Call to Action: Overcoming Enrollment Disparities in Cancer Clinical Trials with Modernized Eligibility Criteria
Menée aux Etats-Unis à partir de données 2014-2017 portant sur 198 essais cliniques incluant des patients atteints d'un cancer du pancréas, cette étude analyse le respect des recommandations destinées à moderniser les critères d'éligibilité pour réduire les inégalités d'accès
Traditional clinical trial eligibility criteria restrict study populations, perpetuating enrollment disparities. We aimed to assess implementation of modernized eligibility criteria guidelines among pancreatic cancer (PC) clinical trials. Interventional PC trials in the United States since January 1, 2014 were identified via clinicaltrials.gov with December 31, 2017 as the transition for pre-/post-guidance eras. Trials were assessed for guideline compliance and compared using Fisher’s exact test. In total, 198 trials were identified; 86 (43.4%) were pre- and 112 (56.6%) post-guidance era. Improvements were seen in allowing patients with history of HIV (8.6% vs. 43.8%, p < 0.0001), prior cancer (57.0% vs. 72.3%, p = 0.034), or concurrent/stable cancer (2.1% vs. 31.1%, p < 0.0001) to participate. Most trials (>95%) were compliant with laboratory reference ranges, QTc cutoffs, and rationalizing excluding prior therapies both pre-/post-guidance eras. However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.
JNCI Cancer Spectrum , article en libre accès, 2022