American Minorities Are Grossly Underrepresented in Medical Clinical Trials — which Demonstrates (again) How Little the Medical Establishment Actually Cares about Being Soundly Scientific

07 April 2014

Citation — to study

Selwyn Vickers, Mona Fouad, andMoon S. Chen, Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual, Cancer 120 (Supplement S7): i–ii, DOI: 10.1002/cncr.28618 (01 April 2014)

Citation — to press release

Dorsey Griffith, Minority clinical trials participation and analysis still lag 20 years after federal mandate, UC Davis Health System (18 March 2014)

Main findings

From the press release:

Twenty years after Congress mandated that research funded by the National Institutes of Health include minorities, less than 5 percent of trials participants are non-white, and less than 2 percent of clinical cancer research studies focus on non-white ethnic or racial groups, UC Davis researchers have found.

Clinical trial participation is low for all adult groups (3 to 5 percent), and the percentage of minorities who participate in clinical trials is not representative of the U.S. population affected by cancer.

For example, blacks experience the highest incidence of cancer (593.7 cases per 100,000 people) but, along with Hispanics, have the lowest rates of cancer clinical trials participation at 1.3 percent.

Methods

From UC Davis:

Chen and his colleagues searched ClinicalTrials.gov, the official NIH website for all registered clinical trials, and looked for trials sponsored by the National Cancer Institute available during the month of January 2013.

They searched using terms for different minority groups then counted the number of clinical trials with a primary focus on a particular ethnic or minority population. They found that only about 150 trials, out of about 10,000, or less than 2 percent, met the criteria.

They also reviewed abstracts and articles accessed from January through March 2013 on PubMed, a comprehensive online database of published research findings, to find articles that specifically examined minority accrual in clinical trials.

Of the 42 citations found, only five included reports explicitly discussing participation levels by race and ethnicity.

Why this matters — These slanted studies bear little relationship to broader reality, which means they are essentially unscientific — given the way that they are ordinarily intended to be used

From NBC News about one year ago:

The latest census numbers show:

The population younger than 5 stood at 49.9 percent minority in 2012.

As a whole, the nonwhite population increased by 1.9 percent to 116 million, or 37 percent of the U.S.

The fastest percentage growth is among multiracial Americans, followed by Asians and Hispanics.

Non-Hispanic whites make up 63 percent of the U.S.;

Hispanics, 17 percent;

blacks, 12.3 percent;

Asians, 5 percent;

and

multiracial Americans, 2.4 percent.

About 353 of the nation's 3,143 counties, or 11 percent, are now "majority-minority."

If everyone were similar genetically, the current emphasis on populating clinical trials with white people would not matter.

But we have known for years that we are not all genetically identical and our culturally acquired health habits also vary. Therefore, incorporating different ethnic types into clinical studies — or assigning them studies of their own — is medically and scientifically necessary.

If these findings are accurate — why hasn’t the study base been appropriately broadened?

Let me be cynical, as my experience with the Medical Establishment has taught me to be. I will hazard a guess that racial bias, institutional complacence, and financial considerations play major roles in this form of discrimination. That last financial element, I suspect, comes from the unconscious realization that many American minorities cannot afford the drugs or treatments that clinical trials might come up with. So, the unconscious thinking may conclude, why bother with them?

And one further — major — caveat

Keep in mind that virtually all clinical trials are numerically too small to accurately tackle the problem of finding statistically subtle medical effects. This means that we cannot find or prove causation because we have included too few people to mathematically demonstrate it with.

With that truth in mind, how accurate do you think these trials’ results are for you — as a non-majority person — when they are based on vanishingly small numbers of your own genetically similar folk?

That’s right. The studies with far too few minority participants are not going to tell us anything reliable about much of anything.

The moral? — If “you” are outside the mainstream of narrowly white-based clinical trials, be cautious about indiscriminately applying their results to yourself

And be sure to raise a fuss about our society’s too casual continuation of the bigotry that discriminates against close to 40 percent of the American population.

The concluding irony is that the Medical Establishment has been yammering about genetically personalized medicine for quite a few years. But it obviously has not gotten up the motivation to get off its metaphorically plush behind to properly structure clinical trials to discover or demonstrate those effects across obviously somewhat different populations.

Hot air is bad enough. Bigoted hot air is worse. When both are emitted under Science’s camouflage, we all lose.

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American Minorities Are Grossly Underrepresented in Medical Clinical Trials — which Demonstrates (again) How Little the Medical Establishment Actually Cares about Being Soundly Scientific