Clinical Research and Trials - Assignment Example

ETHICAL SELECTION OF RESEARCH S SELECTION OF WHITE MALES AS RESEARCH S Clinical research and trials are gaining importance by the day, with astounding improvements that medicine is bringing about. Medication and treatment is on a steady rise towards perfection and these research sessions contribute to the authenticated administering of medication. In many clinical trials, the majority of research subjects enrolled are white males. However, this is not representative of the entire U.S. population, which is comprised of other ethnic groups, like the 'African American' and the other minorities. Therefore, the million dollar question is, is the primary enrolment of white males into clinical trials consistent with the ideal of a fair and equitable selection process that ensures a fair distribution of the burdens as well as the benefits of research This article on the unequal representation of the entire component of the U.S. population, is to convey the opinion that such disproportional representation is not fair and does not make the most of the diversity available, while bordering on racist inclinations and gender inequality, as well. It also attempts to put forth a convincing argument, with evidences, to uphold the fact that inclusion of the blacks, as well as, the female population would certainly lead to a better prospect for the industry, since to throws up lurking talent, while also paving way for a more balanced research. This not only wipes out grievances that exist in the non-represented part of the population, but also promotes equality and brotherhood. Clinical research is a particularly difficult topic. In most research communities industrial and federal agencies have been, for more than a decade, refusing to obtain information about inconsistent drug effects on patients based on race, ethnicity, gender and age. I will discuss the model development, study design in relate to clinical trials. Also I will talk about the participant factors in general and my personal factors. The last point I will be discussing is the ethnically diverse patients. ANALYSIS SELECTION OF SUBJECTS The ideal path towards success for any industry, is to make the most out of the man power and talent pool available. Under such circumstances, the selection of candidates is a crucial phase. Priority attached to a particular strata or section of the society, while leaving out the others, is often dangerous as it paves way for inequality and further, it does not recognise the talent of the rest of the masses. Our core industry and area in this article, is that of the U.S. clinical research, wherein majority of the individuals enrolled for the research are white males. The very mention of 'white males' highlights the fact that two important sections of the society---the females and the blacks are not very prominently represented in the enrolment. In the Model Development the proposed Model for Clinical Trial Participation was developed based on a literature review and experiences with subject participation. Analysis and use of the model in implementation of clinical trials may be helpful in all research disciplines. The model identifies barriers and issues related to clinical trial participation, strategies that can be used for success, and outcomes for successful clinical trials. A literature review indicated that successful clinical trials depend on certain key issues and factors: study design, participant factors, issues related to ethnic diversity, the informed consent process, and physician factors. Strategies for success are identified in the model to overcome these issues and concerns, and specific outcomes are identified. Healthcare providers across disciplines can use the model prior to and during enrolment of patients into studies. A literature review revealed specific barriers and factors related to the success of clinical trials. The major barriers identified were study design, participant factors (i.e., general and personal issues related to special populations), the informed consent process, and physician factors. DISCRIMINATION AMONG SUBJECTS-GENDER AND RACE It is proven time and again, through the revelation of statistics and other studies conducted, that the females are equally and even more talented than their male counterparts, when it comes to education and academics. In fact, statistics reveal that the females are on par with their male counterparts, when it comes to higher education and talent utilization. (Website: http://nces.ed.gov/pubs/96768.pdf.) Therefore, it is certainly obvious that the clinical research sessions enrolling white males, primarily, are missing out of some extra-ordinary talent that can transform the industry to a large extent. The other important aspect that the statement reveals is the bordering of racism that is clearly evident in the enrolment of white males, over the blacks. This can be quite hazardous to a service industry like medicine, to which clinical research is quite jointly associated. This field operates on certain ethical principles like justice, equality and vindication. Therefore, the lack of equality in the enrolment process itself, is quite disheartening. This again causes the industry to lose out on some great potential talent that could be hidden in the section not represented. IS IT ETHICAL Such discriminative practices in the enrolment processes are not only harmful for the ideals of promoting equality and brotherhood in the society, but are also very destructive to the concept of welfare. Welfare in the society can be brought about only by equal representation and administering of grievances; and by adequate opportunities provided to all and sundry. This disproportionate representation prohibits them from accruing the benefits of the research. It not only poses a loss for the industry, but also disallows the opportunity for individuals from all strata and sections, to take up the burden and serve the industry. Therefore, it evidently is a two-way sword, and quite a disadvantageous one for not one, but both sides. Finally, ethnically diverse patients are another very critical issue is increasing the number of ethnically diverse patients involved in clinical trials. Typical clinical trial participants are white, have higher levels of education, are in the middle-to-upper socioeconomic class, and are male. Increased participation by women from diverse groups is an important goal. Identified barriers to minority participation are historical; economic; social and cultural issues; availability, affordability, accessibility, and acceptability of clinical trials for minorities (McCabe, Varricchio, & Padberg, 1994; Thomas, Pinto, Roach, & Vaughn, 1994); and research (Swanson & Ward, 1995). CONCLUSION Although African Americans have the highest age-adjusted incidence of cancer and mortality rates in the United States, they remain underrepresented in prevention and control studies (Paskett, DeGraffinreid, Tatum, & Margitic, 1996). Historical incidents perpetuate mistrust and fear among African Americans related to clinical research. This mistrust is not only a product of the patient population, but also of African American physicians who often fail to refer patients for clinical trials (McCaskil-Stevens et al., 1999). In a study of perceptions of African American women about participation in clinical trials, 29% felt that researchers did not care about them compared to 14% of white women surveyed. Only 28% of the African American women felt that the research was ethical (Mouton, Harris, Rovi, Solorzano, & Johnson, 1997). REFERENCES Website: http://nces.ed.gov/pubs/96768.pdf McCabe, Varricchio, & Padberg, 1994; Thomas, Pinto, Roach, & Vaughn, 1994 McCaskil-Stevens et al., 1999 Mouton, Harris, Rovi, Solorzano, & Johnson, 1997 Read More