randomised cancer surgery trials

Surgery cures more cancer than any drug, yet most operations have never been compared in a proper trial. A standing network of hospitals, with core funding, would run those trials continuously.

speculativedatasmall cost
A public map of trial deserts to steer where new sites open

Combine cancer incidence with the location of open trials to show which regions have many patients but no trial within an hour's drive. Sponsors and funders would use it to decide where to put sites.

early clinicaldatamedium cost
A shared library of pooled control arms to shrink and speed future trials

Thousands of patients have received standard treatment in the control arms of past trials. Pooling their anonymised data would let new trials borrow from them and randomise fewer patients to old treatments.

being tested at scalephilanthropylarge cost
A standing platform trial for every major cancer, funded as infrastructure

Rather than building a new trial from scratch for every drug, keep one permanent trial open per cancer where new treatments can be slotted in and dropped out, sharing the same patients, control group and infrastructure.

speculativeresearchlarge cost
A standing platform trial that assigns treatment by how the tumour escaped

Instead of a new trial for each resistance mechanism, one continuous trial could sort patients into arms based on the reason their last treatment failed.

speculativepayermedium cost
An asynchronous expert second opinion for every new advanced-cancer diagnosis

Every patient newly diagnosed with advanced cancer would have their records reviewed by an expert centre within a week, without travelling. The review often changes the plan.

speculativeregulatorsmall cost
At least a third of pivotal-trial sites in community and rural settings

Most cancer patients are treated outside big academic hospitals, but most trials are run inside them. Requiring a share of sites to be community practices would bring trials to where patients are.

early clinicalindustrymedium cost
Borrow from past control arms to shrink the control group in phase 3

When the standard treatment has been given to thousands of similar patients in earlier trials, a new trial could randomise fewer people to it and lean on that history, as long as the old data still matches.

early clinicalregulatorsmall cost
Brain metastases included by default in every solid-tumour trial

Up to a fifth of people with advanced solid tumours have cancer in the brain and are usually barred from trials. Letting in those whose brain disease is treated, stable or symptom-free would widen trials and tell us whether drugs work in the brain.

early clinicalclinicsmall cost
Broad research consent as a routine step of the cancer pathway

Every newly diagnosed patient would be asked, as part of standard care, whether their data and leftover tissue can be used for research, so researchers never have to go back and ask.

early clinicalphilanthropymedium cost
Community health workers and trusted local organisations paid to recruit for trials

People join trials when someone they trust explains them. Paying community health workers, churches and local groups to inform and refer people would reach communities that hospitals do not.

speculativeindustrymedium cost
Competing sponsors share one control arm in the same indication

Three companies testing three drugs against the same standard treatment each recruit their own control group. Pooling those controls in one shared study would need fewer patients and answer faster.

early clinicalregulatorsmall cost
Default-inclusive eligibility: sponsors must justify every exclusion criterion

Trials should let people in unless there is a scientific or safety reason to keep them out. Every exclusion rule would need a written reason, reviewed like the rest of the protocol.

early clinicalindustrysmall cost
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.

early clinicalindustrysmall cost
Drop the 'must speak English' rule: translated consent and questionnaires as standard

Many trials quietly exclude people who do not speak the local language because consent forms and questionnaires exist only in that language. Providing translations and interpreters for the commonest languages would fix this.

speculativeclinicsmall cost
Evening and weekend trial clinics for working-age patients

Trial visits happen on weekdays during working hours, which excludes many people with jobs or caring duties. Running research clinics in the evening and at weekends is a simple test of whether that matters.

being tested at scalepolicysmall cost
Every patient is asked once at diagnosis whether researchers may contact them

At diagnosis, people would be asked a single question: may we contact you about research that fits your cancer? Those who say yes would be findable by trial teams without repeated cold approaches.

being tested at scalepayermedium cost
Every payer covers routine care costs for trial participants, in every country

In many places, joining a trial can leave the patient or hospital paying for the ordinary care that goes with it. Making all insurers and public systems cover those costs removes a hidden barrier.

early clinicalindustrysmall cost
Every tumour sequencing report lists open, nearby, matched trials pulled live

The report that tells a patient their tumour's mutations should also tell them which trials are recruiting for those mutations within reach, with the status checked that week rather than copied from a stale list.

early clinicalindustrysmall cost
Fix the neutrophil count rule that excludes many people of African ancestry

Many healthy people of African descent have naturally lower white-cell counts because of a common genetic variant. Trials use a single cut-off that wrongly labels them unfit, so they are turned away. The rule should be adjusted for this variant.

speculativeresearchsmall cost
Guidelines list the open trials at every decision point, updated monthly

Treatment guidelines tell doctors what to do at each step but rarely which trials are open for that step. Adding a live, monthly-updated list to each decision node would put trials where doctors look.

early clinicalindustrymedium cost
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.

early clinicalindustrymedium cost
Just-in-time site activation: open a site in two weeks when a patient appears

Instead of opening a trial at fifty hospitals and waiting for patients, keep a network of pre-vetted clinics ready and switch a trial on where a matching patient is found.

speculativeregulatorsmall cost
Kidney and liver impairment dosing studies completed before approval, not years after

Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one.

early clinicalphilanthropymedium cost
Lay trial navigators funded per centre, evaluated in a randomised trial

A trained non-clinical guide who explains trials, arranges logistics and keeps in touch could make the difference between a patient hearing about a trial and actually joining one.

speculativephilanthropymedium cost
Mobile research units bring trial visits to rural towns

A van equipped for blood draws, ECGs, questionnaires and drug hand-over could visit rural towns on a schedule so trial participants there do not have to travel hours each cycle.

speculativeregulatorsmall cost
Mutual recognition of ethics review across countries

A trial approved by a qualified ethics committee in one country would not need to repeat the full review in another; the second country would accept the first review and check only local issues.

speculativeregulatormedium cost
One clinical trial application accepted by regulators in every major region

Starting a cancer trial in ten countries means ten applications and ten ethics reviews. One shared application and a common ethics template would start trials months sooner.

early clinicalpolicysmall cost
One national master contract and budget template for all cancer trials

Contract negotiation between a hospital and a drug company often takes longer than the trial's first patient. A single pre-agreed contract and budget template, used by everyone, would cut months off opening a trial.

being tested at scalepolicylarge cost
One standing umbrella trial for all rare cancers in a country

Rare cancers together are a fifth of all cancers, but each is too small for its own trial. One permanent trial with many arms would give all of them a route.

early clinicalengineeringmedium cost
Patients are told which trials they qualify for at every treatment decision, in writing

At each point where treatment is chosen, software checks the patient's record against open trials and the clinician must note which were discussed, so trials stop being something only some people hear about.

speculativeclinicsmall cost
Pay investigators for finishing and publishing trials, not for enrolling patients

Trial sites are paid per patient recruited, so nobody is paid to finish the study or report the answer. Shift part of the payment to completion and publication within a year.

speculativepayermedium cost
Pay oncologists for the time it takes to enrol a patient

Discussing and enrolling a patient in a trial takes an oncologist far longer than prescribing the usual treatment, and they are not paid for it. Paying for that time would remove a quiet disincentive.

speculativepolicymedium cost
Pay trial participants for their time, not only their expenses

Trial visits take hours and cost people wages. Paying a fair hourly rate for time spent beyond normal care would make trials possible for those who cannot afford unpaid days off.

early clinicalclinicmedium cost
Point-of-care randomisation built into the oncology record

When two accepted treatments are equally reasonable, the computer system would offer to randomise the choice and track the result, turning ordinary care into a continuous trial.

early clinicalresearchlarge cost
Pragmatic trials in patients over 75 with function, not just survival, as the primary endpoint

For a frail 80-year-old, staying independent may matter more than living a few months longer. Trials designed for older patients should measure what they care about.

early clinicalresearchmedium cost
Pre-consented cohorts that can be randomised to future trials (TwiCs)

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.

speculativeregulatorsmall cost
Publish why patients were screened out of each trial

Trials record why each screened patient did not join, but that data is never shared. Publishing it would show which rules block the most people and which are pointless.

early clinicalresearchmedium cost
Randomise inside the cancer registry: registry-based trials for everyday questions

National cancer registries already collect the outcome data. Adding a randomisation button lets doctors compare two standard treatments across thousands of patients at a fraction of the usual cost.

speculativeresearchlarge cost
Registry-based randomised MCED trial: a million people, no study visits

Randomise people through the national health system, post the blood kit, and read cancer deaths off the registry. That is ten times cheaper per participant than a classic trial.

early clinicalresearchmedium cost
Registry-based randomised trials for oncology comparative effectiveness

Use the cancer registry itself as the trial machine: randomise patients at diagnosis, then let the registry collect the outcomes for a fraction of the usual cost.

early clinicalclinicsmall cost
Remote consent and tele-screening so the first trial visit is a video call

Much of trial screening is paperwork, questions and reviewing scans that already exist. Doing this by video and electronic consent before any travel would let patients decide without a wasted trip.

speculativeindustrysmall cost
Remove blanket exclusions for mental illness and dementia; support consent instead

People with serious mental illness or dementia are routinely excluded from cancer trials, though they get cancer just as often and do worse. Supported consent and reasonable accommodations would let many take part.

speculativeindustrysmall cost
Replace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholds

Most trials use the same blood-test cut-offs for kidney and liver function regardless of how the drug is cleared from the body. Setting the cut-off from the drug's own pharmacology would let many more people join safely.

early clinicalindustrysmall cost
Set trial enrolment targets from who actually gets the disease, and publish progress live

Each trial would set its target mix of patients from cancer registry data on who gets that cancer, by age, sex and ethnicity, and show a public running tally so gaps are visible while there is still time to fix them.

early clinicalregulatormedium cost
Shared concurrent control arms across sponsors' trials in the same setting

When five companies each run a trial against the same standard treatment in the same patients, let them pool the standard-treatment patients so fewer people are randomised to the old drug.

early clinicalindustrysmall cost
Simulate eligibility against real-world data before every protocol is locked

Before a trial is finalised, run its entry rules against records of real patients with that cancer and report what fraction would qualify. If it is under half, explain why.

speculativeregulatorsmall cost
Stop excluding brain metastases from cancer trials

One in five people with advanced cancer has brain spread, yet most trials refuse them. Requiring brain cohorts would give those patients evidence instead of guesswork.

early clinicalindustrysmall cost
Stop excluding people with a prior cancer, controlled HIV, or treated hepatitis

Having had another cancer years ago, or living with well-controlled HIV or hepatitis, still keeps many people out of trials for no good scientific reason. Removing these blanket bans would widen access, especially in communities where these conditions are more common.

speculativeregulatorsmall cost
Stop over-excluding people who could become pregnant; study pregnancy exposure

Trials often impose heavy contraception rules and exclude anyone pregnant or breastfeeding, even when the drug is unlikely to be harmful. Sensible, evidence-based rules and pregnancy registries would include more young women and produce data they currently lack.

speculativeclinicsmall cost
The pathology lab triggers a trial referral the day a rare cancer is diagnosed

The pathologist is the first person to know a cancer is rare or has a targetable marker. A rule in the lab system could notify a trial team at that moment, before treatment decisions close the window.

being tested at scaleindustrymedium cost
Travel, lodging and meals reimbursed as a standard line in every trial budget

People should not have to pay to be in a trial. Sponsors would routinely cover travel, hotel and food costs, paid up front rather than claimed back, which is already accepted by regulators as fair rather than coercive.

early clinicalengineeringmedium cost
Trial matching inside the electronic record at the moment a treatment is chosen

When an oncologist opens the order screen to prescribe a new line of treatment, the record would show the trials this patient may fit, with the nearest open site and a one-click referral.

speculativeresearchmedium cost
Trial-in-a-box: a preconfigured protocol kit any hospital can open for a rare cancer

For rare cancers, the patient is often at a hospital that has no trial. A ready-made kit with the protocol, consent forms, database and shipping already set up would let that hospital enrol them within days.

early clinicalregulatorsmall cost
Two-page plain-language consent with teach-back for every cancer trial and treatment

Replace 30-page consent forms with a short plain summary the patient explains back in their own words before signing, so consent means understanding.

Key papers

2top

Connected

91top

Pages like this

not linked directly; found by shared links

technologies

1

companies

1

institutions

17

terms

2

ideas

60
A global first-in-human network for academic cancer trials with single ethics reviewA global open trials operating system any hospital can plug intoA live 'seats available' feed for trial slots, like airline inventoryA mandatory trial line in every tumour board recommendationA national platform trial that every ctDNA-positive patient can joinA permanently funded international network for randomised cancer surgery trialsA public map of trial deserts to steer where new sites openA shared library of pooled control arms to shrink and speed future trialsA standing platform trial for every major cancer, funded as infrastructureA standing platform trial that assigns treatment by how the tumour escapedAn asynchronous expert second opinion for every new advanced-cancer diagnosisAt least a third of pivotal-trial sites in community and rural settingsBorrow from past control arms to shrink the control group in phase 3Brain metastases included by default in every solid-tumour trialBroad research consent as a routine step of the cancer pathwayCommunity health workers and trusted local organisations paid to recruit for trialsCompeting sponsors share one control arm in the same indicationDefault-inclusive eligibility: sponsors must justify every exclusion criterionDrop mandatory fresh biopsies where blood or archival tissue would doDrop the 'must speak English' rule: translated consent and questionnaires as standardEvening and weekend trial clinics for working-age patientsEvery patient is asked once at diagnosis whether researchers may contact themEvery payer covers routine care costs for trial participants, in every countryEvery tumour sequencing report lists open, nearby, matched trials pulled liveFix the neutrophil count rule that excludes many people of African ancestryGuidelines list the open trials at every decision point, updated monthlyHome infusion and local blood draws for trial drugs after the first cyclesJust-in-time site activation: open a site in two weeks when a patient appearsKidney and liver impairment dosing studies completed before approval, not years afterLay trial navigators funded per centre, evaluated in a randomised trialMobile research units bring trial visits to rural townsMutual recognition of ethics review across countriesOne clinical trial application accepted by regulators in every major regionOne national master contract and budget template for all cancer trialsOne standing umbrella trial for all rare cancers in a countryPatients are told which trials they qualify for at every treatment decision, in writingPay investigators for finishing and publishing trials, not for enrolling patientsPay oncologists for the time it takes to enrol a patientPay trial participants for their time, not only their expensesPoint-of-care randomisation built into the oncology recordPragmatic trials in patients over 75 with function, not just survival, as the primary endpointPre-consented cohorts that can be randomised to future trials (TwiCs)Publish why patients were screened out of each trialRandomise inside the cancer registry: registry-based trials for everyday questionsRegistry-based randomised MCED trial: a million people, no study visitsRegistry-based randomised trials for oncology comparative effectivenessRemote consent and tele-screening so the first trial visit is a video callRemove blanket exclusions for mental illness and dementia; support consent insteadReplace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholdsSet trial enrolment targets from who actually gets the disease, and publish progress liveShared concurrent control arms across sponsors' trials in the same settingSimulate eligibility against real-world data before every protocol is lockedStop excluding brain metastases from cancer trialsStop excluding people with a prior cancer, controlled HIV, or treated hepatitisStop over-excluding people who could become pregnant; study pregnancy exposureThe pathology lab triggers a trial referral the day a rare cancer is diagnosedTravel, lodging and meals reimbursed as a standard line in every trial budgetTrial matching inside the electronic record at the moment a treatment is chosenTrial-in-a-box: a preconfigured protocol kit any hospital can open for a rare cancerTwo-page plain-language consent with teach-back for every cancer trial and treatment

collections

2

people

6

key papers

2