Under-representation of Ethnic Populations in US Clinical Trials

Posted Nov 3, 2010 in

Don’t Bury the Lead. 

As I do most mornings, I began the day, a few weeks ago, by browsing through the news on a local television station’s website. In the Health news, I found an article entitled “Blacks under-represented in Clinical Trials” I found it interesting that of all the reasons listed for the low levels of African-American participation in clinical research studies that the last reason (perceived, by me, as least important) was “…and, some might say, a historic distrust of the medical community”. Wow...my mind is still reeling a bit from what I’m thinking is an under-representation of the entire issue by the reporter, a Medical Doctor, none-the-less. Talk about “burying the lead.”

In my experience there is not an African-American person who will not immediately recall “Tuskegee” when engaged in any discussion of clinical research. The Tuskegee Syphilis Study has been called “arguably the most infamous biomedical research study in US history”¹. The establishment of the Office for Human Research Protections (OHRP), a division of Health and Human Services (HHS), and regulations requiring Institutional Review Boards (IRB) are directly attributable to this study. Forty years of the US government violating nearly every clinical research participant protection we now take for granted. This is the study that “some might say” was solely responsible for the development of the “Informed Consent” process and form; although Oak Ridge can certainly be added as another resultant case. 

At almost the very beginning of my career in the clinical research industry I was introduced to the issue of low participation levels within ethnic populations, specifically within the African-American community. It was when I was asked to develop an enrollment campaign for an extremely large, long-term study of hypertension that I began to receive my true education. Since the study was sponsored by the National Institute of Health (NIH), there was a mandatory African-American participation level. I had already discovered that certain populations respond to medications differently and research studies were supposed to be designed to include those populations with high prevalence rates. Such is the case with hypertension within the African-American community.  What stuck me as strange, though, was the minority population mandate.

As a matter of due diligence I asked a friend of mine, an African-American communication consultant, to assist me with the development of my outreach plan. Treating this as a learning opportunity, I decided the best approach would be to act as a reporter gathering “deep background” material: ask questions that lead to follow-up questions; follow the path no matter where it leads.

I remember as if it were yesterday… giving my friend some background of the current study and the “African-American population mandate”. I opened with a simple question of why would the government feel the need to mandate ethnic participation in a clinical trial? It would seem to me that clinical research study populations would automatically be representative of the percentage of each ethnic group within the general population. The answer came back to me like “the shot heard around the world”… one word… one very curious word.  Tuskegee. 

“Tuskegee?  What’s Tuskegee?”

OK… so I was ignorant, having absolutely no concept of the can of worms I was opening. I began my career in research as a media buyer two years earlier, in 1995, having come from the broadcast industry. I had prided myself on reading everything about clinical research I could get my hands on… joined ACRP and The Drug Information Association (DIA), subscribed to R&D Directions, The Pink Sheet, CenterWatch and other industry publications and was engaged in daily conversation with people in research. How could I NOT have heard of Tuskegee?

Now, fifteen years into my career in developing strategies for clinical trial recruitment and enrollment, the issue of under-representation is still at hand. So what can be done to ensure better clinical research representation within all ethnic groups within the United States? The answers are simpler than one would think. To arrive at conclusions, a quick assessment of the major roadblocks is key.

Within immigrant populations the issues are relatively the same but, for some very different reasons. Heavily based upon extended families, immigrant populations within the US often cite a complete distrust of medical record keeping as an issue in both engaging in regular medical care and participating in research. There is a perception that medical records will be shared among various government agencies, not the least of which is the Immigration and Customs Enforcement (ICE). The primary fear is that tracking of medical records may reveal details about immigration status of themselves, friends and/or family members.

The two primary issues here are trust and comfort, in that order. It is imperative to establish trust with prospective volunteers and develop comfort levels with research team members. 

Based upon my discussions with medical professionals within various ethnic groups, there seems to be a lack of “in-culture” research physicians and staff members with whom the ethnic populations can engage. For most ethnic sub-cultures, trust is established at a much higher rate with those who are from the same culture. In order to communicate the protections established for research participants it is of the greatest importance that the person delivering the message be in-culture with the intended message recipient. Comfort levels are established in the same fashion, but trust must be established before comfort can be obtained.

A change of population-specific perception is required in the development of a communication model between medical service providers and patients. We must provide information based upon easily attributable facts. Let’s engage local clergy and other social groups within the culture. Let’s provide a culturally soothing environment. Most importantly, do not fear the big issues when speaking with a prospective research volunteer… tackle the big issues proactively. Pre-empt the inevitable. The perception of fearlessness establishes a level of trust and comfort with the patient (the patient begins to mirror your behavior). Most importantly, allow your patient to feel they can ask any question without being regarded as less than equal.

Since study coordinators are in the best position to initiate contact and develop peer relationships with patients, a great deal of the communication burden rests on their efforts. The study coordinator is the backbone of successful clinical research and should receive ample communication training.

Trust begins on the first contact so the person answering the phone and greeting the patient on the first office visit and all subsequent contact staff also must be made well aware of potential patient perception.  This is where in-culture physicians, coordinators and ancillary office staff become a highly valuable resource.  We communicate and accept ideas at a much more efficient rate with those whom we most readily identify with and hold in high regard. If we want to break through the Tuskegee barrier, we must first recognize its existence and then develop clinical study strategies to overcome the barrier… beginning with but not limited to, contracting African-American research physicians.  The same goes for other ethnic populations.

“Burying the lead” only serves to further the problem. Open, truly dyadic communication from in-culture researchers will open the door to greater ethnic clinical research participation.

References:

1.    Katz RV, Kegeles SS, Kressin NR, et al. (November 2006). "The Tuskegee Legacy Project: willingness of minorities to participate in biomedical research". J Health Care Poor Underserved 17 (4): 698–715. doi:10.1353/hpu.2006.0126. PMID 17242525. PMC 1780164