Abstract

As much as it is easy to assert that the advancement in medicinal products is possible through an active and effective clinical research. It is also as more important as the former to have good and standard strategies in a clinical trial recruitment process that will represent genetic diversities within a population. Furthermore, this will effectively help to mitigate the challenges of socioeconomic disparities, effectiveness and safety issues that may cloud the use of medicinal products to its intended users. To design a good and effective strategies for any clinical research, researchers must set a recruitment goals (Johnson, Powell-Young, Torres, & Spruill, 2011). The recruitment goal will include diverse ethnic groups without in any way generate an adverse compromise to the inclusion criteria clause (NIH, 1993). However, for the purpose of maintaining good clinical practices, it is very important to generate a scientific data that will be easily applicable to any ethnic group with less adverse event. To achieve a better recruitment methodology, it is important to maintain a face to face value strategies whereby representative in clinical research must target specific ethnic groups by using the following; community–based, population-based, supplemental-based and other additional recruitment-based systems (Johnson, Powell-Young, Torres, & Spruill, 2011).

Increasing the Level of Participation in Clinical Trials

Based on the historical events of medical maleficence that has plagued clinical research over the years, it is not surprising for potential human subjects to have elements of fear factors and mistrust on the intended objectives of any clinical study (Johnson, Powell-Young, Torres, & Spruill, 2011). Hence, in setting up essential standard system that mitigates the inherent fear factor within clinical research environment for the betterment of public health system, scientists must be proactive to the clarion calls of respect, beneficence and justice depicted in the Belmont report of 1979.

Initiating a face to face, or in-person recruitment procedures may not always be feasible in a clinical trial recruitment process, but it is a more efficient and effective recruitment approach than many other alternative campaign incentives (Johnson, Powell-Young, Torres, & Spruill, 2011). An in-person recruitment methodology is very effective and important because, by nature, humans are very curious and inquisitive. Normally, in a situation of medical needs and quest for a better medical treatment, subjects will rely on physicians to make the best medical decision that fits the subject’s best interest.
In-person interactions between subjects and medical professionals may change some preconceived perception of a situation, and may encourage subjects to either participate or not to participate in a clinical trial. In addition, an in-person recruiting interaction is vital when potential subjects and medical research recruiters share the same or similar social culture or less ethnic barrier. According to a survey conducted by Johnson et. al on recruitment strategies; community based strategies whereby community leaders or representatives of ethnic or cultural origin within a community, actively advocates for a clinical trial enrollment, was found to have a significant and successful enrollment rate than an enrollment advocate from a divergent ethnic or social culture (Johnson, Powell-Young, Torres, & Spruill, 2011). Many conclusive data indicated that principal investigators or recruitment representatives of a particular ethnic group in a clinical trial has better enrollment turn-out, when targeting human subjects of similar ethnic or cultural background (Johnson, Powell-Young, Torres, & Spruill, 2011).

One of the reason for the racial-type bias approach is that subjects are more likely to trust someone that they think have their best interest at heart. In this case, cultural and ethnic similarities are strategic tools that remind clinical research scientists, the level of the racially charged stance stemming from historical racial and clinical research disparity. Racial-bias also remind scientists the scope of the racial divide in clinical research that are rooted in the past and perhaps, any present medical maleficent.

On the other hand, a population–based strategy is a strategy that deals with traditional post-card, mailing recruitment techniques, which has been in use for a long time. However, according to scientific surveys, phone recruitment strategy is significantly more successful in enrolling human subjects than the conventional mailing system at the rate of 63%-91% compared to the mailing method success rate of 3%-19% (Johnson, Powell-Young, Torres, & Spruill, 2011). Again, the survey is indicative of the effect of human interactions, psychological and behavioral pattern when personal interactions are subjected to one another.

The effect of supplemental strategy such as financial incentives in a clinical trial enrollment process is very important but, not on its own, very effective tool (Johnson, Powell-Young, Torres, & Spruill, 2011). There are other important concerns which negates the importance of monetary incentives. Some of these concerns are not limited to privacy, family belief and perception of scientific experiments involving human subjects (Johnson, Powell-Young, Torres, & Spruill, 2011). Hence, in fostering scientific innovation and healthy research growth, transparent disclosure of research rationale, active and positive educational programs, public health awareness and direct community service programs must be addressed and resolved in order to bridge this perception and ill-sense gap.

Other factors such as sample collection design may affect clinical research recruitment in a clinical trial. According to a survey, 91% of potential human subjects are more likely to participate in a clinical research involving saliva fluids sample collection versus 79% of potential subjects that are willing to participate in a trial that will require blood sampling (Johnson, Powell-Young, Torres, & Spruill, 2011).

Informed subjects tend to be information curious regarding the intended use of the samples collected during clinical trials. This type of tensed behavior or perception with sample collections during a clinical research trial stemmed from the experience of past historical scientific malpractices. Furthermore, assuring human subjects in a written statement or by any other means, of personal health information protection to avoid loss of personal information and staggering increment in health insurance premium after a clinical study, is one of the greatest challenge facing clinical research recruitment (Frank, 2004).

Principal investigators (PI) must set up recruitment strategies that cover diverse ethnic groups without compromising the validity of any clinical trial (Durant, Davis, St. George, et al. 2008). To avoid suspicion of maleficence in a clinical trial, PI must not over-crowd a clinical trial with one type of ethnic population if the trial is not categorically an ethnic group based study (Frank, 2004). Avoiding this type of recruitment strategy will not only sustain confidence within the public or subject participants, but it will also validate the intent of capturing genomic diversity effect in a clinical trial.

Thus, designing a better recruitment program in a clinical research requires the implementation of a community-based, population-based and a PI recruitment goal system in a clinical trial enrollment strategy. In addition, it is very important to use the supplemental strategies with caution and inclusively use educational programs, public health awareness and community service as a recruitment strategy. Perhaps, changing the ill-sense perception in clinical trials, also require scientists to maintain the integrity of good clinical practices/standards and adhere to the stipulated international and regional clinical research regulations.

References

Durant, R., Davis, R., St. George., D., et. al. (2008). Participation in Research studies: Factors Associated with failing to meet Minority Recruitment Goals. Ann Epidemiol, 17(8): 634– 642. doi: 10.1016/j.annepidem.2007.02.003. Retreive from http://www.ncbi.nlm.nih. gov/pmc/articles/PMC1976259/?tool=pubmed

Frank, G. (2004). Current challenges in clinical trial patient recruitment and enrollment, SoCRA Source, 30–38. Retrieved from http://www .socra.org/pdf/200402Current_Challenges_ Recruitment_Enrollment.pdf.

Johnson, V., Powell-Young, Y., Torres, E., & Spruill, I. (2011) A Systematic Review of Strategies that Increase the Recruitment and Retention of African American Adults in Genetic and Genomic Studies. ABNF J, 22(4): 84-9 Retrieved from http://web.ebscohost.com.ezp.waldenulibrary. org/ehost/detail?vid=3&hid=111&sid=6575 14f5-0abf-49fe- a7b2-5d14430ea139%40sessionmgr4&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d %3d#db=rzh&AN=2011363629.

National Institute of Health. (1993). NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research. Retrieved from http://grants.nih.gov/grants /funding / womenmin/guidelinesamended_10_2001.htm