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Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
Trials that lead to cancer drug approvals enrol predominantly younger, white, fitter patients treated at academic centres in a handful of high-income countries. In pivotal trials supporting US approvals from 2008 to 2018, Black patients made up about 3% and Hispanic patients about 6% of participants, and race was not even reported in a large share of trials; patients over 65 have been under-represented for decades relative to their share of incidence. Pharmacogenomic differences (for example, in DPYD, UGT1A1 and EGFR mutation prevalence), differences in comorbidity, body composition and social context all mean that efficacy and toxicity can differ, and the evidence to know does not exist. The geographic concentration also means most of the world's patients are treated on the basis of trials in populations unlike them. Regulators now require diversity action plans, but enforcement, infrastructure and trust are the real constraints.
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.
Cancer information tools must meet a tested standard: reading age around 12, main languages of the population, audio versions and clear numbers, or they are not certified for use.
Most people with cancer are over 65, but trials mostly enrol younger, fitter people. Requiring a group of older patients, assessed for frailty, in every big trial would show whether the drug works and is safe for those most likely to receive it.
Every newly diagnosed patient gets a named person whose job is to get them through appointments, tests, paperwork and money problems. Insurers should pay for it because it prevents delays and dropouts.
Rank hospitals and companies each year on how well their trial participants match the people with the disease in their area, and use the ranking when deciding who gets public research money and trial contracts.
Combine registry cancer incidence by district with open trial site locations from ClinicalTrials.gov to map the regions where patients live more than an hour from any trial. Sponsors and funders would use it to decide where to open sites and justify site selection in diversity plans.
Most people with cancer are over 65, but most trial patients are younger and fitter. A dedicated fund would pay for trials designed for the patients we actually treat.
Women get more severe side effects than men at identical doses of fluorouracil, several kinase inhibitors and immune checkpoint inhibitors in pooled analyses. Trials should pre-specify sex-stratified drug level and toxicity analyses and, where they differ, run sex-specific dose-finding and label accordingly.
Drugs are processed differently by people with different genetic backgrounds, but doses are set mostly in white and East Asian populations. Every new drug should be studied for how it behaves across ancestries, with dosing advice by genotype rather than by race.
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.
Genetic risk scores were built mostly on Europeans and work worse in others. Funding non-European cohorts and setting a portability standard would prevent screening that widens inequality.
Seven in ten cancer deaths are in poorer countries, yet almost all trials happen in rich ones. Funders would commit a share of money for trials designed and led where the burden is.
Black women in the United States have about twice the odds of a triple-negative diagnosis and, in the UK POSH cohort, worse survival than White women despite equal chemotherapy use. The pivotal trials enrolled few of them. Enrolment targets tied to incidence, reported by ethnicity in every primary paper, would make the evidence match the disease.
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.
The rules that decide who gets a lung scan count cigarettes. A risk model that also uses age, sex, family history, deprivation and lung disease would find more cancers in the same number of scans, and would stop excluding people who smoke less but are more likely to get the disease.
Trials usually take only patients who are up and about most of the day. Those who spend more time resting, a common group in real clinics, are excluded, so nobody knows how to treat them. A dedicated group in each trial would answer that.
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.
Companies now have to file a plan for enrolling a representative mix of patients. If the trial misses the plan, the label should say so and the company should be required to fill the gap after approval.
Trials quietly exclude people who do not speak the local language because consent forms and questionnaires exist only in that language. Sponsors should provide validated translations for any language spoken by at least 5 percent of the catchment and fund interpreters; translations of common instruments already exist for dozens of languages.
The one UK study to look found young Black women had more triple-negative breast cancer and worse survival than White women despite equal chemotherapy, but it ended in 2008 and covered women under 41. Routine cancer statistics could report triple-negative incidence, stage and survival by ethnicity every year; at present they do not.
Trial visits happen on weekdays during working hours, which excludes people with jobs or caring duties, so trials under-enrol patients under 65. Running research clinics in the evening and at weekends, cluster-randomised across one network for a year, is a cheap test of whether that matters.
A majority of people of West African ancestry carry the Duffy-null variant, which lowers baseline neutrophil counts without raising infection risk. Trials apply a single neutrophil cut-off that wrongly labels them unfit, so protocols should use Duffy-specific thresholds; Duffy status is a cheap blood test.
Patients are more likely to join a trial when the doctor offering it looks like them or works in their community. Funding more such doctors to become trial leaders would change who is enrolled.
Most cancer patients are over 65, yet treatment is chosen by age and guesswork and trials exclude them. Assess fitness properly and design trials that include real older patients.
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.
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.
Teenagers with cancers that are really adult cancers, like melanoma or sarcoma, are barred from adult trials by an age line at 18. Letting them in from age 12, where biology and dosing allow, would give them access years earlier.
Pack-year rules miss people who get lung cancer without heavy smoking, including East Asian women who never smoked, as Taiwan's TALENT study showed. Eligibility by a validated risk model with a set threshold, plus a never-smoker arm where family history matters, would find more cancers per scan.
Most cancer patients are over 65 and a large share have other illnesses, yet trials routinely exclude them on organ function, prior cancers, HIV or brain metastases. Regulators should require sponsors to justify each exclusion, include patients with controlled comorbidities by default, drop upper age limits, and report enrolment over 75 in labels.
Older, frailer and sicker patients are usually kept out of trials but make up most of those treated. Require companies to report how these patients do in practice.
Every AI tool would have to report how well it works for women and men, different ethnic groups, ages, scanner types and hospitals, not just an overall score.
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.
Japan and China have often required extra local studies before accepting a global trial. Committing to accept well-designed global trials would bring drugs to Asian patients years earlier.
Before a trial is finalised, a paid panel of patients and community members from the groups the trial needs would review it and could require changes to visit schedules, procedures and materials that would deter people like them.
Instead of excluding sicker patients entirely, trials would run a side group for them, receiving the new drug with closer monitoring, so we learn how it behaves in the people who will actually get it.
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.
Labs usually use whichever tumour models they already have. A searchable index that finds the model closest to a specific patient's tumour would make experiments more relevant.
Most of the world's cancer patients live in countries that host almost no registrational trials. Including sites there, and paying to build them up, would make results apply globally and speed local access.
Once a drug is in wide use, real-world records could be checked routinely for whether side effects differ by ancestry or sex, since trials were too small in those groups to notice. Findings would go into the label.
A drug's label should say plainly how well the people in its trials matched the people who get the disease: 'Black patients were 4 percent of participants and 22 percent of cases.' Doctors and patients can then judge how far to trust the result.
People with serious mental illness or dementia are routinely excluded from cancer trials by vague compliance clauses, though they get cancer just as often and do worse. Replacing those clauses with assessable criteria, and funding supported consent and accommodations such as longer visits, would let them take part.
When Black and white men in the United States are given the same treatment, the gap in dying of prostate cancer largely closes. The gap in dying of everything else does not. Cancer services measure the first and not the second, which means the surviving disparity is invisible to the people best placed to act on it.
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.
People who grew up in East Asia, Eastern Europe or Latin America keep a high stomach cancer risk after migrating. Cheap blood tests could select who needs an endoscopy.
Having had another cancer years ago, or living with controlled HIV or treated hepatitis, still keeps patients out of trials for no scientific reason. Condition-specific rules, as FDA guidance recommended in 2020, would replace blanket bans and widen access 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.
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.
About one lung cancer in five happens to someone who never smoked, and they are outside every screening programme in the world. The genomes show it is a different disease that grows more slowly, which is exactly the kind of cancer a screening test could catch.
Poorer patients with lung cancer are less likely to be offered surgery or chemotherapy, at the same stage, in systems that are free at the point of use. That is a fixable problem in how care is delivered, not a fact about the disease.
In a clinical trial the experimental drug is free to the patient and the payer, and since 2022 Medicaid must cover routine trial costs like Medicare and private plans do; pointing more patients to trials lowers bills as well as advancing science.
For the first time a new drug has beaten pembrolizumab, the global first-line standard, in a randomised lung cancer trial, and it did so by combining checkpoint blockade with anti-angiogenesis in one molecule. For patients outside China nothing changes yet: the drug is not approved in the West, the trial was single-country, and survival benefit has not been shown. If confirmed in the global HARMONi-3 and HARMONi-7 trials, PD-1 x VEGF bispecifics could replace PD-1 antibodies as the immunotherapy backbone.
The authors' conclusion is that ibrutinib-rituximab should be considered a new standard-of-care option for first-line treatment of older patients with mantle-cell lymphoma. The subgroup split means it is clearly better than R-CHOP and roughly equivalent to bendamustine-rituximab.
Patients with advanced synovial sarcoma, a rare cancer of young adults with few effective drugs, now have an approved cell therapy that produces responses lasting about a year in a substantial minority, if their tissue type and tumour antigen match. It proves that engineered T cells can work against a solid tumour when a good target is present, which had been elusive. It is not a cure for most, requires specialised centres, and only a minority of patients are eligible.
The document that defines who is offered a scan in the United States, and therefore the document any argument about the screening eligibility gap has to engage with. Eligibility is still defined by pack-years and years since quitting rather than by an individual risk estimate.
The evidence base for setting the age at which screening starts by risk rather than by birthday. It is also a warning: the same score performs differently across ancestries, so a risk model built and validated in European cohorts will under-serve the men at highest risk.
The disparity in prostate cancer death among Black men in the United States is, stage for stage and treatment for treatment, largely a disparity in getting standard care rather than in tumour biology. The disparity that survives equal access is in dying of everything else, which is the part a cancer service is least organised to fix and most able to measure.
One bottleneck page and 14 idea pages on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
The clearest published demonstration that a screening eligibility rule can be accurate on average and systematically wrong for a group. It is the empirical core of the argument for replacing pack-year thresholds with individual risk models.
Shares 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, Drop the 'must speak English' rule: translated consent and questionnaires as standard, Mobile research units bring trial visits to rural towns.
Shares Make sponsors justify every trial exclusion of older and multimorbid patients, Parallel real-world cohorts for sicker patients alongside every pivotal trial, A mandatory over-70s cohort with geriatric assessment in every pivotal trial, Geriatric assessment by default for every older patient, and trials that admit them.
Shares Barbara Ann Karmanos Cancer Institute, O'Neal Comprehensive Cancer Center at UAB, UC Davis Comprehensive Cancer Center, University of New Mexico Comprehensive Cancer Center.
Shares A paid patient navigator for every new cancer diagnosis, reimbursed as a service, VCU Massey Comprehensive Cancer Center, Ethnicity-stratified outcome reporting for triple-negative breast cancer in NHS cancer statistics, Ethnicity and outcome of young breast cancer patients in the United Kingdom: the POSH study.
Shares Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry, Update on triple-negative breast cancer disparities for the United States: A population-based study from the United States Cancer Statistics database, 2010 through 2014, Pivotal trials include sites in Africa, South Asia and Latin America, sponsor-funded, Close the gap between who gets triple-negative breast cancer and who is in its trials.
Shares Audre Lorde, Jane Cooke Wright, Chadwick Boseman, Decentralised trial.
Shares A health-literacy certification standard for oncology portals, letters and apps, Paid community advisory boards with power to change protocol burden, Audre Lorde, A paid patient navigator for every new cancer diagnosis, reimbursed as a service.