Most Clinical Trials Have A Glaring Flaw Before They Even Begin

Black Americans are almost twice as likely to have Type 2 diabetes as white Americans, but they are much less likely to be included in studiesthat test the safety and efficacy of diabetes medication.

The burden of diabetes and its complications falls unfairly on minorities, yet they are underrepresented in major clinical trials of new therapies and devices, said Dr. David Kerr, an endocrinologist and author of an article published in Lancet Diabetes and Endocrinology in January.

Kerr and his coauthor, Charis Hoppe, reviewed data from seven Type 2 diabetes drug trials assessing cardiovascular risk and found that in five of those trials less than 5 percent of the participants were black.

Without data to ensure that drugs can safely and effectively treat black patients, doctors can be put in a bind: They can prescribe what is essentially an untested medication for their black patients, or they can forgo prescribing an untested drug, denying those patients a potentially effective treatment.

Most clinical trials have a diversity problem

Clinical trial research helps scientists, doctors and patients understand whether drugs and devices are safe and effective. Crucially, different people react differently to different drugs. So if your group isnt adequately represented in a clinical trial, theres no way for your doctor to be sure if that medicine will be the right one for you.

Case in point: A common medication used to treat hypertension (angiotensin-converting enzyme, or ACE, inhibitors), was associated with poorer health outcomes for African-American patients in a 2015 study published in the Journal of the American College of Cardiology.

ACE inhibitors had been studied in clinical trials, but those trials had so few black patients that it wasnt clear whether the risk was significant. (This is especially disturbing considering that more than 40 percent of African-Americans in the United States have high blood pressure, compared with about 30 percent of the general population.)

The 2015 study, which included data on nearly 60,000 patients, 47 percent of whom were black, was much more definitive.

What we found was, yes, this is actually real, study author Dr. Gbenga Ogedegbe, of New York Universitys Langone Medical Center, told The Huffington Post. Blacks tend to have poorer outcomes when we initiate therapy with that particular drug, compared to whites.

Why diversity in clinical trials matters

Just because people of different races might react differently to drugs doesnt mean those differences come down to biology.

One of the things is that people always say, Are there genetic differences based on race and ethnicity? Dr. Valerie Montgomery Rice, the president and dean of Morehouse School of Medicine, told HuffPost.

In Rices estimation, probably not. What really starts to show is that there are some racial and ethnic categories that can serve as a proxy for differences, Rice explained.

Those differences, known as the social determinants of health, are the structural factors that influence peoples lives, such as socioeconomic status, education, physical environment, employment, social support and access to health care.

There are some differences based on genes, but there are more differences based on environmental factors, Rice stressed. When you look at disparities, we know that disparities exist, but we also know that whats highly influential are social determinants, whether or not someone is going to be able to get access to medications and access to drugs or interventions.

Barriers to diverse trials

Part of the problem is that white researchers in academic centers tend to recruit white study participants. (Less than 2 percent of principal investigators on National Institutes of Health-funded research project grants are black, according to the NIH).

Every time you make the argument for more inclusion, they argue that its a matter of cost, Ogedegbe said. Indeed,diverse clinical trial cancarry a higher price tag in the short term.

If participants dont live near the trial center, there are transportation and child care costs. Time off can be an issue, particularly if a participant works more than one job.

And then theres the fear, grounded in history, that the African-American community will once again be exploited by researchers.

No matter how many times we have this conversation, the Tuskegee experiment is always and continues to have a significant impact on minority participation, Rice said, referring to a 1937-1972 study in which black men were left untreated for syphilis so doctors could observe the diseases progression.

To overcome those barriers, researchers have to hire study coordinators who are skilled at recruiting minority participants. When I started doing my clinical trials, I had a white coordinator, I had a Hispanic coordinator and I had an African-American coordinator, Rice noted.

The result: Her study had significant minority participation.

Using study coordinators who are already members of a community is one way to build trust. Other ways to improve participation can include building cultural competence among researchers and helping potential study participants understand the benefits of participating in a clinical trial on a personal, community and population level.

It really becomes a trust factor, particularly for persons of color, Rice said.

Regardless of the extra hurdles, increased participation among minorities is critical for improving clinical trialsaccuracy.

We cant afford to be reticent when it comes to including a diverse patient population in clinical trials, Ogedegbe said. The results and the cost of not doing that is much worse.

Industry, government and researchers need to work harder

While President Bill Clintons National Institutes of Health Revitalization Act required federally funded research to include women and minoritiesin 1993, loopholes in the law mean its been loosely enforced.

And industry-funded pharmaceutical drug studies are held to an even lower standard.

I would hold their proverbial feet to the fire, Kerr said of industry, noting that payers (meaning large corporations and insurance companies) should push pharmaceutical companies to do more than the bare minimum to study drugs and devices in diverse populations.

If the payer wont cover a drug that hasnt been rigorously tested on a diverse population, industry might be forced to be inclusive.

If we fail to enforce inclusivity, the future of medicine will continue to be a sphere where only white patients receive the best treatments and, in turn, have the best health outcomes.

The cutting edge in medicine today is looking at precision medicine. All of these precision medicine studies, I dont see blacks in them, Ogedegbe said. Where are we going to be 10 years from now? Well have advanced in what we know, but guess what? Guess who is getting left out? Minority communities.

This reporting is brought to you by HuffPosts health and science platform, The Scope. Like us onFacebookandTwitterand tell us your story:scopestories@huffingtonpost.com.

Read more: http://www.huffingtonpost.com/entry/hypertension-drug-clinical-trial-diversity_us_58ab73d4e4b0a855d1d8fc63?ppw7rotbf6qn6ogvi&ncid=inblnkushpmg00000009

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