Randomized Clinical Trials(Randomized Clinical Trials

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Randomized Clinical Trials(Randomized Clinical Trials

Randomized clinical trials (RCTs) are known to be one of the most reliable types of research. To avoid selection bias, an experimental group as well as a control group is chosen at random using effective established methods. The two groups are alike in every way possible. The experimental group receives medications, procedures, or other interventions while the control group does not. Known as blinding, neither the groups nor the clinicians studying the groups know who is participating in which group. The two groups are then followed over a specified timeframe and the differences, if any, in outcomes are measured. As with any type of study, flaws can exist. With RCT, as an example, participants might drop out for various reasons, negatively affecting the makeup of a group.

If it is discovered that the experimental group is experiencing extraordinarily positive results during research, there are mechanisms in place, such as fast track, breakthrough therapy, accelerated approval, and priority review procedures. Normally, the Food and Drug Administration (FDA) can take years to approve a particular drug or treatment. As an example, if an experimental group is receiving medications to slow down multiplication of the AIDS virus and studies were showing remarkable decreases in the amount of virus present after one month, the control group then might be allowed to receive the medication after FDA approval. This seems to be the only ethical thing to do, but there was a time when fast track and other methods did not exist.

It is important to note that when human subjects are used in research, specific guidelines must be met to ensure the safety of the subjects. The clinical institution or manufacturer must establish a contract with an institutional review board (IRB). The IRB provides approval and oversight of research to ensure that laws, informed consent, safety procedures, and expected ethical standards are followed. Anyone planning to conduct research on human subjects must go through the IRB process prior to beginning research. The IRB can modify and even disapprove applications. They can also suspend research if they discover the guidelines are not being followed.

Mechanisms in Clinical Trials

As per the US Department of Health and Human Services (2018):

Under certain circumstances, the Food and Drug Administration (FDA) will prioritize or approve medications that have demonstrated potential to provide significant improvement in those experiencing undesired effects of certain medical conditions. Below you will find a chart depicting some of the processes in place to speed the approval of some medications.)

Before beginning work on this assignment, please review the expanded grading rubric for specific instructions relating to content and formatting.

So far in the course, we have learned that healthcare leaders and managers must seek out credible information and data when decisions are to be made and when educating others. It is vital that they review at least three, preferably more, sources to determine credibility of information. In order to know they are using credible data, it is important for them to have a solid understanding of how data and information are collected and compiled. Knowing what processes and procedures should take place to produce credible data is important. Familiarity with the scientific method is a must.

All studies are subject to bias, some more than others. Even with potential bias, research is critical to literally everything we know and do in the healthcare services field. Knowing research is not perfect, leaders and managers can still use data effectively.

There are many types of bias that can affect research outcomes. For your project this week, thoroughly research and discuss the following types of bias that can affect the credibility of resources. Please give specific examples of how these types of bias can alter results of studies.

Sampling bias
Selection bias
Interviewer bias
Response bias
Observation bias
Leading questions and wording bias
Sponsor bias

cite your sources in your work and provide references for the citations in APA format.