When drug trial participation isn’t properly represented by gender, race, ethnicity and socioeconomic status, important distinctions in how treatments may work, in different types of people, will inevitably be missed.
You might think that when a disease strikes a particular group of people harder than the rest of society that that group would be overly represented in medical trials designed to cure the disease. Well, it is unfortunate, but you’d be wrong.
Even though African-Americans suffer from diabetes at almost twice the rate as whites, black patients have been far less likely to be included in drug safety trials, a recent study suggests.
According to a new study in The Lancet Diabetes and Endocrinology, researchers looked at seven completed diabetes drug trials since 2008 to test for cardiovascular safety. In five of those trials, black people made up less than 5 percent of the patients.
“In the United States the burden of diabetes and the serious complications associated with it fall unfairly on minorities, particularly African Americans, yet it appears that they are under-represented in clinical trials of new therapies and devices,” said study co-author Dr. David Kerr of the William Sansum Diabetes Center in Santa Barbara, California
While 13 percent of African-Americans in the U.S. are diagnosed with diabetes, compared to 7.6 percent of Caucasian Americans clinical studies don’t represent that reality. Death rates from cardiovascular disease are also disproportionately high among African-Americans, yet the majority of cardiovascular studies in recent decades have focused on white heterosexual males.
Such lack of diversity in clinical trials has been a disturbing reality that has been going on for decades. In 1996 study on participation in the Journal of the National Medical Association offered four main reasons why so few black folk are involved in such clinical trials: lack of awareness about the trials, economic factors, communication issues, and mistrust. Sixty-eight percent of respondents in that study noted that they might participate in such trials if asked to, with the rationale being to improve the quality of life of others, benefit themselves or others, and obtain free health care and medication.
“However, responses to the open-ended questions indicated that the patients feared clinical trials, did not want to be treated like ‘guinea pigs’ (which they associated with trials), lacked trust in the medical system, and felt blacks were not being approached for enrollment in a proper manner,” the researchers stated.
When drug trial participation isn’t properly represented by gender, race, ethnicity and socioeconomic status, important distinctions in how treatments may work in different types of people can be missed, said Dr. Keith Ferdinand, of Tulane School of Medicine in New Orleans. “Certain groups of patients may respond differently to the same therapies.”
And the examples are not related to diabetes alone. For example, studies have found two types of blood pressure drugs don’t work as well in black patients as other people, and one medicine for heart failure works very well in black patients but not in white patients, Ferdinand said.
