ideasIdea
Pivotal trials include sites in Africa, South Asia and Latin America, sponsor-funded
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.
Regulators and funders expect global pivotal trials to include a minimum share of sites in low- and middle-income countries, with sponsors funding site capacity (training, pharmacy, imaging, data systems) that persists after the trial. Post-trial access to the drug in participating countries is a condition. Latin American and Indian networks have demonstrated high-quality accrual; African oncology trial infrastructure is the least developed and would be prioritised.
Hypothesis
Trials with LMIC sites will enrol faster overall, will produce efficacy and safety data generalisable to those populations, and drugs will be registered and reimbursed in participating countries sooner than in comparable non-participating countries.
Rationale
HIV and malaria trials built durable research infrastructure in Africa; oncology has not. Regulatory approval in LMICs often lags years partly because there is no local data.
What would test it
Track time to local registration and pricing agreements for drugs whose pivotal trials included LMIC sites versus those that did not, adjusting for company and indication.
Maturity
early clinical
Who has to act
industry
Cost to try
Large (over $50M)
Years to first evidence
5
Bottlenecks it attacks
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
- Most of the world has almost no cancer care · Seven in ten cancer deaths happen in low- and middle-income countries, where radiotherapy, pathology, surgery and drugs are scarce.