Trials do not represent the people who get cancer

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 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.

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 experience more severe side effects from many chemotherapy, targeted and immune drugs than men at identical doses. Trials should analyse drug levels and side effects separately by sex and test whether women need different doses.

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.

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.

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.

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.

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.

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 many people who get lung cancer, including East Asian women who never smoked. A risk score with family history and ancestry would find more cancers per scan.

Most cancer patients are over 65 and many have other illnesses, yet trials routinely exclude them. Regulators should require sponsors to justify each exclusion, so the evidence matches the patients.

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, though they get cancer just as often and do worse. Supported consent and reasonable accommodations would let many take part.

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 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.

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.