ABSTRACT
Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.
ABSTRACT
Recently, we have been noticing an increase in the emergence and re-emergence of microbial infectious diseases. In the previous 100 years, there were several incidences of pandemics caused by different microbial species like the influenza virus, human immunodeficiency virus (HIV), dengue virus, severe acute respiratory syndrome Coronavirus (SARS-CoV), middle east respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2 that were responsible for severe morbidity and mortality among humans. Moreover, non-communicable diseases, including malignancies, diabetes, heart, liver, kidney, and lung diseases, have been on the rise. The medical fraternity, people, and governments all need to improve their preparedness to effectively tackle health emergencies. Clinical research, therefore, assumes increased significance in the current world and may potentially be applied to manage human health-related problems. In the current review, we describe the critical aspects of clinical research that include research designs, types of study hypotheses, errors, types of sampling, ethical concerns, and informed consent.
ABSTRACT
Clinical research is a systematic process of conducting research work to find solutions for human health-related problems. It is applied to understand the disease process and assist in the diagnosis, treatment, and prevention. Currently, we are experiencing global unrest caused by the coronavirus disease (COVID-19) pandemic. The novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) has been responsible for the deaths of more than 50 million people worldwide. Also, it has resulted in severe morbidity among the affected population. The cause of such a huge amount of influence on human health by the pandemic was the unavailability of drugs and therapeutic interventions to treat and manage the disease. Cancer is a disease condition wherein the normal cell function is deranged, and the cells multiply in an uncontrolled manner. Based on recent reports by the World Health Organization (WHO), cancer is the second leading cause of death globally. Moreover, the rates of cancers have shown an increasing trend in the past decade. Therefore, it is essential to improve the understanding concerning clinical research to address the health concerns of humans. In this review, we comprehensively discuss critical aspects of clinical research that include the research question, research objectives, patient-reported outcome measures (PROMs), intention-to-treat and per-protocol analysis, and endpoints in clinical and oncological research.
ABSTRACT
Clinical research is a systematic process of conducting research work to find solutions for human health-related problems. It is applied to understand the disease process and assist in the diagnosis, treatment, and prevention. Currently, we are experiencing global unrest caused by the coronavirus disease (COVID-19) pandemic. The novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) has been responsible for the deaths of more than 50 million people worldwide. Also, it has resulted in severe morbidity among the affected population. The cause of such a huge amount of influence on human health by the pandemic was the unavailability of drugs and therapeutic interventions to treat and manage the disease. Cancer is a disease condition wherein the normal cell function is deranged, and the cells multiply in an uncontrolled manner. Based on recent reports by the World Health Organization (WHO), cancer is the second leading cause of death globally. Moreover, the rates of cancers have shown an increasing trend in the past decade. Therefore, it is essential to improve the understanding concerning clinical research to address the health concerns of humans. In this review, we comprehensively discuss critical aspects of clinical research that include the research question, research objectives, patient-reported outcome measures (PROMs), intention-to-treat and per-protocol analysis, and endpoints in clinical and oncological research.
ABSTRACT
Background The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that emerged from the Chinese mainland has spread throughout the world affecting the normal lives of the people. Both developed and developing nations have been equally affected and coronavirus disease-19 (COVID-19) resulted in the death of millions of people worldwide. The virus is undergoing mutations and is evolving into variants that are responsible for wave after wave. This study was carried out to assess the clinical outcomes of people infected with the novel virus during the third wave of the COVID-19 pandemic in India. Methods The study was carried out between November 2021 and January 2022 and included 100 consecutive patients attending the hospital attached to the BLDE (Deemed to be University) Shri B.M. Patil Medical College, Bijapur, Karnataka, South India. All patients included in the study returned a positive report in a real-time polymerase chain reaction (RT-PCR). The patient details collected included age, sex, cycle threshold (Ct) values for envelope (E)/nucleocapsid (N), and Orf1b (open reading frame 1b) genes, hospitalization status, vaccine status, C-reactive protein (CRP), D-dimer, interleukin-6 (IL-6), and final clinical outcome. The data were entered into Microsoft Office Excel sheets, and statistical inferences were drawn using SPSS 24 (IBM Corp., Armonk, NY). Results Of the 100 patients included in the study, only 14 (14%) patients were vaccinated. The patient's mean age was 34.22±17.50. Among the vaccinated patients, the majority had taken COVISHIELD™ (85.71%) compared to COVAXIN® (14.29%). Only 14% of patients were symptomatic, and the mean Ct values among all the patients were 29.92±3.74 (E gene/N gene) and 27.6±4.78 (Orf1B gene). Eight (8%) patients were hospitalized, and all the patients recovered from the infection. Among the hospitalized patients, six (75%) were vaccinated. The mean age of the hospitalized patients was 43.8±14.25 years. The mean CRP, D-dimer, and IL-6 concentrations among the hospitalized patients were noted to be 22.375±16.58 mg/L, 654.325±577.24 ng/mL, and 5.075±2.15 ng/mL, respectively. Conclusion The study results demonstrate that despite unvaccinated status, most patients in the third wave had only suffered from asymptomatic infection. Moreover, people who developed a clinical infection and those who required hospitalization had an uneventful recovery irrespective of their vaccination status.
ABSTRACT
The human immune system is not adequately equipped to eliminate new microbes and could result in serious damage on first exposure. This is primarily attributed to the exaggerated immune response (inflammatory disease), which may prove detrimental to the host, as evidenced by SARS-CoV-2 infection. From the experiences of Novel Coronavirus Disease-19 to date, male patients are likely to suffer from high-intensity inflammation and disease severity than the female population. Hormones are considered the significant pillars of sex differences responsible for the discrepancy in immune response exhibited by males and females. Females appear to be better equipped to counter invading respiratory viral pathogens, including the novel SARS-CoV-2, than males. It can be hypothesized that females are more shielded from disease severity, probably owing to the diverse action/influence of estrogen and other sex hormones on both cellular (thymus-derived T lymphocytes) and humoral immunity (antibodies).
Subject(s)
Angiotensin-Converting Enzyme 2/immunology , COVID-19 , Estrogens/immunology , Sex Factors , COVID-19/epidemiology , COVID-19/immunology , Female , Humans , Immunity, Humoral , Male , T-Lymphocytes/cytology , T-Lymphocytes/immunologyABSTRACT
Background The significance of the global prevalence and incidence of coronavirusdisease 2019 (COVID-19) is a measure of its severity. However, without statistical data, one cannot understand the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. This study, based on good data, enables us to know how the disease is spreading, what impact the pandemic has on the lives of people around the world, and whether the countermeasures that countries have been taking are successful for controlling and preventing the disease. Therefore, this study is undertaken to estimate the infection fatality rates (IFRs) and case-fatality rates (CFRs) in various countries and regions of the world. Methods COVID-19-related data were collected from various countries belonging to different World Bank categories based on economies (low-income, low-middle income, upper-middle income, and high-income countries) and the World Health Organization's (WHO's) regional classification of countries (the Americas, European, African, South-East Asia, Eastern Mediterranean, and Western Pacific regions). The data were collected from the WHO's dedicated website on COVID-19, and statistical methods like mean, standard deviation, p-value, and percentages were used to calculate the IFR and CFR. Results Mexico (8.94%) reported the highest IFR among all the countries. The low-income countries reported increased IFR (2.46±1.91) as compared to the other groups. The European region (7.3%) and the American region (5.3%) recorded the highest CFRs. The South-East Asian region reported the lowest CFR (1.1%). Conclusions The low-income group countries showed higher rates of IFR and lower CFRs. Lower IFRs and increased CFRs were noted among the high-income group countries and the American and European regions respectively. The varied IFRs and CFRs could be attributed to multiple factors that include climatic conditions, living environments, age, sex, comorbidities, among others.