Inferential Statistics (m4c) - Essay Example

It is claimed that a new drug is developed which provides the same level of efficacy as the currently used cocktail of multiple drugs in treating AIDS. Problem is to set up an experiment and select subjects to test the efficacy of the new antiretroviral drug. Antiretroviral drug treatment guidelines have changed over time and there is no unique guideline for all countries. Treatment regimen prescribed is also different for different groups of patients. For example, drugs prescribed for pregnant women in a developing country may be different from drugs prescribed to adults and adolescents in a developed country (World Health Organization Guidelines).

Therefore, identification of the population among whom the new and the current combination of drugs are to be compared is necessary. Let the population thus selected be the adult and adolescent population in the United States. There are literature considering differential effectiveness of highly active antiretroviral therapy among patients of different gender and race. (King et al., 2008; Campo, Alvarez, Santos, & Latorre, 2005). However, part of the difference may be attributed to availability of the drug, following the prescribed regimen and lifestyle, rather than any inherent difference in genetic composition.

Nevertheless, it will be a good policy at the initial stage to limit the experiment among adult and adolescent Caucasian males to protect against possible confounding effects. Once the population is identified, a sample of specific size needs to be selected. The sample size will depend on the power of the testing procedure, which is outside of the purview of the present consideration. Current guidelines recommend start of antiretroviral therapy when the disease has progressed to WHO Stage III when CD4 cell count is less than 350/μl.

This may be taken to be the baseline criterion for inclusion. Also, the standard guidelines for adherence to the protocol, testing for baseline resistance etc must be satisfied to be included in the drug testing. It is of singular importance to compare the new drug against one specific drug combination. The preferred regimens may be any one of the followingemtricitabine, tenofovir and efavirenzemtricitabine, tenofovir and raltegraviremtricitabine, tenofovir, ritonavir and darunavirmtricitabine, tenofovir, ritonavir and atazanavirAny one of these regimens needs to be chosen for the new drug to be compared against.

Ideally this experiment would be a matched case-control study. Two HIV/AIDS patients with very similar profiles with respect to advancement of disease, CD4 cell counts, age, sexual orientation and other possible factors that may have bearings on the disease are to be randomly assigned either to the cocktail drug regimen or to the new drug regimen. However, there may be ethical consideration to such assignment. Without informed consent of the patients they may not be assigned to a new drug therapy.

As antiretroviral therapy is to be continued life long, it is difficult to arrive at a definite conclusion regarding efficacy of the new drug within a definite period of time. One way to deal with that is to compare count of CD4 cell counts for patients under existing and new drugs from time to time and monitor the disease’s progress or retardation. Naturally, count of CD4 cells is the dependent variable, which depends on the effectiveness of the drug. It needs to be noted that the new drug may be more efficacious at the beginning of the regimen and may, in the long run, be bioequivalent to the existing regimen.

Alternatively, the effect of the existing regimen may taper off at some point where the new drug may continue to be active. Therefore, the experiment may have multiple end-points and one or more end-points must be clearly noted in the protocol.ReferencesWorld Health Organization (2011). HIV/AIDS Guidelines. Accessed on Jan 27, 2011. .King, W. D., Minor, P., Kitchen, C. R., Ore, L. E., Shoptaw, S., Victorianne, G. D., & Rust, G. (2008). Racial, gender and geographic disparities of antiretroviral treatment among US Medicaid enrolees in 1998.

Journal of Epidemiology of Community Health, 62, 798-803.Campo, R. E., Alvarez, D., Santos, G., & Latorre, J. (2005). Antiretroviral treatment considerations in Latino patients. AIDS Patient Care and STDs, 19(6), 366-374.