Research Design And Methodology For Company XYZ Vaccine Testing

Literature Review

Discuss about the Research Design for Beyond Nature Writing.

The landing of an alien object about 12 months ago on earth possess a great threat to human population. The objective carried with it a new virus that has wiped out millions of humans according to researchers. Projections are that human population will be wiped out within the next 12 months due to skyrocketed rate of death resulting from new virus. For this reason, Company XYZ has developed a vaccine to counteract the virus. Successful preliminary clinical tests on animals have been undertaken by the Company. Unfortunately lack of adequate time has impeded the testing of this vaccine on humans. Company XYZ remains stranded on what particular population it can test the vaccine within the shortest time possible, and yet cover a large human subjects prior to the distribution of the vaccine to the entire world’s population. It is upon this dilemmatic situation that Company XYZ has called for the proposal bids to help locate the best human population to undertake the test save the looming human extinction. The underlying research question of this study will be “What is the best large population that will respond faster to the testing and enable Company XYZ to test the vaccine within the shortest time possible to save the looming human extinction from the wrath of a new virus that resulted from the alien object?”

Literature Review

Testing a vaccine with human population is a critical issue that needs a lot of confidence. Vaccine development and testing follow standard set of steps in many countries. For example in the United States, a researcher would not just wake up one day and decide to test a vaccine on human population without following the laid down procedure. The initial stages are exploratory in nature. The literature show that regulation and oversight heightens as the candidate vaccine makes its way via the process. As revealed in XYZ Company, this exploratory stage has been executed successfully since they have reached a point of undertaking test with the human subjects. This means that Company XYZ has passed both exploratory and pre-clinical stages. The next step in determining the best population will involve IND application. In this case Company XYZ will be required to submit an application for an investigational New Drug (IND) to the Food and Drug Administration.

The Company XYZ will have to give a comprehensive description of manufacturing as well as testing processes of the vaccine. It will also present a summary of the laboratory reports alongside a detailed description of proposed study (Creswell 2013). The institutional review board which represents an institution in which the clinical trial will be executed will have to approve the clinical protocol. The FDA will have a maximum of thirty days to give approval of the presented application. Upon the approval of IND, the vaccine testing is subjects to three stages of testing. The clinical studies with human subjects will follow based on phase one (vaccine trial), phase II (vaccine trials) and phase III (vaccine trials).

Research Question

In phase I, involves an assessment of candidate vaccine in human encompass small group of adults normally between 20 and 80 subjects. Phase one testing aims at assessing the safety of the candidate vaccine as well as determining the type of alongside extent of immune response provoked by the vaccine. In phase II, a large cohort of hundred people taking part in phasing testing. In this phase certain individuals can belong to cohorts at risk of acquiring the underlying disease. Phase II trials are randomized as well as controlled and entails placebo. The primary goal of Phase II testing is to study the candidate vaccine’s immunogenicity and safety. It also help determine the vaccine’s proposed doses, method of delivery as well as immunization schedule.

The last stage of vaccine testing is phase II vaccine trials which succeeds successful phase II. In this phase, candidates shift to larger trials. It involves thousands to tens of thousands of individuals of people. The test are randomized as well as double blind. It is at this phase where vaccine testing becomes experimental against a placebo which can either be a saline solution or vaccine for another disease.

Phase III aims at assessing vaccine safety in a large population of people. This is because particular rare side effect my fail to manifest in small cohorts tested in stage one and two. It involves both treated and control group and test the efficacy of vaccine as well. It determines whether the candidate vaccine prevents disease and whether it prevents infection with the pathogen. Phase III also determines whether the candidate vaccine leads to production of antibodies alongside additional types of immune responses linked to pathogen.         

Research question

What is the best large population that will respond faster to the testing and enable Company XYZ to test the vaccine within the shortest time possible to save the looming human extinction from the wrath of a new virus that resulted from the alien object?”

Research objectives

To determine the best large population that will respond quickly to vaccine testing to allow Company XYZ to test the candidate vaccine within the shortest time possible to save the impending human extinction from the new virus that accompanied the alien object.

Research program

It will be a quantitative, comparative, controlled experiments where the investigator will study two intervention services of subjects who receive them in random manner. The RCT is chosen for this study since it is one of the simplest as well as most powerful technique in clinical research. It will also use a placebo and double blind method to ensure that neither the participant nor the investor know those in the test or control group for easily comparison of the efficacy of the vaccine.   

Research Objectives

Research design and methodology

The determination of the most appropriate research design is a critical issue that has to consider effectively many factors linked to a particular study. The investigator has to take into account the research hypothesis, questions as well as whether the variables will be utilized. Most importantly, the difficulty of choosing the particular design is surpassed by the study characteristics. In this research, it is appropriate for Company XYZ to use exploratory quantitative research to determine the best population that will help test this vaccine faster. This is effective and in line with the research program which uses a randomized control trials which produce outcomes which are measured. The study will use a randomized trial to recruit the subjects for undertaking this text.

An experimental research design will be used to undertake the testing whereby there will both control and treated group who will receive the intervention. The experiment will involve the use of randomized trial and double blind where the testing of the candidate vaccine will be tested against a placebo which will be either a vaccine for another disease or a saline solution. The experimental design will help test the efficacy of the candidate vaccine. Particularly, the testing will stress whether the candidate vaccine prevent disease, whether the infection with the pathogen as well as whether the candidate vaccine lead to the production of antibodies alongside other types of immune response connected to the pathogen. The test will also focus on testing the existence of adverse event linked to the candidate vaccine.

The detection of the adverse event will be based on assessing the significant difference for a low-frequency event. This will be achieved through having a large population of subjects with half being in the control or no vaccine cohort. The double blind will be effective in this experiment since neither the subjects nor the experimenters know the participants in the test or control groups during the actual experiment course. Experimental design is the most exemplary models of research or original design in this vaccine testing case.

The experimental design is effective as it permits the investigator to control both exogenous variables while eliminating the extraneous variables as compared to other research designs. Moreover, this research design allows for the determination of causal relationships as it involves the manipulation of exposure to exogenous variables. Therefore, the researchers are presented with a promising opportunity to observe cause and effect as well as the influence of exogenous variable on the endogenous variable.  It is not easy for the experimental design to do away with or control extraneous variables as this becomes increasingly impossible.

Research Program

Sample unit and sampling methodology

The sampling methodology or technique for recruiting the subjects will be randomized trial control. The vaccine testing will have both control and test group in equal numbers. The recruitment will be preceded by a consent given by the participants to take part in the study. Subjects allocation will allocated in either control or test group at random once they have given a consent to participate in the vaccine testing. RCT will be recruit subjects who will receive one of several clinical interventions. The control will be a placebo-based to help measure and compare the outcomes after the subjects receive the intervention to determine the efficacy of the candidate vaccine. RCT will be quantitative in nature since these outcomes are measured.

The random technique will, therefore, help recruit the best population for testing the candidate vaccine. The participants will be assured of confidentiality of the information and the health records by ensuring that pseudonyms are used. In addition, they will be told about the intended use of the information collected from them as well as how it will be stored. Moreover, the researcher will also ask for permission from the authorities of hospitals from where the subjects will be recruited. In case the information collected would not be used for the intended purpose, consent will be sought out again from the participants.  The participants will also be assured that they are free to leave the study at will irrespective of the time or phase of the experiments. 

Data Collection

Data collection will be based on the outcomes of the test or interventions that will be administered to the treated or test group based on the comparison between the control and test group. The questions that will guide the data collection will be: (i) does the vaccine lead to generation of antibodies or other types of immune responses to associated with pathogen (ii) does the vaccine prevent the infection with the pathogen? (iii) Does the candidate vaccine prevent disease? Together, these questions will help collect the data on efficacy of the vaccine.

Others questions will include whether the vaccine is safe in a large group of people as well as whether the candidate vaccine will have certain rare side effects. Other questions will relate to the adverse events occurring after the administration of the candidate vaccine to the test group. Other data to be collected will include the immunogenicity, proposed doses, immunization schedule as well as method of delivering the vaccine. Data will also collected on the type and extent of immune responses that the candidate vaccine will provoke.  

Research Design and Methodology

Data Analysis

The analysis of data will be thematic in nature to determine the effectiveness of the vaccine in treating the new virus. It will focus on efficacy of the candidate disease particularly its ability to prevent the disease, its ability to prevent the generate antibodies and its ability to prevent the pathogen infection. The immunogenicity and safety of vaccine will also be analyzed to present the effectiveness of the vaccine. Side effects and adverse events will also be analyzed. The thematic analysis will help make a deduction on whether the population chosen was the best one to test the vaccine.    

Validity and Reliability

The researcher will guarantee the trustworthiness via stressing the validity and credibility of the study. For example, I will strictly try to ensure internal validity. It should be noted that ensuring credibility is an essential factor in establishing trustworthiness. I will adopt the research methods well established by using methods that have used successfully used in previous vaccine testing projects. I will also use such criterion as transferability, conformability as well as dependability to ensure trustworthiness that then accounts for evidence of quality.

I will ensure a prolonged engagement in the field so as to immerse myself in participants’ world. This will greatly help me to have effective insight into the context of the research to limit the distortion of the information. I will also allow for member checks to improve the quality of my quantitative study hence increased credibility (Caputo & Scanlon 2007). The limitation of this research will be to deal with a large group to undertake effective vaccine testing. Getting this best population will be the most challenging task of this study.

Summary Statement

The experimental research design will help address the issue of choosing the population to undertake the vaccine test that Company ZYZ in exploring and will provide the answers to their questions. The randomized Control trial, placebo and double blind will ensure effective recruitment of the subjects. Since the randomized control trial is quantitative in nature, it aligns to quantitative methodology chosen for this study to find the best population (Armbruster 2003). By answering all the question mentioned in the data collection method section, a characteristic of the required population will be revealed and this will help locate the best population to undertake the vaccine test.

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