The Systemic Flaw in Clinical Trials
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COMMENTARY

The Systemic Flaw in Clinical Trials

Graeme M. Lipper, MD

Disclosures

October 09, 2020

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This chaotic year got even more controversial this summer after the video-recorded death of George Floyd. The resultant nationwide protests calling for racial justice brought new attention to systemic racism. Sadly, that term has become unnecessarily controversial.

Efforts to address bias in medicine don't seek to point fingers or assign moral blame. Rather, identifying inequities in the quality and delivery of healthcare furthers the goal of us all to provide excellent care to patients from all racial, ethnic, and socioeconomic backgrounds. The objective of programs addressing this pervasive issue is simply to identify areas in which one racial or ethnic group is disadvantaged over others, and try to mitigate it.

Clinical trials are the bedrock upon which evidence-based medicine is built. When treating complex dermatologic conditions, we rely on data from well-designed, appropriately powered, randomized, placebo-controlled, double-blinded phase 3 clinical trials. And in order to be able to provide clinically useful answers for a diverse population, those trials have to reflect the real-world populations being treated.

In this light, a recent cross-sectional study examined whether trials of plaque-type psoriasisare flawed by intrinsic "ethnoracial disparities." The investigators gathered data from 82 completed phase 3 clinical psoriasis trials including almost 50,000 patients.

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