In my previous article, I explored the clinical trial archetype largely consisting of a racially and culturally diverse population. This idea is universally embraced among clinical research professionals in order to insure product integrity in the realm of drug development. The myriad of strategies that are professed by regulatory and professional organizations in realizing a diverse participation has been widely explored and touted. Considering the genuine effort and major amount of time devoted to the subject, its incessant persistence to many is nonetheless perplexing. What is the foundational factor that precludes diversity in the clinical trial arena? In order to shed light on this issue, it is important to first determine who the most important stakeholder in the outcome of clinical trials is. Among many clinical research personnel, the general consensus is thought to be the investigator.
It is the well proficient and reputable investigator, in tandem with a well-managed and trained support team, who possesses the clinical and administrative skillset in ensuring that the acquisition of data is not only maximized, but beyond reproach. The fundamental component in realizing such success is the investigator/volunteer relationship. This relationship must be predicated on two-way unequivocal communication and unbiased attitudes, which will eventually lead to mutual respect and trust. To ensure the realization of such a relationship, there must be an appreciation for the differentiated socio-cultural value system and/or language and/or educational barrier that may exist between the investigator/team and the research volunteer. There also must be an awareness of the possibility that the investigator, as well as the volunteer, may possess their own racially and/or culturally charged stereotypes that can easily pervert that crucial investigator/volunteer relationship, thereby increasing the chance of compromising the veracity of any data that’s acquired. The possibilities of these events must be minimized when interacting with a racially and/or culturally diverse population.
Considering the importance of this prospect, it is therefore imperative that efforts at this level be made to diversify the process. In order to rectify the inequities, there needs to be a system that liberates the access to minority investigators. Within the industry, the clinical research associate (CRA) is the most likely candidate in playing a significant role in addressing this issue. The CRA’s access to physicians and the physician’s network will produce ample opportunities to connect with physicians of diverse backgrounds. Through the travels of the CRA, they come in contact with a manifold of opportunities to cultivate relationships with physicians of diverse backgrounds. For instance, by reaching out to organizations that represent the interests of such physicians, such as the American Medical Woman’s Association (AMWA), The Association of American Indian Physician (AAIP), National Council of Asian Pacific Islander Physician (NCAPIP), The National Hispanic Medical Association (NHMA), National Medical Association, and the association of African American physicians (NMA), CRAs can cultivate professional relationships with such a population.
Many such physicians, because of a lack of opportunity, haven’t had the opportunity to hone that necessary skillset to be an investigator. There are a plethora of investigators of racially and/or culturally diverse backgrounds who are very enthusiastic about leading clinical trials. To take advantage of this enthusiasm, the CRA must be empowered with an infrastructure to identify the potential of such novices in being investigators and provide these individuals educational opportunities in the rudimentary concepts in becoming an investigator. There must be a means of incentivizing the CRA in establishing such relationships. When this occurs, a system will be in place to reverse a trend that has impeded sound global research. Once the physician is identified and taught the methodologies in conducting a clinical trial, it’s imperative that a support system be implemented ensuring the long term success of the novice investigator. This will be realized with the implementation of SMOs (Site Management Organizations). These organizations will consist of clinical research personnel who share a cultural relevance with the investigator/team as well as the patient volunteers. The purpose of these organizations is to ensure that the objective of the protocol is realized, and that the multi-faceted procedures, which comprise a clinical trial, are properly executed and systematically evaluated. SMOs will implement clinical trial management systems to effectuate the clinical trial process with optimal efficiency and expediency by providing certified SOPs to the site. One of the primary functions will be to facilitate the investigator in determining budget and cashflow analysis. Considering the financial vulnerability of many minority physicians, the economic realities in conducting a clinical trial can be daunting. Before a potential investigator makes a commitment, it must be predicated on a genuine financial assessment; this increases the probability of a successful experience for both the sponsor and the investigator.
A major inherent within the system that exponentially makes it difficult for the minority investigator, is access to an International Review Board (IRB). IRBs must be decoupled from academic settings and become more community-oriented. Community Based IRBs is a concept that has been in the discussion stage for many years, and it is time to bring it to fruition. One of the essential characteristics of an IRB is that it should reflect the values of the community in which the clinical trial is being conducted. The constituents that are required of an IRB are present in every community and easily satisfy this requirement. All that is required is that they are identified, recruited, trained, and certified. Most importantly having an IRB comprised of members of the community will serve as a step in the right direction in eradicating the mistrust that is persistent within the minority community when it comes to clinical research. A Community based IRB will provide its members with a sense of empowerment and the community at large a sense of participation as opposed to exploitation.
For myriad reasons, the absence of minority patient participation in clinical research has been pervasive and profound; the reasons are manifold and complex. In analyzing the why, we may be overlooking the obvious in resolving the issue. Primarily, there must be a major commitment in recruiting minority physicians in the capacity as investigators. This in turn will manifest patient diversity within the clinical trial experience and potentially lead to more insight into the state of healthcare of such populations, which in turn could lead to a closing of the schism in health disparities.