A well-designed study will clearly identify an exposure/risk and an outcome in an objective, quantifiable manner to answer a defined hypothesis/research question.
A well-designed study will clearly identify an exposure/risk and an outcome in an objective, quantifiable manner to answer a defined hypothesis/research question.What barriers or challenges have you encountered?How did you handle them?Did you need to change/revise your project design?
I have learned throughout our clinical research courses with ASU that the trial study must be well designed to ensure there are no potential risk and exposure that will affect the safety of trial participants. To ensure there are ethical considerations for trial participants, the leading investigator of the trial, its sponsor and the clinical staff must ensure that people involved in the trial have provided their consent to participate in the trial. The study processes must be made transparent to the trial participants, and the investigator must ensure that good clinical practices is a continued practice throughout the trial process. (A Critical Evaluation).
The study design and protocol are very important to the overall success of the clinical trial. As noted by the National Library of Medicine in an online article or journal , “defining the objectives for research is essential to the important considerations in the development of a research question. The primary research question should be driven by the hypothesis rather than the data., That is, the research question and hypothesis should be developed before the start of the study. The research or clinical hypothesis is developed from the research question and then the main elements of the study, sampling strategy, intervention (if applicable), comparison and outcome variables are summarized in a form that establishes the basis for testing, statistical and ultimately clinical significance.” (ncbi.nlm.nih.gov).
In designing a clinical research study, there are always barriers that may be encountered, and challenges faced to ensure continued safety and efficacy for trial participants. The research question is very important to determining what the study design will be, and what is the purpose of the study, and determining an expected outcome and hope for achieving in the study results. In my opinion, a barrier that may be encountered will be to determine if the trial will be experimental or observational. The study design may be formed to address a new drug or medical device being observed in how it affects, or solve a particular medical question, disease or health concern. In addition, the challenges with testing new drugs and medical devices on trial participants can be risky or provide a different or unexpecting outcome as determined in the initial study design.
In looking at these research parameters, evaluating my capstone requires discovering the ethical considerations or non-ethical practices of trials that went horribly wrong and failed its participants. The case studies of failed trials are a challenge in which there is a need of continued evaluation to acknowledge how barriers and encounters were handled.
In observation of the case studies in my capstone, some of the randomized trials I have encountered, presented challenges where safety considerations among researchers were not upheld. I had to determine what was identifiable as a good trial and, analyzed how the different outcomes of each trial case study followed a pattern of unethical trial processes. Some of the treatments of new drugs given to participants in the trials caused serious adverse events. Whereas there was a correlation of factors and questions of safety practices that showed comparable amounts of control, and lack of informed consents from trial participants. For example, the case where prisoners were exploited, and had no control in giving of consent; they were ordered to participate in an unethical and unsafe research experiment. Another analogy presents, “blind random trials which reduce the likelihood that behaviors of subjects or investigators could influence the results of the study. In a single-blinded study, subjects are unaware of their treatment status, whereas in a double-blinded study both the investigators and the subjects are unaware of which intervention the subjects receive.” (A Critical Evaluation).
Through my research, and capstone project, I have uncovered so many barriers. The barriers such as with unethical practices which determine there were exposure to new drugs, and outcomes where the study participants were subject to unethical treatments, deformities, and many encountered deaths. A barrier or unanswered research question of efficacy and safety showed there were participants who encountered debilitating illnesses they didn’t have before participating in the clinical trial. The way I handled these barriers were also to go back to the beginning stages and look at the regulations, and to observe the Belmont Reports principles and determine if the trial showed these beneficial factors. In addition, it is my thoughts, that there are advantages and disadvantages to how a trial design is effective and is designed to ensure “respect of persons, beneficence, and justice” as noted in the principles of the Belmont Report. (The Belmont Report).
Moreover, to efficiently handle the barriers and challenges with designing a clinical trial is to determine the risks associated with trials, how trials can fail, and to look at the ethical processes of a well-designed study. In answering a hypothesis or research question, I find that the need to design and redesign a trial study is very significant to following the trial protocol and taking great safety measures.
Therefore, the advantages are to ensure the trial has an effective outcome where safety and efficacy has been the premise throughout the course of the trial. On the other hand, the disadvantages of a trial which is not well-designed shows the lack of trial safety for its participants. Furthermore, the challenge of a participant being exposed to a harmful trial can affect the success of a study, its design, and outcome. The risk factors will be higher promoting greater barriers and challenges to work through, whereas if it were my trial, or as in my capstone, the process is to uncover what exposure and risk can lead to a failed trial. Nonetheless, as needed before the final submission, I will be changing and redesigning my capstone’s project design, and to ensure it shows both the advantages and disadvantages of clinical trial outcomes.
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https://www.jidonline.org/article/S0022-202X(15)36682-3/fulltext (Links to an external site.)
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For my capstone project, I developed a questionnaire that was administered to CRCs. Ideally, I would have preferred to conduct focus groups with participants, however, this type of method would have been significantly more complicated and not feasible to complete in ten weeks. Yet, developing questionnaires is challenging because the questions should be unambiguous, not misleading, and appropriate for the study population (Jacobs 1974). Questionnaires should also be reliable and valid. There are several different types of questions that make up a questionnaire including multiple-choice questions, open-ended questions, and two-way questions, each with its own problems. Although open-ended questions would provide higher quality responses, the responses would also have to be grouped together or coded into “themes” which is also a complicated and lengthy process. Therefore, for my capstone project, I choose to develop a questionnaire that was primarily made up of multiple-choice questions.
Due to the short time, I did not change or revise my project design. One of the limitations of my study is the number of influence questions that I included in the questionnaire. If I decided to repeat this study, I would spend more time developing more influence questions and I would validate the questionnaire which means that the questionnaire is both valid and reliable. There are different types of validation methods including content, predictive, concurrent, and face validation. Content validation determines whether the questions measure what they are designed to measure (Verial 2021). A second limitation of my study is the population size. Although 98 people started the survey, 20 were ineligible and a few did not complete the survey, so they were removed from the data analysis. In the end, only 55 respondents completed the survey. This limits the generalizability of my study.
Jacobs. (1974). Developing Questionnaire Items How to Do It Well. Distributed by ERIC Clearinghouse.
Verial, D. (2021, November 20). Questionnaire validation methods. The classroom | Empowering Students in Their College Journey. Retrieved July 5, 2022, from
Through this research, I faced some difficulties in several stages. At the beginning of the search for sources from languages other than English, such as Chinese, Russian, and Portuguese, it was a challenge, but I was able to access tools that translate these sources accurately, even for large size documents. The second challenge was about the best method for evaluating the quality of the guidelines included in the study. I searched for the best methods used for this purpose in the literature and found a tool called Appraisal of Guidelines for Research and Evaluation (AGREE) to be used for quantitative evaluation of clinical practice guidelines. I tested it and proved its efficacy and accuracy in evaluating the guidelines, which facilitated the process of comparing them (Seto, 2017). Finally, the challenge I am currently working on is data analysis, as my experience is limited in this field, and I seek to find the best way to analyze the data I collected to start drawing results and conclusions.
I revised the study several times and reviewed the previous literature for similar research on other diseases to understand the methods and design used to produce useful research in the field of heart failure, especially since there is no previous study that compared the Guidelines from 6 countries for the management of heart failure. Therefore, I seek to make this study as reliable and effective as possible to be useful in its recommendations and for future research
Seto K., Matsumoto K., Kitazawa T., Fujita S., Hanaoka S., Hasegawa T. (2017) – Evaluation of clinical practice guidelines using the AGREE instrument: comparison between data obtained from AGREE I and AGREE II.