Hello, this is Sam from Ref-n-write. In this video, I will explain how to write a clinical trial research paper. We will go through the basic components that make up a good clinical paper. The title of our research paper is ‘The Effects of Vitamin D Supplements on Obesity: A Randomized Clinical Trial Study’. I must insist that this is not an actual research paper. This is just an example research paper we put together for the purposes of teaching. Before we move on to the video, if you still haven’t installed Ref-n-write software, please do it now. It comes with Referencing tools, Paraphrasing Tools and Academic phrasebank And a lot of other useful features to help you write your research papers and theses. You can sign up for free Using the link below in the description. Now let's get back to the paper. Let's start with the introduction paragraph. This is the place where you tell you readers what is your topic and why it is important? It is a good idea to start your intro paragraph with a hook A hook is a powerful opening statement designed to grab the reader’s attention. This can be a fact, a statistic or a question. Since our study is about obesity, let’s give an interesting statistic about obesity. After starting with a broad statement, the next step is to narrow down the topic. Here, we are dropping a hint that our paper is to do with vitamin D and obesity. With the next statement we are establishing the importance of the topic. and vitamin D is causing a lot of health issues, so we must do something about it. We are saying that a lot of people are dying due to obesity, Then in the final statement of the intro paragraph, we explain how conducting research in this field will benefit the community. In our case, doctors will be able to prescribe better treatment options for obese patients. That concludes the introduction paragraph of our research paper. Let's move on to literature review. This is where you provide a comprehensive summary of previous research on this topic. Let’s start with a broad statement summarizing the research in the area. Here we are saying that many studies have confirmed some sort of link between vitamin D and obesity. Now let's move on to specific studies. Here we are reporting the results of a specific study that came out recently that talks about the link between vitamin D and obesity in western countries. Now let’s talk about some mixed evidence that casts some doubt on the current understanding of the topic. We are saying that some studies have shown that obesity causes vitamin D deficiency, whereas other studies have shown that it is in fact vitamin D causes obesity issues among people. Now it's time to establish the research gap. The previous statements we made nicely lead on to this statement. We are saying that we are lacking clear evidence linking vitamin D to obesity. We are also saying that most of the existing studies were conducted on subjects with preexisting health conditions, so there is a research gap to be filled. Now you must define your research question and explain how it addresses the research gap you established in the literature review. We're saying here that the main aim of this study is to investigate the effect of vitamin D on weight loss among healthy population. We are also defining a specific hypothesis that we will either prove or disprove towards the end of the paper. Let's move on to materials and methods. The materials and methods is one of the most important parts of your paper. This section should have enough detail so that another researcher can reproduce your experiments and results. Let's start with study design. In clinical trial papers, you must explain about the study design you have employed in your work. In our case, it was a randomized double-blinded placebo trial. Then you can talk about the location and period in which the clinical trial was conducted. Then provide details about the ethical approval that was obtained for the study. Nowadays it is mandatory to register your clinical trial on the website, clinicaltrial.org before you start recruiting patients for your study. You must also include the registration number. I must warn you that many journals will refuse to publish the results of your paper if the clinical trial is unregistered. Good clinical practice (GCP) is a set of internationally recognized quality standards that must be followed when conducting clinical trials involving people. It is a good idea to provide information about who is responsible for monitoring this for your trial. It is very important to define the inclusion and exclusion criteria used for the study. The inclusion criteria define the characteristics that will make subjects eligible for the study. In our case, we only included non smoking and non diabetic subjects with BMI greater than 25. In our case, we are excluding subjects participating in weight loss programs and taking dietary supplements. In our case, we recruited 50 subjects in the age range 15-60. Let’s provide some information about the recruitment procedure. In our case, there was a face to face interview to confirm eligibility. And also, the eligible participants were asked to fill in a questionnaire so that we can gather demographic information. Another important part of recruitment process is to get informed consent from the participants. The participants should be given all the information about the trial including the benefits and risks, so that they can make an informed decision as to whether to participate in the trial or not. Let’s explain how the participants were grouped into different groups. In our study the participants were randomly split to into intervention and control groups, and the control group was given a placebo. Our study is double blinded, it means neither the participants nor the researchers knew which group they belong to. Let's talk about the follow up period. It is very important to choose a good follow up period for your study. Because a shorter follow up period will result in an underestimation of the effects you are measuring. Whereas with a long follow up period, there is a risk of subjects dropping out of the study. In our case we have chosen a follow up period of 12 months, and the measurements were performed every 6 months. Then we have to explain what parameters we are measuring on the participants during the course of the study. In our case, we measured BMI, waist circumference and blood pressure. BMI is the primary outcome. It means it is the most important outcome and we will analyze the changes in BMI values to either prove or disprove our hypothesis. The secondary outcomes such as waist circumference and BP are additional measurements that we perform to provide supporting evidence for the main finding. Let’s talk about the statistical analysis and statistical tools used for the study. In our case, we are using an independent sample t-test for statistical analysis. The independent sample t-test compares the means of two groups, in our case, vitamin D group and placebo group. We also specify the definition of statistical significance. if p value is less than 0.05 then we will consider the difference to be statistically significant. We also give the format of the data presented in the paper. in our case, all the data will be represented in the format, plus or minus standard error. Let’s move on the results section. This is where you present the core findings of your study. You have to present your results in a logical sequence. Do not interpret the results here. Save them for the discussion section later. Before jumping into results, you have to first let the audience know if you did any preprocessing or data clean up before the analysis. In our case, 4 participants had to be excluded from the study due to health issues. And two participants dropped out due to personal reasons. So it means that we are dealing with a slightly small sample size than we initially set out. Try to present your data in figures and tables, and only elaborate the most important results in the main text. In our case, we are presenting the characteristics of both groups in a table. And we are plotting the change in BMI over time as a graph and presenting it as a figure in the paper. Now let's start with the main finding. In our case, we found a significant drop in the BMI among the cohort taking vitamin D supplements. Since we use the word significant, we have to provide a p-value. Let's move on to the next result. we are reporting that there is no significant difference in blood pressure between two groups. We are also providing actual values in the text. We've already mentioned in methods section that the data will be in the format mean plus or minus standard error. Let's move on to discussion. This is where you interpret your findings and compare your results with previously published work in this domain. This is the place to talk about limitations and future direction of your work. It is a good idea to start with the main result. In our case, we found that vitamin D reduces the BMI supporting the main hypothesis. Let’s also mention how these findings fits into existing research in the domain. In our case, these findings are in line with results of previous studies published on this topic. Now let's move on to a negative result. In our case, we observed a negative association between waist circumference and vitamin D. Now give your interpretation of this negative result. We think it is because of he shorter duration of the study. Let's report an unexpected result. In our case, we found that the blood pressure was bit on the higher side with the cohort taking vitamin D supplements. Let’s give our interpretation of the result. We believe it is because of limited data. Let’s talk about the implications of our research. This is where you describe the significance of your findings. You can also explain how your findings contribute to the existing body of knowledge and impact future research in the area. Then add one or two lines about the novelty of your research. Explain what is so unique about your research? In our case, this is the first study to be conducted on a healthy population. Let's move on to limitations. Every study has limitations. If your hide your limitations, I can guarantee you that reviewers will reject your paper. Be honest about the limitations, and explain how future studies can rectify the shortcomings of your work. In our case, the major limitation is that our study uses a small number of participants. Let's move on to the final statement of the paper. Finish your paper with one or two lines about the possible future direction of your research. In our case, we can conduct a much bigger study to reconfirm our findings in the future. I hope you found this presentation useful. If you have any questions, please drop a message below. We will answer it as soon as possible. If you like this video and would like to learn more about writing research papers or thesis you can sign up for our training courses using the link in the description below. Finally, please subscribe to our channel to get future updates.