Consent document translation expense hinders inclusive clinical trial enrolment.

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

Pre-existing cardiovascular disease is associated with an increased risk of cardiovascular events during Bruton tyrosine kinase inhibitor therapy.

The association between pre-existing cardiovascular disease (CVD) and the development of cardiovascular adverse events (CVAE) during Bruton tyrosine kinase inhibitor (BTKi) therapy is not well established. We compared the rate of CVAE, such as new onset or worsening atrial fibrillation (AF), supraventricular tachycardia, ventricular tachycardia, hypertension, myocardial infarction, and sudden cardiac death, between individuals with and without pre-existing CVD, during BTKi treatment. Secondary objectives were to compare the outcomes of patients treated with first generation BTKi versus second generation BTKi and characterize management decisions. A single-center retrospective review was conducted on patients treated with BTKi from 2013 to 2022 at Beth Israel Deaconess Medical Center. Adjusted logistic regression analyses were performed to evaluate the association between pre-existing CVD and CVAE. In this cohort, 11 out of 54 patients (20.4%) with pre-existing CVD developed CVAE, compared to 11 out of 135 patients (8.1%) without pre-existing CVD [age- and sex-adjusted OR 2.79; 95% CI (1.09, 7.25), P = .03]. Patients with pre-existing CVD had higher odds of developing new or worsening AF [age- and sex-adjusted OR 3.36; 95% CI (1.09, 10.71), P = .03]. Results remained robust after further adjustment of comorbidities, type of BTKi, and baseline medications. These results highlight the need for standardized approaches to prevent and promptly detect CVAE during BTKi treatment, particularly in patients with pre-existing CVD.