Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Cette étude examine, pour les nouveaux anticancéreux approuvés par la "US Food and Drug Administration", l'association entre la pertinence de la représentation démographique des groupes de minorités dans les essais cliniques pivots et les délais de développement
Ensuring demographic representation in clinical trials supporting new oncology drug approvals by the US Food and Drug Administration (FDA) is essential, considering the disproportionate burden certain diseases pose to older adults (≥65 years) and racial and ethnic minoritized populations. Drug sponsors conducting pivotal trials often recruit participants from high-enrolling sites, which may not serve minoritized populations, and include international sites, which may not represent the relevant US patient population. Women, older adults, and certain racial and ethnic groups often face barriers to trial participation (eg, lack of knowledge about trial availability, distrust of recruitment efforts). Some have speculated that requirements to improve representation in clinical trials may lead to longer recruitment time and thus prolong novel product testing and development. We evaluated whether FDA-approved novel cancer therapeutics supported by pivotal trials with adequate representation of minoritized groups were associated with slower clinical development times than those with inadequate representation.
JAMA , article en libre accès, 2022