{"entity":{"id":"idea-tr1-lmic-sites-in-pivotal-trials","kind":"idea","name":"Pivotal trials include sites in Africa, South Asia and Latin America, sponsor-funded","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Trials do not represent the people who get cancer): Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019)","url":"https://doi.org/10.1001/jamaoncol.2019.1870"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial","iarc"],"pathways":[],"terms":[],"trials":[],"people":["barrios-carlos","gupta-sudeep","ilbawi-andre"],"bottlenecks":["b-trial-diversity","b-global-access"],"keyPapers":["paper-loree-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"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.","test":"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","actor":"industry","cost":"large","horizonYears":5},"route":"/ideas/idea-tr1-lmic-sites-in-pivotal-trials/","neighbours":{"institution":[{"id":"iarc","kind":"institution","name":"International Agency for Research on Cancer (IARC / WHO)","route":"/institutions/iarc/"},{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"person":[{"id":"ilbawi-andre","kind":"person","name":"André Ilbawi","route":"/people/ilbawi-andre/"},{"id":"barrios-carlos","kind":"person","name":"Carlos Barrios","route":"/people/barrios-carlos/"},{"id":"gupta-sudeep","kind":"person","name":"Sudeep Gupta","route":"/people/gupta-sudeep/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"}],"paper":[{"id":"paper-loree-jama-oncol","kind":"paper","name":"Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018","route":"/key-papers/paper-loree-jama-oncol/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"},{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}