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.
- 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.
- 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Replace 30-page consent forms with a short plain summary the patient explains back in their own words before signing, so consent means understanding.
AGILE showed that for the roughly 6-10% of AML patients with an IDH1 mutation, a targeted doublet produces survival in the range of two years, an outcome previously unimaginable in unfit patients. Ivosidenib-azacitidine is approved and is one option alongside venetoclax-azacitidine for these patients. Which regimen, or triplet, is best for IDH1-mutated disease has not been settled by a randomised trial.
Patients are not the bottleneck; trial access is. Bringing trials to community practices, loosening restrictive eligibility criteria and reducing site burden would do more for enrolment than patient education. Trials today reflect the minority of patients who happen to be treated where trials exist.
Pages like this
not linked directly; found by shared links- BottleneckTrials do not represent the people who get cancer
Shares Pay trial participants for their time, not only their expenses, Travel, lodging and meals reimbursed as a standard line in every trial budget, At least a third of pivotal-trial sites in community and rural settings, Community health workers and trusted local organisations paid to recruit for trials.
- BottleneckTrial design, endpoints and cost
Shares Point-of-care randomisation built into the oncology record, Pragmatic trials in patients over 75 with function, not just survival, as the primary endpoint, Publish why patients were screened out of each trial, Registry-based randomised trials for oncology comparative effectiveness.
- TermReal-world evidence
Shares Point-of-care randomisation built into the oncology record, Simulate eligibility against real-world data before every protocol is locked, Registry-based randomised trials for oncology comparative effectiveness, A shared library of pooled control arms to shrink and speed future trials.
- BottleneckOlder and multimorbid patients are excluded and undertreated
Shares Pragmatic trials in patients over 75 with function, not just survival, as the primary endpoint, Kidney and liver impairment dosing studies completed before approval, not years after, Replace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholds, Alliance for Clinical Trials in Oncology.
- BottleneckData silos
Shares Broad research consent as a routine step of the cancer pathway, Point-of-care randomisation built into the oncology record, A live 'seats available' feed for trial slots, like airline inventory, Trial matching inside the electronic record at the moment a treatment is chosen.
- BottleneckPatients lack understanding, navigation and agency
Shares Two-page plain-language consent with teach-back for every cancer trial and treatment, Patients are told which trials they qualify for at every treatment decision, in writing, Susan Love, Tempus AI.