12 Jan Putting Diversity at the Center of Clinical Trials With Real-World Data

By Jen Lamppa, Applied Clinical Trials

In the realm of clinical research, a highly selective process prevails that favors patients with the financial and social means to participate. Often, inherent biases even influence who is invited to participate in clinical studies. Recent analysis outlines the stark disparities in the clinical study participation of diverse patient segments compared to a disease’s real-world disease demographics. Without diverse patient participation and data collection, clinical researchers are unable to robustly examine any underlying differences in new treatment safety and efficacy. As Nancy Krieger aptly states, “no data, no problem.”

The evidence for expanding diversity and representation

As new treatments reach the market, a problem appears: real-world research shows dissatisfying outcomes and access disparities. One US study reveals that within the early years of a novel interventional device usage, women fare significantly worse than men, even after accounting for underlying differences. Real-world outcomes research aims to uncover and comprehend these biases, like a recent study demonstrating durable outcomes but limited use of CAR-T therapy in older patients. When underlying factors are removed from the equation, the possibility arises that these disparities are driven by inherent bias or patients’ underlying social determinants of health (SDOH). Read more…