Internal Medicine

Deliberate strategies improved Black and Hispanic enrollment in a pelacarsen phase 3b trial.

The Lp(a)FRONTIERS EXPANSION randomized phase 3b trial enrolled 422 US Black and/or Hispanic participants with elevated Lp(a) and established ASCVD using tailored design and operational strategies. Sites spanned 103 locations across 21 states/territories and enrollment completed one year early. Randomization was 2:1 to pelacarsen 80 mg monthly versus placebo for 12 months; efficacy and safety results are pending. The report demonstrates that culturally informed site selection, enrollment support, and barrier removal can increase minority trial participation. 1

CDR‑SB most sensitive for 12‑month decline in AD dementia; futility trials appear feasible with enrichment.

In 2,665 ADNI participants (424 with AD dementia), 60.6% with AD dementia worsened by ≥1.0 point on CDR‑SB at 12 months. ADAS‑Cog13 showed 41.7% worsening by ≥5 points at 12 months, while MMSE was less sensitive. Authors conclude Simon two‑stage futility trials are feasible in AD dementia with short (6–12 month) designs and modest sample sizes. MCI trials require longer follow‑up and enrichment by age, APOE ε4, and baseline CDR‑SB to be practical. 2

Pivotal device trials rarely embed equity methods, limiting external validity.

This scoping review of 74 pivotal medical device studies found most were randomized but few integrated EDI into design or analysis. Race/ethnicity was reported in only 35.1% of studies and PROGRESS‑Plus variables in 9.5%, with no use of CONSORT‑Equity. Few studies conducted population benchmarking or acknowledged structural participation barriers. The authors warn limited EDI integration constrains assessment of trial representativeness and applicability. 3