Paper Example on Randomized Control Trial

Introduction

The randomized control trial is a scientific experiment that intends to minimise bias when testing a new type of treatment on patients. The experiment is usually controlled in terms of duration amount and the participants involved tend to be randomly selected and allocated to either the group that is to get treatment while under investigation or the group getting treatment as the control. Randomized control is used to test the effectiveness of various medical interventions and also help to provide detailed information concerning the adverse effects of the medications, for example, the drug reaction (Amar et al. p382). The randomization of the study helps reduce the selection bias while the varying comparison groups help the researcher to identify the effect of the introduced treatment compared with no treatment in the control group when other variables remain constant.

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The Key Components of the Design of Randomized Control Trials

Binding

The primary purpose of randomized control trials is to eliminate bias, the process of blinding the experiment participants or the participants and the investigator's assists in preventing the unconscious information bias. The blinding should be used in the used in the randomized control trials whenever possible. However, on some occasions, it is hard to bind the experiment investigators or the participants depending on the nature of the randomized control trial. Blinding also plays the role of minimising the contamination and non-compliance mainly in the control groups. Blinding is considered to occur in various areas that include, caregiving, in the collection of data outcomes, and adjudication of the outcome. In other cases, binding tends to be hard to maintain for instance during the treatment of the obvious side effects or benefits. In such a situation, it tends to be important to choose a tough or hard outcome, for example, death from any cause.

Randomization

Randomization tends to have various advantages that include first, eliminate bias in the treatment assignment, to enable Binding Of the of the treatment identity from participants, investigators, and assessors. The process of randomization should be unpredictable, tamper-proof and reproducible. The randomization scheme should be unpredictable so that it cannot be easy to predict which group would be subject to randomization. There are various types of randomization that include; block randomization is conducted within blocks four to eight subjects. The process ensures that there are a balance or control and treatment subjects in the experiment. Secondly, stratified blocked randomization whereby the strata are defined as per the essential subgroups or factors. For example disease severity and gender. The stratified block randomization ensures that a balance or equality in the treatments and the number of control subjects in each subgroup.

Interventions

The balance of the potential benefits and risks of intervention should effectively be assessed before the start of the experiment or research, everyone in the research may be exposed to the potential side effects of the intervention while it is not everyone who can gain the benefits of the intervention. Therefore caution, in this case, involves using the lowest of minimal effective dose. Considering that the randomised control trials are done under conditions have serious side effects may occur less frequently than the outcomes since the randomised control trials tend to be underpowered to identify the side effects. All the randomised control trials should have control groups, which help to assess the cumulative impacts of the other factors that may affect the outcome over time instead of the actual active treatment.

The Inclusion and Exclusion Criteria

The exclusion criteria tend to exclude the research subject which tends to mess up the study. The key reasons for excluding the studies include when the risk involved in the treatment is unacceptable if the patients are suffering from other conditions that may interfere with the general interventions and when the research patient is not likely to finish the follow-up or keep up with the set procedures. `However one should refrain from employing excessive exclusion during the research even in the situations when they appear so rational. On the other hand, the inclusion criteria are used to optimise various things that include, expected treatment efficacy, the recruitment, monitoring and patient compliance and checking the generalizability of the outcome results. Therefore, in the inclusion criteria, the main aim is to note the subpopulation in which the intervention will give the desired effect or outcome.

Challenges of Randomised Control Trials

Despite the randomised control trials has made significant development in the recent past, the RCTs are still facing some crucial challenges that need to be addressed for the study to maintain their credibility and acceptability. This challenge includes, first, challenges in making an impact evaluation to look more like evaluation and less like the research study. Many impact evaluations are considered to put their focus on the research question that is of interest to the author while ignoring the evaluation question that is of interest to the policy maker (Stubbs et al. p250). This challenge tends to affect the choice of measures to be evaluated the evaluation design to be used and the method of reporting the findings. The main focus of this research should focus on assessing the real-life programs instead of the interventions created by the researcher.

Secondly, ethical issues of the randomized control trials. Currently, there has been a tremendous increase in data collection in developing nations. These surveys tend to be time-consuming mainly for their respondents involved. Therefore we should believe that what is being done is worth not just for us as the researcher but also for the poor people whose time is consumed while conducting the studies. The issue of time consideration tends not to be an issue of concern to main researchers, but in the real sense, it should be an issue of concern to the researchers conducting the studies.

Do the Randomised Control Trials Apply in Contemporary or Alternative Therapies?

Contemporary therapy refers to the therapy that tends to complement the b traditional western medicine and tend to be used together with conventional medicine. While alternative medicine or therapy refers to the therapeutic approaches that are taken instead of traditional medicine with the intention of treating ameliorate diseases. Randomised control trials do not apply to both the contemporary and alternative therapy, and this is because both treatment therapies are considered to lack solid research on which an individual can base sound decisions (Egnew & Thomas p171). The possible benefits and dangers of both contemporary and alternative therapies have remained unproven. On the other hand, conventional medicines or therapies are the ones considered to rely on t5he methods that are proved to be effective and safe with the well-designed research trials.

Works Cited

Amar Bhide1 , Prakesh S. Shah2,3 & Ganesh Acharya. A simplified guide to randomised controlled trials (2018)

Egnew, Thomas R. "Suffering, meaning, and healing: challenges of contemporary medicine." The Annals of Family Medicine 7.2 (2009): 170-175.

Stubbs, Brendon, et al. "Exercise improves cardiorespiratory fitness in people with depression: a meta-analysis of randomized control trials." Journal of affective disorders 190 (2016): 249-253.