scholarly journals Impact of COVID-19 on clinical trials and clinical research: A systematic review

2020 ◽  
Vol 10 (3) ◽  
pp. 878-887
Author(s):  
Brijesh Sathian ◽  
Mohammad Asim ◽  
Indrajit Banerjee ◽  
Ana Beatriz Pizarro ◽  
Bedanta Roy ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Research ◽  
Negative Impact ◽  
The United States ◽  
Sudden Onset ◽  
World Health ◽  
Research Activities ◽  
The World ◽  
The Impact

Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing  a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19” AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.

scholarly journals Barriers to symptom management care pathway implementation in pediatric Cancer

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
L. Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.

scholarly journals The efficacy and safety of interferons for the treatment of patients with COVID-19: protocol for systematic review and meta-analysis of controlled trials

2021 ◽  
Author(s):  
Afsaneh Noormandi ◽  
Mohammad Fathalipour ◽  
Reza Daryabeygi-Khotbehsara ◽  
Soheil Hassanipour
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Global Pandemic ◽  
The World ◽  
Health Organization ◽  
Time Of Administration

Background and objective: COVID-19 has since been declared a global pandemic by the World Health Organization (WHO), infecting millions worldwide. The use of Interferon (INF) subtypes previously examined in the treatment of SARS and MERS is also being initiated in some clinical trials. Although different clinical trials were evaluated IFNs in the treatment of COVID-19, their efficacy and safety remain unknown. Therefore, this study aims to systematically assess IFNs efficacy and safety in treating patients with COVID-19. Methods: The protocol has been registered in the PROSPERO International Prospective Register (CRD42020200643) on 24 July 2020. This protocol has been arranged according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 checklist. Discussion: Due to lack of approved medication for the covid-19 treatment and also various mutations of this virus, evaluated the efficacy and safety of medications by various studies could help for finding treatments with high effectiveness. IFNs are one of the medications that have been administered in covid-19 infection.  Moreover, the best time of administration and dose of this medication was unknown. Although meta-analysis is a potent source for assessing the accuracy of subjects, heterogeneity of articles is a potent limitation of our work.

scholarly journals The Need for Shared Nomenclature on Racism and Related Terminology in Psychology

2021 ◽  
Vol 16 (5) ◽  
pp. 886-892
Author(s):  
Angela M. Haeny ◽  
Samantha C. Holmes ◽  
Monnica T. Williams
Keyword(s):  
Clinical Research ◽  
Negative Impact ◽  
Racial Microaggressions ◽  
The United States ◽  
Multiple Forms ◽  
Social Construct ◽  
Racial Hierarchy ◽  
The Social ◽  
The Many ◽  
The Impact

With the increased desire to engage in antiracist clinical research, there is a need for shared nomenclature on racism and related constructs to help move the science forward. This article breaks down the factors that contributed to the development and maintenance of racism (including racial microaggressions), provides examples of the many forms of racism, and describes the impact of racism for all. Specifically, in the United States, racism is based on race, a social construct that has been used to categorize people on the basis of shared physical and social features with the assumption of a racial hierarchy presumed to delineate inherent differences between groups. Racism is a system of beliefs, practices, and policies that operate to advantage those at the top of the racial hierarchy. Individual factors that contribute to racism include racial prejudices and racial discrimination. Racism can be manifested in multiple forms (e.g., cultural, scientific, social) and is both explicit and implicit. Because of the negative impact of racism on health, understanding racism informs effective approaches for eliminating racial health disparities, including a focus on the social determinants of health. Providing shared nomenclature on racism and related terminology will strengthen clinical research and practice and contribute to building a cumulative science.

scholarly journals IMPACT OF COVID 19 ON THE INDIAN STOCK MARKET

2021 ◽  
Vol 23 (07) ◽  
pp. 1085-1090
Author(s):  
Harsh Vikram Arora ◽  
Keyword(s):  
United States ◽  
Stock Market ◽  
Financial Markets ◽  
Stock Price ◽  
Stock Exchange ◽  
The United States ◽  
World Health ◽  
Health Crisis ◽  
The World ◽  
The Impact

The COVID19 pandemic which came unprecedentedly has brought forward a lot of confusion and unrest in the world. There are a lot of changes with regard to the global landscape in multiple ways. SARS-CoV-2 is the primary virus, which is the root contributor to the COVID19 outbreak, which started in Wuhan, Hubei Province, China, in December 2019. It did not take much time to spread across the world. This pandemic has resulted in a universal health crisis, along with a major decline in the global economy. One of the major reasons for the fluctuation in the stock price is supply and demand. When the number of people who want to sell their stocks outnumbers those who want to purchase it, the stock price drops. Due to the result in the gap, the financial markets will suffer in the short duration, but in the long run, markets will correct themselves and would increase again. There is a sharp decline in the stock price because of the pandemic. The current scenario has resulted in a world health crisis which has contributed to global and economic crises. Almost all financial markets across the world have been affected by the recent health crisis, with stock and bond values falling gradually and severely. In the United States, the Dow Jones and S& P 500 indices have fallen by more than 20%. The Shanghai Stock Exchange and the New York Dow Jones Stock Exchange both indicate that they had a significant impact on China’s and the United States’ financial markets. The primary purpose of this paper is to determine the impact of COVID19 on stock markets. The rapid spread of the virus has left a major impact on the global financial markets. There is a link between the pandemic and the stock market, and this has been studied in this paper. Along with it, an attempt is taken to compare stock price returns in pre-COVID19 and post-COVID19 scenarios. The stock market in India faced uncertainty during the pandemic, according to the findings.

scholarly journals A SYSTEMATIC ANALYSIS OF THE TIME COURSE TO DEVELOP TREATMENTS FOR COVID-19

2020 ◽  
Author(s):  
Binh T. Ngo ◽  
Marc S. Rendell
Keyword(s):  
Clinical Trials ◽  
Time Course ◽  
The United States ◽  
Hospitalized Patients ◽  
World Health ◽  
Published Data ◽  
Link Type ◽  
Vaccine Trials ◽  
The World ◽  
Google Search

ABSTRACTBackgroundThe spread of COVID-19 from Wuhan in China throughout the world has been alarmingly rapid. Epidemiologic techniques succeeded in containing the disease in China, but efforts were not as successful in the rest of the world, particularly the United States where there have been 2,079,592 confirmed cases with 115,484 deaths as of June 15, 2020. Projections are for continued new infections and deaths if no effective treatments can be activated over the next six months. We performed a systematic review to determine the potential time course for development of treatments and vaccines focusing on availability in the last half of 2020.MethodsPublicationsOur search was performed during the week of June 15, 2020 We reviewed up to date information from several sources to identify potential treatments for COVID-19: We used the Reagan-Udall Expanded Access Navigator COVID-19 Treatment Hub to track the efforts of companies to develop treatments. We then used the results to search for publications identified treatments on pubmed.gov and on medRxiv, the preprint server. We further used a targeted Google search to find announcements of trial results.Clinical TrialsWe searched for all investigational trials begun in the first quarter of 2020, with cut off on April 1, using several different sources: (A) covid-trials.org, then validated results on (B) clinicaltrials.gov and the (C) World Health Organization’s International Clinical Trials Registry Platform (WHO ICTRP). We focused on trials which were completed or currently recruiting for patients, reasoning that the timeline to arrive at treatments by the end of the year would require completion within the next 6 months. We excluded studies which were clearly observational, with no randomization, control or comparison group. We further set a cutoff of 100 for numbers of subjects since smaller trial size could lack statistical power to establish superiority of the intervention over the control condition.ResultsPublished DataWe found 43 publications reporting findings on 1 classes of agents. There were 12 publications related to hydroxychloroquine (HCQ),11 on tocilizumab, 4 publications related to remdesivir, four on lopanovir/ritonavir (LPV/R), four on interferons, two on favipiravir, two on convalescent plasma, one on meplazumab, one on corticosteroids, one on famotidine, and one on ivermectin. Of these, only 16 were randomized or active control studies; the rest were retrospective observational. Only two publications dealt with outpatient care, the rest all in hospitalized patients.Clinical TrialsWe found 409 trials meeting our minimum requirement of 100 subjects which were recruiting or completed. The WHO has launched the Solidarity megatrial performed in over 100 countries actively comparing HCQ, lopanovir/ritonavir (LPV/R) alone and in combination with interferon beta-1, and remdesivir. That trial is scheduled to complete enrollment in the first quarter of 2021. In addition, we found 46 trials of HCQ, 11 trials of LPV/R and 8 trials of interferons. There were 18 ongoing trials of antiviral agents, 24 immune modulator trials, 9 vaccine trials, and 62 trials of other agents. We excluded a large number of trials of Chinese traditional medications, reasoning that there was insufficient clinical experience with these agents outside China to offer these treatments to the rest of the world. Forty four trials were hoping to complete enrollment by the end of the second quarter of 2020. Of these, only 9 were conducted on outpatients. A few vaccine trials are hoping to complete Phase 3 enrollment by the end of the third quarter, but a prolonged follow-up of patients will likely be required.ConclusionRemdesivir and tocilizumab have now been granted emergency authorization in many countries for treatment of hospitalized patients. However, the disease is propagated primarily by infected ambulatory individuals. There are only a few randomized controlled studies in outpatients which can be expected to yield results in time to impact on the continuing spread of the epidemic in 2020. It will be necessary for public health authorities to make hard decisions with limited data. The choices will be hardest in dealing with potential early release of vaccines.

scholarly journals Statistical Analysis of the Performance of a Big and Open Economy: The Case of the U.S.

2018 ◽  
pp. 10-17
Author(s):  
O. V. Zhuravliov ◽  
О. М. Simachova
Keyword(s):  
United States ◽  
Open Economy ◽  
Developing Economies ◽  
Negative Impact ◽  
The United States ◽  
Us Economy ◽  
The Us ◽  
The World ◽  
Macroeconomic Indicators ◽  
The Impact

The US economy is one of the richest and most diversified economies in the world and keeps its leadership in the global economy for the past 100 years. The United States is a global leader in computer technology, pharmaceuticals and the manufacture of medical, aerospace and military equipment. And although services make up about 80% of GDP, the US remains the second largest producer of industrial goods in the world and is a leader in research and development. President Donald Trump was elected in November 2016, promising a big gap with his predecessor’s regulatory, tax and trade policies. Therefore, the current socio-economic status of the USA and the possible ways of its development in the future are interesting for studying the impact on other economies, in particular, on the Ukrainian economy and the search for new and optimal ways of developing relations between the United States and Ukraine. Key macroeconomic indicators of the US economy in 2011–2018 are analyzed, demonstrating the influence of Donald Tramp’s new policy on changes in the indicators of the economy, the labor market, trade, etc., as well as possible ways of development in the coming years. The review of key macroeconomic indicators gives grounds for classifying the American economy as healthy one. Rates of GDP growth will remain in the range of 2 to 3%. These rates of growth in the world’s largest economy are callable to ensure a substantial increase in the global activity. But uncertainties in the politics may hinder global growth and have clearly negative impact on the investment growth in developed and developing economies.

scholarly journals The Impact of the World Health Organization Essential Newborn Package on Newborn Care Practices and Survival Rates in Sub-Saharan Africa: A Systematic Literature Review

2019 ◽  
Vol 9 (1) ◽  
pp. 19-29
Author(s):  
Andy Emmanuel ◽  
Victoria Kain ◽  
Elizabeth Forster
Keyword(s):  
Systematic Review ◽  
Health Workers ◽  
Newborn Care ◽  
Sub Saharan Africa ◽  
World Health ◽  
Essential Newborn Care ◽  
The World ◽  
Sub Saharan ◽  
Health Organization ◽  
The Impact

Sub-Saharan Africa, has the highest child mortality rate in the world (World Health Organization [WHO], 2016). However, there is a paucity of current systematic reviews on the impact of essential newborn care interventions in Africa. Therefore, the aim of this systematic review was to summarize evidence about the impact of essential newborn care interventions in Africa. Numerous databases were searched to retrieve articles that reported interventions in newborn care in Africa. The search was limited to the English language and to articles published between 2007 and 2017. Nine articles were selected for inclusion in this systematic review. Overall, these papers demonstrated an increase in performance of health workers (between 8 and 400%) following a test of knowledge, while health workers practical performance increased by 34%. Moreover, neonatal mortality was reduced by 45%, while perinatal mortality was reduced by 30%. Training healthcare workers is one of the most effective ways of improving newborn care and neonatal survival in Africa. However, there is a need for additional evidence to support this, because none of the reviewed studies assessed the impact of training by examining variables such as trainees' satisfaction with training, the knowledge and skills developed, and the health outcomes achieved.

scholarly journals Impact of Covid-19 on Stock Market in Sub-Saharan Africa

2021 ◽  
Vol 1 (2) ◽  
pp. 41-70
Author(s):  
Saifullahi Adam Bayero ◽  
Babangida Danladi Safiyanu ◽  
Zaitun Sanusi Bakabe
Keyword(s):  
Stock Markets ◽  
Negative Impact ◽  
Virus Disease ◽  
Selection Criterion ◽  
Sub Saharan Africa ◽  
World Health ◽  
African Countries ◽  
The World ◽  
Sub Saharan ◽  
The Impact

Corona virus disease (COVID-19) which was declared by the World Health Organization as a global pandemic caused serious economic problem to all the countries including Sub-Saharan Africa. Given the negative impact of COVID19 on the world economy, this paper examined the impact of COVID19 related cases and death on stock exchange markets volatility in Sub-Saharan African countries. The study used the number of reported cases and death from four Sub-Saharan African countries viz Nigeria, South Africa, Kenya, and Botswana, reported cases and death from China and U.S. and all share index as a proxy of stock markets in four countries from 28 February 2020 to 21 December 2020. The study estimated GARCH 11, TGARCH 11, and EGARCH 11 since the variables are heteroskadestic in nature which makes the application of ARCH lausible; the selection criterion was based on Akaike, Schwarz, and Hannan info Criteria. The result shows that COVID19 confirmed cases and death do not affect the operation of the stock markets in Sub-Saharan African countries, but the volatility of the markets has increased within the period of analysis. Furthermore, Botswana and Kenya stock markets were affected by external cases from China. We therefore recommended that stock markets stakeholders in Sub-Saharan Africa should be more concern about health safety measures and be ready for any future pandemic that might affect the markets.

Impact of COVID-19 on Mental Dimension of Health: A Sensitive Issue to be Addressed at the Earliest

2021 ◽  
Vol 16 (3) ◽  
pp. 158-166
Author(s):  
Sunil Nepal ◽  
Sudip Nepal ◽  
Chakrakodi S. Shastry ◽  
Sharad Chand ◽  
U.P. Nandakumar ◽  
...  
Keyword(s):  
Mental Health ◽  
Negative Impact ◽  
Virus Disease ◽  
Global Mental Health ◽  
High Stress ◽  
World Health ◽  
Frontline Workers ◽  
Increased Risk ◽  
The World ◽  
The Impact

Background: The novel coronavirus disease outbreak of 2019 was declared as a public health emergency by the World Health Organization. At present, the virus has spread throughout the world, leading to millions of cases and is further increasing. Objective: The main objective of this study is to review the impact of Corona Virus Disease 2019 (COVID-19) on the mental health of frontline workers, isolated and quarantined people and the general population. Methods: The relevant articles were extracted from PubMed, Web of Science and ScienceDirect database by using the keywords “Mental health”, “COVID-19”, “Impact of COVID-19”, “Frontline workers”, “Quarantine”, “Isolation”, “Immunity” and “Economy”. The retrieved articles were included in the study based on inclusion criteria to perform the review. All the selected scientific articles were critically reviewed and the information is summarized in this narrative review. Results: The majority of the studies stated that frontline health workers were at an increased risk of depression. The infected, suspects and quarantined people were reported with high stress, posttraumatic stress disorder, and suicidal thoughts. The pandemic has devastated the world’s economy, which has severely impacted global mental health. Conclusion: Mental health should be taken into account, and necessary interventional initiatives need to be considered both by the health authorities and the government to minimize the adversity of the consequences. The pandemic may disappear with the discovery of new vaccines or medications, but its negative impact on mental health may persist, particularly among vulnerable populations. Thus, mental health must be a matter of concern in the present scenario.

A national survey on patients’ enrollment rate in oncology clinical trials: The French experience.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17567-e17567
Author(s):  
Iris Pauporte ◽  
Valerie Thibaudeau ◽  
Fabien M. Calvo ◽  
Agnes Buzyn
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Public Investment ◽  
University Hospitals ◽  
Public Intervention ◽  
Therapeutic Trials ◽  
Research Activities ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
The Impact

e17567 Background: The rate of patients enrolled in clinical trials (CT) is one of the main indicators of clinical research and care activity. The successive French Cancer Plans (2003-2007 and 2009-2013) aimed at quantifiable targets of patients to be enrolled in high-quality clinical trials. To help investigators achieving this objective, a substantial financial support for clinical research associates (CRA) recruitment was given to University Hospitals (UH), Comprehensive Cancer Centers (CCC) and public or private community hospitals (CH). In the meantime, significant public investment was allocated to competitively selected academic projects through the Clinical Research National Program. Methods: From 2006 to 2011, we carried out annual national surveys on clinical research activities in oncology in France. A questionnaire was sent to cancer care institutions. Number of CT open for enrolment, number of CT sponsored by the institution, number of patients enrolled and human resources (CRA) were collected. Academic and industry-sponsored trials were analyzed separately. Results: We showed that the number of patients enrolled in CT increased continuously over this period: from 21,500 in 2002 to 35,400 in 2011 (+47%). Based on these figures and assuming that there were 420,000 to 472,000 patients eligible for CT over this period, the enrolment rate for patients in CT is estimated to be 7.5 to 8.5% in 2011 versus 5.8 to 6.7% in 2003. Nearly 80% of all enrolled patients were recruited in academic CT; over 75% of patients in therapeutic trials. UH and CCC equally contributed for 80% of enrolment, CH for the residual 20%. At last, the number of CT increased by more than 35% over the same period, while the number of CRA was multiplied by 3 over the French territory. Conclusions: Our results show that public intervention for improving enrolment to cancer CT seems to be efficient. Other types of intervention are being considered, i.e., targeted on investigators, on patients, or on both. Future work should also consider the impact of CT enrolment on patients’ outcome.

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