Clinical trial participation rates, including lupus studies, are low in the United States, but considerably worse for underrepresented minorities. Underrepresentation in trials can have far-reaching consequences, which is important because female patients of color with lupus had higher morbidity and death. As a result, for a study, researchers sought to describe the characteristics that impact participation in lupus clinical trials.
The Lupus and Allied Diseases Association, the Lupus Foundation of America, and the Lupus Research Alliance gathered data for their externally driven Patient-Focused Drug Development Initiative in order to better understand and improve participation rates in lupus-related clinical studies. Participants completed a 46-question survey (in English or Spanish) that was provided electronically or on paper at lupus activities. Investigators utilized logistic regression to see if demographic and illness factors were linked to involvement in previous lupus studies.
There were 2,220 responders for whom data was available. Black lupus patients were more likely than White and Hispanic patients to have taken part in previous clinical studies (P<0.05). Hispanic respondents were also more likely to have participated than White respondents, albeit the difference was not statistically significant (odds ratio, 1.40; 95% CI, 0.96–2.11). Both demographic (race/ethnicity) and medical (disease severity defined as higher organ involvement) characteristics appear to play a role in clinical trial participation (P<0.05). When the findings of the study and other studies were combined, it gave insight into recruiting techniques for historically underrepresented minorities.