Types Of Clinical Research Research Articles

Advancements in Clinical Research: Phases, Ethical Considerations, and Technological Innovations

Background: Clinical research is a vital component of medical advancements, contributing to the discovery of new treatments, procedures, and health interventions. This paper discusses the importance of clinical trials, the structure and phases of trials, ethical considerations in research, and the role of modern technologies in reshaping clinical trials. Objective: This article aims to provide a comprehensive overview of the clinical trial process, ethical compliance, and the integration of technological advancements, with real-world examples and recent studies to support the discussion. Methods: The article provides a descriptive analysis of the different types of clinical research, the various phases of clinical trials, and ethical considerations based on established guidelines such as the Declaration of Helsinki and the Belmont Report. It also examines how recent technological innovations, including AI, wearable devices, and Electronic Health Records (EHRs), have revolutionized the field. Results: The integration of technology into clinical research has resulted in more efficient, data-driven, and patient-centric trials. Ethical compliance, guided by international regulations, remains a critical factor in ensuring patient safety and maintaining public trust in clinical research. Conclusion: The future of clinical research relies heavily on technological innovation and strict adherence to ethical guidelines. As new treatments and therapies emerge, the structure of trials and the responsible use of technology will play an essential role in shaping the future of healthcare.

Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support

Structured patient data play a key role in all types of clinical research. They are often collected in study databases for research purposes. In order to describe characteristics of a next-generation study database and assess the feasibility of its implementation a proof-of-concept study in a German university hospital was performed. Key characteristics identified include FAIR access to electronic case report forms (eCRF), regulatory compliant Electronic Data Capture (EDC), an EDC with electronic health record (EHR) integration, scalable EDC for medical documentation, patient generated data, and clinical decision support. In a local case study, we then successfully implemented a next-generation study database for 19 EDC systems (n = 2217 patients) that linked to i.s.h.med (Oracle Cerner) with the local EDC system called OpenEDC. Desiderata of next-generation study databases for patient data were identified from ongoing local clinical study projects in 11 clinical departments at Heidelberg University Hospital, Germany, a major tertiary referral hospital. We compiled and analyzed feature and functionality requests submitted to the OpenEDC team between May 2021 and July 2023. Next-generation study databases are technically and clinically feasible. Further research is needed to evaluate if our approach is feasible in a multi-center setting as well.

Regulatory Prospects of Clinical Trials with Stem Cells in the United Arab Emirates

Health research and clinical trials are driving the development of valuable medical knowledge. Many types of clinical research have been conducted in the United Arab Emirates (UAE) by governmental and private health providers in recent years, and a growing number of publications and UAE-based clinical trials have been registered worldwide.

Clinical Research: An Overview of Study Types, Designs, and Their Implications in the Public Health Perspective

Human health is plagued by several challenges throughout life. Different endogenous and exogenous factors influence the well-being of humans. The endogenous factors may be the enzymes and hormonal functions that alter the normal human physiological status and cause diseases like metabolic disorders, organ dysfunctions (liver diseases, heart diseases), and several others. Also, the human immune system and the cells involved in the immune responses may be disturbed causing autoimmune disorders, and tumors/cancers/malignancies. The exogenous reasons for human illnesses may be infectious diseases caused by microbes, chemicals, toxins, and others to those humans get exposed during their lifetime. The management of such illnesses and diseases is generally carried out by qualified physicians, and surgeons, and respective clinical experts in healthcare institutions that include hospitals. The drugs, devices, and other agents used to manage human diseases are synthesized and tested exhaustively before being approved and marketed for human use for their safety and efficacy by performing clinical research. In this review, we attempt to delineate the different types of clinical research and their implications.

Promoting Ethical Payment in Human Infection Challenge Studies

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

The History of Clinical Trials Research: Implications for Oncology Nurses.

To discuss the major milestones in the history of clinical research and how these correlate with the role of the clinical research nurse. Government Web sites, published articles, and grey literature. The history of clinical research, drug development, and the regulations has come of age, and as a result clinical oncology research has a more defined scope and purpose. With the Oncology Nursing Society and the International Association of Clinical Research Nurses recognizing the scopes of practice for clinical research nursing, such roles are becoming more prevalent and integrated in oncology. It is vital for all clinical research nurses to understand and adhere to the laws and regulations related to clinical trials and human subject protection. The clinical research nurse must ensure good clinical practice and compliance with the regulations to ensure the integrity of the study. There are different types of clinical research, including behavioral, therapeutic, and nontherapeutic studies, where clinical research nurses must understand the treatments and the drug development process to better serve their patients.

Biomarkers of oxidative stress and antioxidant defense in patients with type 1 diabetes mellitus

Background: Oxidative stress has become the focus of interest in most biomedical disciplines and many types of clinical research. Increasing evidence from research on several diseases shows that oxidative stress is associated with the pathogenesis of diabetes and many other diseases. Objectives: We aimed to investigate the status of oxidative stress and antioxidant enzymes related parameters in type 1 diabetes mellitus (T1DM) patients. Patients and Methods: A total of 110 patients (70 patients newly diagnosed diabetic and 40 healthy) were studied by evaluating the level of lipid peroxidation (malondialdehyde [MDA]), nitric oxide (NO), fasting blood sugar (FBS), and glycated hemoglobin (HbA1c). Antioxidant enzymes, including superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), were also evaluated. Results: The FBS and HbA1c levels were significantly higher in diabetic patients compared to those of healthy participants. Higher levels of MDA and NO were observed in the diabetic group compared to those in the healthy participants. A significant decrease was observed in serum SOD, CAT, and GPx activities in the serum of T1DM patients by 16.7%, 72.8%, and 15.3%, respectively (P < 0.05), as compared with their activities in the controls. On the basis of sex, both male and female patients showed a significant reduction in antioxidant levels as compared to their respective controls. Conclusions: These results indicated that oxidative status and antioxidant levels were affected in T1DM. The results suggested that the biomarkers such as the plasma levels of lipid peroxidation and antioxidants in early diagnosed diabetics can be used to monitor the developing complications of the diabetes.

Fluorescence-tunable probe for antioxidant capacity assay based on dopamine self-polymerization on graphitic carbon nitride

Oxidative stress, which involved in several inflammatory and degenerative diseases, has become interesting in most of biomedical disciplines and many types of clinical research. Antioxidants can protect biological systems from the harmful effects of oxidative stress. It can reflect the monitor effect to oxidative stress from another aspect by detecting the antioxidant capacity. Therefore, it is particularly significant to assay the antioxidant capacity of biological fluids. Herein, for the first time a fluorescence-tunable probe was developed based on polydopamine-quenched fluorescent graphitic carbon nitride (g-C3N4) for assessing the antioxidant capacity of biological fluids. Dopamine (DA) can self-polymerize on the surface of g-C3N4 to produce a polydopamine (PDA) uniform coating layer in which the fluorescence of g-C3N4 is efficiently quenched by the PDA layer, showing the fluorescence “off” state. However, in the presence of antioxidants, the self-polymerized effect of DA can be effectively inhibited and leading to the fluorescence “on” state. Therefore, detecting antioxidants can be achieved by monitoring the fluorescent emission of g-C3N4. Moreover, endowed with high sensitivity and selectivity, the proposed sensing system was successfully applied to assessment antioxidant capacity in biological fluid and the results matched well with commonly used antioxidant detection method.

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators.

BackgroundThe new Clinical Trials Act that recently came into effect in Japan emphasizes the reliability of investigator-initiated clinical trials. Although Japanese clinical research coordinators have been mainly engaged in operational roles in industry-initiated clinical trials for drug approval (registration trials), broadening their contribution to cover more types of clinical research may lead to quality improvement of clinical research. To ultimately establish a clinical research infrastructure that meets the needs of the new era of Clinical Trials Act, here we gathered basic information on how clinical research coordinators might make such contributions.MethodsWe conducted a survey using self-reporting questionnaires in clinical research-related personnel to examine present status and the perspectives toward broader contribution of clinical research coordinators. The study participants were attendee of group discussion of a clinical research-related meeting in Shikoku area of Japan held in August 2017.ResultsAmong 88 participants, 69 responded (response rate: 78.4%) and 68 respondents (98.6%) were engaged in support and management of clinical research. The main area of involvement was industry-initiated registration trials (48, 69.7%), and main roles of involvement were cooperators who plays roles under the guidance of investigators (41, 59.5%). When divided by occupation into clinical research coordinators (n = 41) and other clinical research-related personnel (n = 28), approximately half of the respondents in each group replied positively to wanting broader involvement of clinical research coordinators as a clinical research professional.ConclusionThe present study revealed that about half of the clinical research coordinators and other clinical research-related personnel view a broadening of involvement of clinical research coordinators in research activities positively. Accordingly, a structured practical program aimed at encouraging such involvement may help to expand and strengthen their contribution into the future. Whether greater involvement of clinical research coordinators in clinical research will help to ensure the reliability of investigator-initiated clinical research warrants further study.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health...

후향적연구의 집단 간 동등성확보를 통한 임상자료분석

There are two types of clinical research to figure out risk factor for disease using collected data. One is prospective study to approach the subjects from the present time and the other is retrospective study to find the risk factor using the subject`s information in the past. Both approached and study design are different but the purpose of the two studies is to identify a significant difference between two groups and to find out what the variables to influence groups. Especially when comparing the two groups in clinical research, we have to look at the difference between the impact clinical variables by group while controlling the influence of the baseline characteristics variables such as age and sex. However, in the retrospective study, the difference of baseline characteristic variables can occur more frequently because the past records did not randomly assign subjects into two groups. In clinical data analysis use covariates to solve this problem. Typically, the analysis method using the analysis of covariance of variance, adjusted model, and propensity score matching method. This study is introduce the way of equality adjustment between groups data analysis using covariates in retrospective clinical studies and apply it to the recurrence of gastric cancer data.

Building practice-based research in the UK

IN recent years, the opportunities from veterinary research that uses electronic patient record (EPR) data have been increasingly recognised and, especially in the UK, application of these methods is now...

Are Children Always Vulnerable Research Participants?

International guidelines stipulate that in order for children to participate in research, consent must be obtained from their parents or guardians. This is because researchers and ethics committee members have historically viewed children as vulnerable subjects. We, the authors of this article, think that in terms of decision-making for participation in medical research, children are not always vulnerable. Vulnerability is context- and study-specific. In this article, we argue that the blanket categorisation of children as vulnerable research subjects is ethically problematic. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent, despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. Consequently, older children are under-represented in all types of clinical research. We here have illustrated our arguments using two case studies. In cases where research is important; meets international scientific and ethical standards and has been approved by relevant ethics committees; where the research team is trained to take consent; and where the information is presented in a way that is accessible to children, then children should sometimes be allowed to consent for themselves, rather than always being dependent on an adult. If children are able to provide valid consent to medical research in their own right, they should be allowed to do so, regardless of their age. The requirements for valid consent that we propose are competence, voluntariness, maturity, independence and contextual appropriateness.

Research consent from young people in resource-poor settings

Authoritative international guidelines stipulate that for minors to participate in research, consent must be obtained from their parents or guardians. Significant numbers of mature minors, particularly in low-income settings, are...

Opportunities and challenges of clinical research in the big-data era: from RCT to BCT.

At the current stage, the main types of clinical research include prospective study, retrospective study, translational research, and evidence-based study, whilethe prospective randomized controlled trial (RCT) remains the dominating research type (Figure 1). In a typical RCT, the researchers randomly divide the subjects into several groupsprovided with different interventions, and then compare the results. With a sufficient number of subjects recruited, RCTs can ensure that all the known and unknown confounding factors have the same effects on each group.

Oxidative Stress in Diabetes: Implications for Vascular and Other Complications

In recent decades, oxidative stress has become a focus of interest in most biomedical disciplines and many types of clinical research. Increasing evidence shows that oxidative stress is associated with the pathogenesis of diabetes, obesity, cancer, ageing, inflammation, neurodegenerative disorders, hypertension, apoptosis, cardiovascular diseases, and heart failure. Based on these studies, an emerging concept is that oxidative stress is the “final common pathway” through which the risk factors for several diseases exert their deleterious effects. Oxidative stress causes a complex dysregulation of cell metabolism and cell–cell homeostasis; in particular, oxidative stress plays a key role in the pathogenesis of insulin resistance and β-cell dysfunction. These are the two most relevant mechanisms in the pathophysiology of type 2 diabetes and its vascular complications, the leading cause of death in diabetic patients.

A study of free radical chemistry: their role and pathophysiological significance.

Oxygen is one of the most important molecules on Earth mainly because of the biochemical symmetry of oxygenic photosynthesis and aerobic respiration that can maintain homeostasis within our planet's biosphere. Oxygen can also produce toxic molecules, reactive oxygen species (ROS). ROS play a dual role in biological systems, since they can be either harmful or beneficial to living systems. They can be considered a double-edged sword because at moderate concentrations, nitric oxide (NO•), superoxide anion, and related reactive oxygen species play an important role as regulatory mediators in signalling processes. Many of the ROS-mediated responses actually protect the cells against oxidative stress and re-establish "redox homeostasis". On the other hand, overproduction of ROS has the potential to cause damage. In the recent decades, ROS has become a focus of interest in most biomedical disciplines and many types of clinical research. Increasing evidence from research on several diseases shows that oxidative stress is associated with the pathogenesis of diabetes mellitus, obesity, cancer, cardiovascular diseases, inflammation, ischaemia/reperfusion injury, obstructive sleep apnea, neurodegenerative disorders, hypertension and ageing.

Patient characteristics associated with venous thromboembolic events: a cohort study using pooled electronic health record data.

To demonstrate the potential of de-identified clinical data from multiple healthcare systems using different electronic health records (EHR) to be efficiently used for very large retrospective cohort studies. Data of 959 030 patients, pooled from multiple different healthcare systems with distinct EHR, were obtained. Data were standardized and normalized using common ontologies, searchable through a HIPAA-compliant, patient de-identified web application (Explore; Explorys Inc). Patients were 26 years or older seen in multiple healthcare systems from 1999 to 2011 with data from EHR. Comparing obese, tall subjects with normal body mass index, short subjects, the venous thromboembolic events (VTE) OR was 1.83 (95% CI 1.76 to 1.91) for women and 1.21 (1.10 to 1.32) for men. Weight had more effect then height on VTE. Compared with Caucasian, Hispanic/Latino subjects had a much lower risk of VTE (female OR 0.47, 0.41 to 0.55; male OR 0.24, 0.20 to 0.28) and African-Americans a substantially higher risk (female OR 1.83, 1.76 to 1.91; male OR 1.58, 1.50 to 1.66). This 13-year retrospective study of almost one million patients was performed over approximately 125 h in 11 weeks, part time by the five authors. As research informatics tools develop and more clinical data become available in EHR, it is important to study and understand unique opportunities for clinical research informatics to transform the scale and resources needed to perform certain types of clinical research. With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed with minimal resources.

Routine health insurance data for scientific research: potential and limitations of the Agis Health Database

Objective Observational studies performed within routine health care databases have the advantage of their large size and, when the aim is to assess the effect of interventions, can offer a completion to randomized controlled trials with usually small samples from experimental situations. Institutional Health Insurance Databases (HIDs) are attractive for research because of their large size, their longitudinal perspective, and their practice-based information. As they are based on financial reimbursement, the information is generally reliable. Study Design The database of one of the major insurance companies in the Netherlands, the Agis Health Database (AHD), is described in detail. Whether the AHD data sets meet the specific requirements to conduct several types of clinical studies is discussed according to the classification of the four different types of clinical research; that is, diagnostic, etiologic, prognostic, and intervention research. The potential of the AHD for these various types of research is illustrated using examples of studies recently conducted in the AHD. Conclusion HIDs such as the AHD offer large potential for several types of clinical research, in particular etiologic and intervention studies, but at present the lack of detailed clinical information is an important limitation.

Oxidative Stress, Nitric Oxide, and Diabetes

In the recent decades, oxidative stress has become focus of interest in most biomedical disciplines and many types of clinical research. Increasing evidence from research on several diseases show that oxidative stress is associated with the pathogenesis of diabetes, obesity, cancer, ageing, inflammation, neurodegenerative disorders, hypertension, apoptosis, cardiovascular diseases, and heart failure. Based on this research, the emerging concept is that oxidative stress is the "final common pathway", through which risk factors of several diseases exert their deleterious effects. Oxidative stress causes a complex dysregulation of cell metabolism and cell-cell homeostasis. In this review, we discuss the role of oxidative stress in the pathogenesis of insulin resistance and beta-cell dysfunction. These are the two most relevant mechanisms in the pathophysiology of type 2 diabetes, and in the pathogenesis of diabetic vascular complications, the leading cause of death in diabetic patients.