Addressing the Racial Disparity in Clinical Trials

The issue of the racial/ethnic minority disparity, within the clinical trial process, must be differentiated between those reasons that are shared with the general dysfunction that exist within the healthcare access/delivery system and those challenges that are specific to the clinical trial dynamic. To effectuate the fundamental change within the system, obviously, we must identify the chronic intrinsic reasons and implement a methodology which would circumvent these shortcomings. Primarily, the factors that are responsible are predicated on racial/cultural miscomprehension and insensitivity, which are manifold in its manifestation. Essentially these factors are realized in three distinct ways: institutional realities that maintain racial/cultural disadvantages, individual racial/cultural discrimination and biased treatment, and internalized cognitive processes.

One of the profound results of the institutionalization of racial/cultural biases is demonstrated by the preponderance of people of color marginalized by socio-economic factors. One of the major variables in healthcare disparity, as a result of this situation, is the question of affordability. Although the Affordable Care Act is an attempt to ameliorate the problem, unfortunately in many states it hasn’t been realized because of the resistance to Medicaid expansion. Another variable that exacerbates the problem is the community deprivation of an adequate healthcare infrastructure. This in tandem with the former serves as barriers in the access to quality healthcare.

Once the question of access has been resolved, the integrity of the patient-healthcare provider relationship must be considered. If this relationship is characterized by a differentiated socio-cultural value system or a language and/or educational barrier, the potential for a quality experience is precarious. This relationship can be further impugned by the physician’s internalized cognitive process which maybe perverted by racially and/or culturally charged stereotypes.

The aforementioned illustrates the spectrum of issues that impact the access to quality healthcare, for the socio-cultural differentiated patient. The following outcomes are a result of these inequities.

Disparities in quality of care are common:

• Blacks and Native Americans receive worst health care than Whites for about 40% of measures
• Asians received worse care than Whites for about 20% of measures.
• Hispanics received worst care than non-Hispanic Whites for about 60% of core measures
• Poor people received worse care than high income people of about 80% of core measures.

 

Disparities in access are also common, especially among Hispanics and poor people:

• Blacks had worse access to care than Whites for one-third of core measures.
• Asians and Native Americans had worse access to care than whites for 1 of 5 core measures.
• Hispanics had worse access to care than non-Hispanic Whites for 5 of 6 core measures.
• Poor people had worse access to care than high income people for all 6 core measures.

 

Few disparities in quality of care are getting better:

1. Fewer than 20% of disparities that are faced by Blacks, Native Americans, Hispanics, and poor people showed evidence of narrowing.
2. The Asian-White gap was narrowing for about 30% of core measures, the largest proportion of any group, but most disparities are not changing.(AHRQ Archive, 2014)

 

In the realm of the clinical trial experience the aforementioned behaviors are relevant. For example, to date, the majority of clinical trials being conducted have included a very narrow segment of the U.S. population; mostly middle-class, married, white males. Those impediments that preclude diverse population’saccess to quality healthcare also prevail within clinical trial methodologies. In order to circumvent this anomaly, a new paradigm must be established involving clinical trial professionals possessing a cultural competency for the target patient population. These professionals must be included in all facets of drug development; from study design to data analysis. For example, in the conduct of a clinical trial, it’s essential that objectivity supersedes bias. Bias can adversely impact any phase of the clinical investigation from the establishment of a trial objective to the veracity of clinical assessments and diagnosis to data analysis. The presence of a professional with the appropriate racial/ethnic/ cultural sensitivity can minimize this phenomenon.

The socio-economic demographic of the study patient/volunteer is one of many factors that must be taken in consideration in maximizing the clinical trial experience. Considering those that are socially and economically stressed, it isn’t unusual to see these individuals with the presence of many different physiological issues in tandem with psychosocial issues in combination with health illiteracy. All of this existing within a context of a non-mainstream cultural experience. It’s imperative that such a population be recruited and most importantly retain in the clinical trial system. In order to realize this, the patient-centered concept must be employed. If properly implemented, this will encourage patient engagement which will positively affect the patient-investigator relationship. To insure success, cultural relevance between the provider and patient must be effectuated. This will lead to a better efficiency in communication and patient/client participation throughout the duration of the trial.

The inability of the industry to access a more diverse patient/volunteer population is not the result of intransigence on the part of the industry, but the absence of a credible system that would serve as a conduit in terms of providingsuch a population. This can be rectified by establishing a dynamic clinical trial infrastructure of which minority controlled site management organizations (SMO) would be at its foundation. These site management organizations would act as ambassadors within their communities inactively cultivating a relationship with those healthcare, social, economic leaders of the positive outcomes from actively being involved in the clinical trial infrastructure. In order for this to occur there must be an emphasis that a new paradigmhas been established in which the exploitative reputation of the clinical trial, especially within the minority community, has been eliminated. This new model will consist of a greater input from all stakeholders within the community; such as:

• The development of community based institutional review boards (IRB). This type of IRB prototype would serve as a means of familiarizing those within the community to the integral aspects of the clinical trial, but most importantly, it will provide a sense of empowerment in the clinical trial environment
• The development and implementation of patient-centered clinical trials. Because of the socio-economic challenges that are prevalent within this population which exacerbates their issues, a systematic means of increasing a patient’s involvement in the clinical trial environment must be employed. For example, the patient-centered concept encouragesa robust patient consent process, not just insuring that the patient comprehends what’s going to be done to them, but must importantly engage the patient in an extensive dialog as to the why. Most importantly, there must be a focus on the whole person, who possesses individual needs within certain social contexts. We must not only explore the clinical assessments but the feelings and ideas of the patient
• Increasing the network of minority investigators will obviously, generate more potential patients. More importantly, we will have a greater reservoir of investigators to conduct Phase IV post-marketing surveillance trials. This phase of investigation provides an opportunity to scientifically observe the integration of the clinical impact of a pharmaceutical within the unique social context of a diverse population

The essential role of the SMO, of course is to not only to assure the sponsor of the conduct of a trial within compliance, but to provide the necessary support system for the investigator to produce data of which its integrity is beyond reproach. This will be realized by intensely facilitating the investigator and their support personnel in all aspects of the clinical trial process; fromsite/investigator identification and/or development to data analysis. By coalescing the right individuals within the community of a specific population, we can transform them to enthusiastic, knowledgeable stakeholders in the clinical trial process.