Clinical Trials and Clinical Research: A Comprehensive Review.

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.

Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent.

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.

Research Question, Objectives, and Endpoints in Clinical and Oncological Research: A Comprehensive Review.

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.

Breakthrough Infections: Clinical Profile and Outcomes of COVID-19 Vaccinated and Unvaccinated People From a Tertiary Care Hospital.

Introduction Despite the availability of a vaccine and extensive vaccination, breakthrough infections are commonly noted, which is jeopardizing the vaccine-based protection against COVID-19. The present study aims to evaluate COVID-19 breakthrough infections and to compare the clinical profile and outcomes of the vaccinated and unvaccinated populations.  Methods A retrospective observational study was conducted for two months (March-April 2021), and all cases reported during the study period were included in the study. Socio-demographic details, COVID-19 profiles, clinical outcomes, vaccination statuses, and types of vaccine were collected from the patients. Further, COVID-19-positive samples were screened for lineages using next-generation sequencing (NGS). Results Of the total 103 patients included in the study, 79 (76.7%) were symptomatic and 24 (23.3%) were asymptomatic. Only 32% were vaccinated and 68% were unvaccinated. 29.2% were hospitalized due to COVID-19 and all of them were unvaccinated. The mortality among hospitalized patients was extremely high (60%). The time to positivity after complete vaccination was noted to be 37.09±23.74 days. The unvaccinated study participants showed lower Cycle threshold (Ct) values (E Gene/N Gene: 17.38±4.53) as compared to the vaccinated people (E Gene/N Gene: 22±4.25). The Delta (B. 1.1. 629) (76.7%) was the predominant variant among the study population followed by AY.4 (20.4%) and Kappa (2.9%) variants. Conclusion Although the vaccination does not restrict/avoid infection, it appears to protect the vaccinated people from severe forms of COVID-19. Also, the higher Ct values among vaccinated people indicate that the viral load among such people may be lower and, therefore, minimizes viral transmission.

COVID-19 Era and the Constantly Reemerging Novel SARS-CoV-2 Variants Calls for Special Attention for the Geriatrics: A Real Challenge.

Global public health is significantly challenged due to the continuing COrona VIrus Disease 2019 (COVID-19) outbreak brought forth by the severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) [...].

Research Question, Objectives, and Endpoints in Clinical and Oncological Research: A Comprehensive Review

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.