Introduction
A clinical trial is a study of people to evaluate a medical, surgical, or behavioral procedure. These are the main methods researchers use to appraise the protection and effectiveness of new therapies in humans, including medications, foods, and medical equipment like pacemakers. Drug studies are frequently conducted to ascertain whether new therapies are more efficient and have fewer adverse side effects than traditional medications (Chekroud et al., 2021). Several clinical studies investigate ways to detect the disease early before symptoms appear. Clinical trials are essential since they can focus on improving the quality of life for people with ongoing health problems or terminal illnesses.
This study is significant since it examines the connection between clinical trials and medical research.
Humanistic Nursing Theory
The humanistic nursing theory involves calls for help from one or more individuals (family, community, humanity) and responses to those calls when identified by a group of therapists or caregivers. People talk to each other to address their health-related needs. Nursing is, more specifically, “the ability to combat others through supreme experiences related to health and suffering that enable participants to become attuned and aligned with human potential”(Fawcett, 2020). It is a loving practice that promotes the well-being of those who need it (Fawcett, 2020). Respect for all living things and humanism are the basis of care. Humanistic nursing promotes healing through a mutual, personal connection between nurses and patients. Its distinguishing features include empathy, respect for human dignity, kindness, patient autonomy, a welcoming environment, and comprehensive treatment.
A humanistic approach to nursing encourages nurses to grow professionally, increases satisfaction, and helps them realize their values. With the rapid development of medical technology and the introduction of cutting-edge technology to save patients’ lives, the intensive care unit (CCU) is now one of the hospital’s busiest wards. Nurses must improve the overuse of mechanical devices and repetitive processes in these facilities to ensure human values-based care. A patient experiences humanistic behavior in her ICU, but these facilities still need to improve their humanistic approach and pay more attention to patients’ basic needs and poor communication. On the other hand, there is some evidence that critical care nurses (CCNs) are addressing complex and unresolved patient care concerns (Fawcett, 2020).
These issues demonstrate how vital the care provided by the CCU is to combine knowledge, skill, and humanity. As reward is an essential factor influencing behavior, investigating and demonstrating the benefits of humanistic care in CCUs can encourage CCNs to adopt more humanistic behaviors.
Review of the Literature
Due to the dynamics of medicine, dreadful diseases repeatedly threaten patients’ quality of life. Communities are at risk when new diseases emerge and require immediate medical attention. The health issue that shocked the world’s most advanced medical institutions was COVID-19. Medical research is essential to discovering cures for diseases in time to save lives (Ahuja et al., 2020). Clinical trials are further medical research focused on detecting, preventing, and treating disease. Understanding the genetic makeup of diseases and developing treatments to address those problems are two essential uses of clinical trials. Nurses can use this research to identify more effective treatments for diseases. The authors look forward to the contributions that clinical trials make to medical research and the benefits of real-world trials.
There are four stages of clinical trials used to evaluate drugs, determine appropriate dosages, and look for side effects. Once studies conducted in the first three phases show a treatment to be safe and effective, the FDA will approve the treatment for clinical use and track its impact. The FDA often has to decide whether to approve a drug for use after Phase I, II, and III trials (Types and Phases of Clinical Trials, n.d.). Investigational treatments are evaluated in Phase I trials in small, usually healthy populations (20-80 people) to determine their safety, side effects, and optimal dosage (Types and Phases of Clinical Trials, n.d.).
More people will be enrolled in the Phase II trial (100-300) (Types and Phases of Clinical Trials, n.d.). Phase I focuses on security, while Phase II focuses on effectiveness. This step attempts to collect preliminary data on the efficacy of a drug in patients with a particular disease or condition. These studies are safety studies that include short-term side effects. This stage can last for years.
Phase III trials evaluate drugs in different groups, with different dosages, and in combination with other treatments. The FDA approves an experimental drug or technology if the FDA deems the research results to be promising. After the FDA approves the use of a medicine or device, a Phase IV trial is conducted. The efficiency and safety of a gadget or medication are evaluated in sizable, diverse groups. A drug’s adverse effects will not always be apparent until more people have used it for extended periods. People decide to participate in clinical trials for a variety of reasons. Some people enroll in a study because the treatments they have tried to treat their health issues have failed. Others take part since there is no cure for their medical condition.
Participants in clinical trials could learn about novel medicines before they are generally made available. Some studies are made for or include individuals who are in good health but want to contribute to the search for cures for diseases that may run in their families. Several assert that participating in clinical trials enables them to take a more active role in their healthcare. Some assert that they want to help researchers understand more about particular health conditions (Types and Phases of Clinical Trials, n.d.). Regardless of one’s reasons, participating in a clinical trial is part of scientific research. Also, a person’s support may contribute to healthier lives for future generations. Significant medical advancements would not have been possible without the generosity of clinical trial participants, whether young or old.
Synthesis of the Research Findings
Clinical research’s overarching objective is to lay the scientific groundwork for disease treatment. The health belief model provides the primary framework for determining a person’s health state and is the critical theory utilized in a clinical trial. The model consists of five main models: perceived barriers, personal self, perception cues to action, and assessing the severity of a problem. The practitioners can review clinical trials and ensure they fulfill the research goals for better results by understanding the theory better. According to Oxford et al. (2020), clinical trials are intended to help determine the disease’s status and outline the best course for producing a particular antidote. Cook et al. (2019) added that clinical trials were crucial for modifying more practical medications. The ARV was developed to generate safe and more effective treatment, and clinical trials were essential. Clinical trials are the only reliable technique to identify the root cause and provide treatment for many diseases in the future.
Clinical examinations typically precede medical therapy in hospitals. Clinical trials provide the foundation for advancing innovative therapeutics in the healthcare field, according to Minesh and Chakraborty (2021). People voluntarily participate in search trials to help develop primary treatments. Many medical diseases can be assessed and treated to ascertain whether the current medication works. The results concur with Gray et al. (2021), who claimed that clinical trials are crucial for developing new medications and involving the public. Participating in the community ensures that individuals know the risk factors for various diseases and the solutions to healthcare obstacles. Del Paggio et al. (2021) examined how clinical trials have changed in American oncology since the 1970s. The study concentrated on the oncology division and the significance of randomized clinical trials in developing the therapy. The data suggested that more extraordinary medical results have emerged since the development and advancement of clinical trials.
When more samples are used for randomized trials, efficiency is directly proportional to the number of trials conducted. Therefore, ensuring that all clinical research is linked to a framework for conducting experimental hypothesis tests is crucial. Gray et al. (2021) argued that clinical trials might put people’s lives in danger, despite Cook et al. (2019) data suggesting that they are the safest way to find the cure for a medical disease. Most trials employ human samples, which necessitate several tests to pinpoint the disease’s origins and the indicated treatment. Putative surrogates are crucial to the success of both clinical trials and must be involved if improved results are to be obtained. Del Paggio et al. (2021) and Oxford et al. (2020) studies suggested that more comprehensive clinical trials that assess every aspect of the disease could yield better outcomes. People are more likely to get better outcomes when the studies are carried out among diverse groups. Because different infections occur in different situations today, each geographical area needs its own testing.
It is crucial to remember that the study conducted and examined demonstrated the value of clinical trials in medical research. Most conclusions focused on how technological developments have altered the medical industry. The aspect that nurses should include is how facilities may enhance clinical trials for higher-caliber medical research. The condition’s progression can only be understood when there are more studies because the study’s primary goal is to enhance medical research through improved clinical trials in managing hypertension. The analysis could produce reliable conclusions and sound medical effects with the samples.
Nurses must make clinical trial adjustments to produce superior products. The conclusion made by Gray et al. conflicts with the study by Minesh and Chakraborty (2021), which claimed that the samples needed to be evaluated using statistical methods (2021). The latter research pointed out that because each demographic has a different outcome, it is crucial to make sure each community receives a unique test for the trials. The most excellent method to enhance clinical trials and ultimately provide more accurate results is to address the apparent knowledge gap.
One of the most complex medical issues is the treatment of illnesses of the central nervous system. However, ongoing research has suggested that clinical trials are necessary to comprehend all different CNS disorders and that creating an antidote is simple (Oxford et al., 2020). The clinical studies help doctors comprehend the disease-causing microorganisms and potential gene mutations. A suitable standard operating procedure must be made available to standardize all trials since some depend solely on the endpoint. Clinical trials have undergone significant changes that must be taken into account. In order to guarantee that clinical trials provide the most likely outcomes in the discussion, regulation is essential. The most advanced types of clinical trials, randomized clinical trials, must be used to get reliable study results (Del Paggio et al., 2021). Having correct test procedures is the first step in advancing medical research.
Clinical trial advancement is anticipated to have repercussions for medical research. Clinical trial patient recruitment is still a significant difficulty, with 17% of trials ending because of insufficient enrollment and another 33% requiring more extended recruiting periods (Darmawan, 2020). Clinical trial delays and cancellations profoundly affect patients, researchers, and society on the scientific, ethical, and monetary levels. Terminating clinical trials because of recruitment problems prevents the gathering of the data required to evaluate an intervention’s efficacy, safety, and effectiveness, which may delay the introduction of a more promising therapy or permit the continued use of an outdated, ineffective standard therapy. From an ethical standpoint, study termination subjects recruited patients to needless risks and inconveniences since it cannot provide enough data.
Researchers’ morale is poorer when projects are delayed or terminated, which may affect society’s trust and desire to support medical research in the future. Darmawan conducted a thorough works search across seven platforms to find clinical studies that utilized both conventional and social media to find patients (Darmawan, 2020). The evaluation and comparison of study and participant characteristics, recruitment strategies, and recruitment results. Even though there is mixed reporting regarding the use of social media to boost clinical trial participation, preliminary studies show that it can increase participation and reduce per-participant expenditures. Establishing standardized standards for publishing recruiting and participation results is vital to improving our understanding and use of social media to aid clinical trial success.
It is both morally and scientifically necessary to increase clinical trial diversity. Assessing the effectiveness and safety of innovative medicines across demographic subgroups is hampered by a lack of diversity, which is essential for eradicating inequities and improving equity. Furthermore, it is detrimental that minority racial and ethnic groups remain strikingly underrepresented in therapeutic studies. However, roughly 40% of Americans are members of minority racial or ethnic groups, and 75% of the 32,000 people took part in the clinical trials for the 53 innovative medications (Gray et al., 2021). The excessive burden of permanent disease in the minority racial and ethnic minorities for whom drug studies potentially bring life-saving medicines contrasts sharply with the overrepresentation of White volunteers. Black people account for just most of the participants in pancreatic cancer clinical trials yet receive 12 percent of cancer diagnoses in the United States.
Critique of the Previous Research Methods
The purpose of the earlier study was to highlight the advantages of clinical trials in medical research. Nevertheless, the procedures used had flaws that put the results in jeopardy. According to a report by Minesh and Chakraborty published in 2021, clinical trials are crucial to advancing medical research and creating new medications. The research methods, however, used volunteers who were enthusiastic about developing new medications. However, since the diseases’ side effects are likely to affect people, utilizing volunteers impacts their quality of life. Before the new treatment is made available, research and testing will only be done on samples. Cook et al. (2019) used statistical analysis to conclude the interpretation of the data. However, because the sample size needed to be larger, the methodology needed to have the necessary validity. There was no way to apply the findings to other developments. Statistical validity and reliability are required to guarantee that the clinical study results are productive. So, to benefit medical research, this study will ensure that the trials are trustworthy, legitimate, and accurate.
Summary
Clinical trials are the foundation for creating treatments and cures for numerous diseases. Modern medicine has developed mainly due to the creation of randomized controlled trials (Oxford et al., 2020). The development of medications for hypertension, Alzheimer’s disease, and other severe illnesses like the COVID-19 pandemic has significantly benefited from clinical trials. Unreliability, smaller sample sizes, societal opinions, and traditions are important hurdles in clinical trials. A bigger research model and an understanding of the populations are essential for enhancing the reliability of clinical studies (Del Paggio et al., 2021). Separate trials are needed for various geographical areas with various diseases. The investigation of clinical trials and their enhancement will significantly impact medical research. Clinical research can be improved when clinical trials are enhanced to serve as the cornerstone of precise data collecting.
Background
The prior study’s objective was to emphasize the benefits of clinical trials in medical research. However, there were problems with the methods that made the outcomes uncertain. Nonetheless, the volunteers who participated in the research were passionate about finding new medicines. However, because people are likely to be affected by the adverse effects of the diseases, using volunteers lowers their quality of life. Designing clinical trials with consideration for beliefs, norms, and sustainability will help to guarantee that they add value to the debate. Bidirectional feedback is essential to ensure that clinical trials contribute to medical research.
Clinical research that uses randomization has been found to produce the most reliable results. However, because the random population only includes sufficient individuals, it is likely to produce inaccurate results. Del Paggio et al. (2021) examined the development of randomized clinical trials and suggested ways to enhance them for better and more effective medical research. However, oncology has seen a rise in precision anytime the research sample size was raised to produce more detailed findings. Using samples in isolation from the developed research on clinical trials was the most significant barrier to the study approach. However, the research gap may be filled by ensuring the study sample is enlarged, and reliability is examined before the final results can be used as research data.
The norms of the individuals who were impacted by the clinical study caused problems for the research by Gray et al. (2021). The technique challenge can be ameliorated by ensuring that the populace is informed and planning exams according to cultural norms and customs. To ensure that clinical trials bring value to the discourse, the beliefs, norms, and sustainability must be considered when designing clinical trials. To ensure that clinical trials contribute to medical research, bidirectional feedback is even more critical. Oxford et al. (2020) looked into the potential use of clinical trials to find a treatment for Alzheimer’s disease. The fundamental difficulty with the methodology was the requirement that the animal models be suitable for assessing human efficacy. People must be informed, and their expectations must be low before the clinical study to achieve successful outcomes.
Research Problem
A variety of obstacles in clinical trials, such as expert mistrust, trial administration, access, eligibility, recruitment methods, and unfavorable views, norms, and attitudes, pose significant obstacles, but they are adjustable. To achieve this, suggested treatments have mainly concentrated on the system-, patient-, and provider-level change (Gray et al., 2021). They have yet to produce widespread environmentally friendly and scalable solutions. The researchers consider these partners’ involvement and reciprocal feedback, as well as that of other stakeholders like the community, the government, and the pharmaceutical sector, to be essential and lacking elements. Meaningful collaborations to establish trust, co-create approaches, and answers, and take the initiative for collective effect are at the heart of community engagement. A fantastic chance to foster and maintain clinical trial diversity exists when academia, the community, administration, and industry collaborate. Although most researchers focus on clinical trials, they have not focused more on the roles clinical trials play in advancing medical research.
Research Question
The research question states, “What are the roles of clinical trials in advancing medical research?” while the hypothesis states that clinical trials play essential roles in medical research, the null alternative states that clinical trials do not contribute to significant roles in medical studies. The alternative hypothesis states that medical studies are the primary method researchers use to determine whether a new therapy, such as a new medicine, diet, or healthcare gadget, is compelling.
Goals and Objectives
The goals of this study include exploring the roles of clinical trials in advancing medical research, the importance of clinical trials in medicine, and the benefits clinical trials offer in drug development. The objectives of this goal include establishing clinical trial roles, medical benefits, and drug development importance, respectively.
Population and Sample
This study will take place in a hospital setting. The general population to be included in the study are nurse physicians, one scientific nurse expert, one physician associate, and five pharmacologists, giving 40 participants. The target population is comprised of nurse experts primarily involved in medical studies. Nurse physicians will be the sample since they are the most engaged in clinical trials. While selecting the physicians who will be used as the sample, the researcher will utilize a random sampling method. Individuals from a population are chosen randomly by the researcher using a method based on random sampling.
Every individual in the community has the same probability of being picked. After that, data are gathered from as many of these randomly selected data points as possible. The following criteria will be met for a participant to qualify: participants will be older than 18 years old, have been unintentionally admitted to the hospital within the previous 12 months, have been diagnosed with any disorder, and have had their decision-making capacity evaluated by a psychiatrist. Being deemed unable to provide informed consent and being under tutelage were among the exclusion criteria.
Methodology and Procedures
Quantitative Research
The experimental quantitative research design will play a vital role in this research. This design is appropriate to the research question since it will enable the scholar to understand better how the information related to the research topic was gathered and, consequently, aid in conducting an accurate analysis of the findings.
Instruments. The researcher will utilize questionnaires as the instruments to conduct the study. Web-based questionnaires are significantly cheaper than in-person, on-site, telephone, or mail surveys, as there are no labor, paper, printing, telephone, or mail costs. Communicate quickly with the respondents by distributing their surveys through various channels, including Providing an SMS, message, link to a website, or a downloadable QR code. Surveys come in various formats: natural, rating-based, checkbox, and free-text responses. However, surveys have many pros and cons, which we have covered in this post. The Internet enables individuals to efficiently target people worldwide and swiftly expand their market for web-based surveys. This can be accomplished by automated email as part of a campaign for lead nurturing or customer onboarding.
When attempting to poll respondents on sensitive topics, providing confidentiality to web-based questionnaires is a considerable advantage over other options, such as face-to-face or telephone interaction. Respondents are instantly reassured and encouraged to answer when anonymity is provided. When asking people about their cultural organization. A unique aspect of online surveys is that participants can choose when and where to complete the questionnaire. People get a better overall response rate if they have more time to finish their outline and, curiously enough, the option to commence and finish later. Internet-based surveys frequently embed respondents’ answers in accounting webpages, application software, or other computer packages. Unlike face-to-face and telephone, online surveys require analysts to process informants’ responses. This lowers the likelihood of human error and makes data approval by computers possible.
Data Collection. The examiner will first write a letter to the hospital management requesting permission to conduct the study. After the researcher is granted permission by the facility administrator, he will use a survey data collection technique to conduct this study. The most common data collection techniques in research studies are questionnaires and interviews. Professionally or self-administered questionnaires, conducted singly or in groups, usually contain several elements that reflect the research goals. Surveys can ask for demographic data in addition to using reliable and accurate survey tools. To allow the reader to interpret and evaluate the possibility of validity and reliability errors. The literature contains valuable examples of work describing research equipment.
Data Analysis. The researcher will use statistical analysis to analyze the research findings. The procedure the scholar will employ includes writing the hypothesis, collecting data, summarizing the information, testing the hypothesis, and interpreting the findings. Organizations can identify spending trends and perform more accurate cost and data investigations through statistical analysis. After getting this information, businesses can gain insight into projected future spending or cost-cutting actions to control spending and reduce waste. Statistical analysis allows companies to conduct proper market research. Data can indicate the most common locations for transactions, the most expensive locations, and the types of promotions accompanying those purchases. It makes it possible for all aspects of marketing and sales to be more effective.
Conclusion
Clinical research, which includes clinical trials, is the basis of all medical progress. Clinical trials examine new approaches to prevent, diagnose, or treat disease. Treatment may include new drugs or combinations, new surgical techniques or medical devices, or new applications of current treatments. Clinical trials are intended to determine the efficacy and safety of new diagnostic or therapeutic approaches. Clinical trials can test different treatment aspects, improving patients’ quality of life with long-term illnesses. Researchers can learn about what works and what does not in humans through clinical trials that nurses cannot discover in laboratory or animal studies. It helps determine whether it is acceptable compared to its potential benefits. The results of clinical studies have yet to be discovered by researchers. (A trial is not required in this case.)
Because of this ambiguity, deciding whether a patient will participate in a clinical trial can take time and effort. Various people have benefited from their predecessors’ voluntary participation in research, which has led to the development of new, more effective treatments.
References
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