scholarly journals Clinical Trials on COVID-19: What is Being Researched in the United States?

2021 ◽  
Author(s):  
Isla Camilla Carvalho Laureano ◽  
Alessandro Leite Cavalcanti
Keyword(s):  
Public Health ◽  
United States ◽  
Clinical Trials ◽  
Sample Size ◽  
The United States ◽  
Age Group ◽  
Eligibility Criteria ◽  
Open Design ◽  
Biotechnology Companies ◽  
Pharmaceutical Biotechnology

The emergence of Coronavirus Disease 2019 (COVID-19) in late 2019 has brought great challenges to public health worldwide and, to date, there is no specific approved therapeutic protocol. Therefore, this chapter will analyze types of intervention for use in patients with COVID-19 developed by American researchers from records made on the Clinical Trials platform. For the search strategy, keywords “COVID-19” in the “Condition or Disease” section and “United States” in the “Country” section were used. No filters were applied. Data were descriptively analyzed. In total, 1,182 studies were obtained, of which 496 met the eligibility criteria. Sample size ranged from 1 to 10,000 participants. Most studies involved the age group of 18–64 years (48.6%). As for design, randomized type (80.5%), parallel (75.6%), open designs (38.7%) and those with therapeutic purpose (88.3%) were more frequent. Most clinical trials used the two-arm trial (67.3%), researched drugs (64.8%), used placebo (55.2%) and were sponsored by pharmaceutical/biotechnology companies (35.4%). Clinical trials developed by American researchers on COVID-19 involve adult and elderly participants, with predominance of randomized, parallel and open design, for therapeutic purposes and mostly evaluated immunosuppressants or combinations of antivirals/immunosuppressants. The drugs and biological products Remdesivir, Baricitinib in combination with Remdesivir, Bamlanivimab and Etesevimab, REGEN-COV and COVID-19 convalescent plasma were also used, authorized for emergency use.

PUBLIC HEALTH

PEDIATRICS ◽  
1960 ◽  
Vol 25 (2) ◽  
pp. 343-347
Author(s):  
George M. Wheatley ◽  
Stephen A. Richardson
Keyword(s):  
Public Health ◽  
United States ◽  
Cause Of Death ◽  
United States Public Health ◽  
The United States ◽  
Vital Statistics ◽  
West Germany ◽  
Medical Attention ◽  
Age Group ◽  
Number Of Children

IN ALL COUNTRIES for which there are vital statistics, accidents are a major cause of death and disability among children. In countries where the food supply is adequate and infectious diseases have been brought under control, accidents have become the leading cause of death in the age group 1 to 19 years. For example, in such countries as Australia, Canada, Sweden, West Germany, and the United States, more than one-third of all deaths in this age group are caused by accidents. The number of children who are injured by accidents fan exceeds the number who are killed. Although no accurate international figures are available, the Morbidity Survey conducted by the United States Public Health Service indicates that in the United States, for every child under 15 killed by accident, 1,100 children are injured severely enough to require medical attention or to be restricted in their activity for at least a day.

Trends in Clinical Trials Reports in Common Cancers Between 1989 and 2000

2003 ◽  
Vol 21 (9) ◽  
pp. 1850-1858 ◽  
Author(s):  
Bruce E. Hillner
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Sample Size ◽  
Financial Incentives ◽  
Cancer Biology ◽  
Pilot Trial ◽  
The United States ◽  
Evidence Based ◽  
Pilot Trials ◽  
Female Genital

Purpose: Cancer clinical trials can be dichotomized into pilot (phase I and phase II) and randomized controlled clinical trials (RCTs). The best data source for evidence-based medicine is from RCTs. However, many patients prefer to enroll onto pilot trials, and many investigators prefer to conduct or refer their patients to pilot trials. This exploratory study sought to describe the epidemiologic patterns of clinical trial reports in common cancers. Methods: A structured review was conducted of MEDLINE citations of all English clinical trials reports published between 1989 and 2000 in breast, lung, colorectal, prostate, and female genital cancers, plus leukemias and lymphomas. Each report was classified by design (RCT, pilot, or other) and country. The abstracts of RCTs were reviewed for sample size. Reports addressing screening or prevention were excluded. Results: A total of 12,035 reports, of which 3,560 were from RCTs, were found. The annual growth in RCT reports in breast, colorectal, and prostate cancer was significant (range, 4.8% to 8.5% per year) but was insignificant in leukemias, lymphomas, and female genital and lung cancers (range, 0.1% to 4.3% per year). Within each cancer, the average sample size per report did not change during the 12 years. Nonrandomized trial reports increased on average 15.1% per year (range, 10.1% to 23.2%). The United States accounted for 30% of all RCT reports and 45% of pilot trial reports. Conclusion: The faster growth in nonrandomized compared with RCT reports may reflect rapid advances in cancer biology or different structural, commercial, and financial incentives, especially in the United States compared with Europe. Unless additional studies show evidence of an increase in their quality, the modest growth in RCT reports may limit future evidence-based cancer care.

scholarly journals Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States

2019 ◽  
Vol 71 (5) ◽  
pp. 1300-1305 ◽  
Author(s):  
Laura M Smeaton ◽  
Deborah Kacanek ◽  
Kateryna Mykhalchenko ◽  
Kristine Coughlin ◽  
Karin L Klingman ◽  
...  
Keyword(s):  
United States ◽  
Human Immunodeficiency Virus ◽  
Clinical Trials ◽  
Multiple Testing ◽  
The United States ◽  
Eligibility Criterion ◽  
Eligibility Criteria ◽  
Site Characteristics ◽  
Immunodeficiency Virus ◽  
Hiv Research

Abstract Background Women are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis. Methods We conducted an analysis of screening and enrollment during 2003–2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling (“screen out”) varied by various individual, trial, or site characteristics. Results Of 10 744 persons screened, 18.9% were women. The percentages of women and men who screened out were 27.9% and 26.5%, respectively (P = .19); this small difference did not significantly vary by race, ethnicity, or age group. Most common reasons for screening out were not meeting eligibility criteria (30–35%) and opting out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing. Conclusions In the absence of evidence of significantly higher trial screen-out for women, approaching more women to screen may increase female representation in HIV trials.

scholarly journals Changes in social behavior over time in the COVID-19 pandemic

2020 ◽  
Author(s):  
Megan M Sheehan ◽  
Elizabeth R. Pfoh ◽  
Sidra Speaker ◽  
Michael B. Rothberg
Keyword(s):  
Public Health ◽  
United States ◽  
Social Behavior ◽  
The United States ◽  
Survey Study ◽  
Age Group ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Group A ◽  
Over Time

Public health recommendations aimed at limiting spread of SARS-CoV-2 have encouraged social distancing and masks as economies across the United States re-open. Understanding adherence to these guidelines will inform further efforts to reduce transmission. In this repeated cross-sectional survey study, we describe changes in social behavior in Ohio during periods of declining and rising cases. While essential activities remained consistent over time, more individuals attended gatherings of 10 or more people as cases rose, particularly in the 18-29 age group. A majority of individuals wore masks. It appears necessary to continue limiting gatherings and encourage mask-wearing, particularly among younger groups.

scholarly journals Clinical Trials Developed in Brazil on Covid-19: What Is Being Researched?

2020 ◽  
Vol 21 (12) ◽  
Author(s):  
Isla Camilla Carvalho Laureano ◽  
Alidianne Fabia Cabral Cavalcanti ◽  
Alessandro Leite Cavalcanti
Keyword(s):  
Clinical Trials ◽  
Study Design ◽  
Antithrombotic Agents ◽  
Eligibility Criteria ◽  
Clinical Trial Registration ◽  
Therapeutic Protocol ◽  
Public Health Challenges ◽  
Biotechnology Companies ◽  
Great Public Health ◽  
Pharmaceutical Biotechnology

Background: The coronavirus disease 2019 pandemic (COVID-19) has brought great public health challenges into our lives. To date, there has been no specific therapeutic protocol for this disease, which requires a study with high-quality evidence. Objectives: To analyze clinical trials on COVID-19 in Brazil. Methods: Documentary research was conducted on the clinical trial registration platform. For the search strategy, the “COVID-19” keyword was established in the “condition or disease” section and “Brazil” in the “country” section. No limit on the search period was considered. Data were analyzed and presented using descriptive statistics. Results: Of the 81 registered clinical trials, 48 met the eligibility criteria. The sample size ranged from 10 to 3,000 individuals. Most studies recruited individuals aged 18 - 64 years (48.5%) and > 65 years (48.5%). Regarding the study design, randomized (91.6%), parallel (89.5%), quadruple-blind (39.6%), and therapeutic (97.9%) types were more frequent. Most studies used standard two-arm trial (70.8%), used drugs (79.2%), placebo (58.3%), and were sponsored by pharmaceutical/biotechnology companies and universities with 33.3% and 29.2%, respectively. Conclusions: Clinical trials under development in Brazil on COVID-19 are mostly carried out with adult and elderly participants, and regarding the study design, have a predominance of randomized allocation, parallel model, quadruple-blind masking with a therapeutic purpose. Most studies use antithrombotic agents or combinations of antithrombotic agents.

scholarly journals Update From the Advisory Committee on Immunization Practices

2020 ◽  
Author(s):  
Sean T O′Leary ◽  
Yvonne A Maldonado ◽  
David W Kimberlin
Keyword(s):  
Public Health ◽  
United States ◽  
Clinical Trials ◽  
Severe Acute Respiratory Syndrome ◽  
American Academy ◽  
Advisory Committee ◽  
Vaccine Candidate ◽  
The United States ◽  
American Academy Of Pediatrics ◽  
Health Experts

Abstract The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, normally meets 3 times per year to develop recommendations for vaccine use in the United States. Because of the severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) pandemic, there are several SARS-CoV-2 vaccines currently in late-stage clinical trials, so the ACIP is now meeting monthly for single day meetings, with plans to continue standard 2- to 3-day meetings as per usual (February, June, and October). Emergency meetings of ACIP may occur if a vaccine candidate receives an Emergency Use Authorization from the food and drug administration (FDA). This Update provides a combined summary of the August 26 and September 22, 2020, meetings, both of which focused completely on Coronavirus disease 2019 (COVID-19) vaccines. The representatives from the American Academy of Pediatrics (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP.

Can We Reverse Course on Health?

Pained ◽  
2020 ◽  
pp. 7-10
Author(s):  
Michael D. Stein ◽  
Sandro Galea
Keyword(s):  
Public Health ◽  
United States ◽  
20Th Century ◽  
21St Century ◽  
Preventive Care ◽  
The United States ◽  
Health Data ◽  
Age Group ◽  
Healthy Living ◽  
Catch Up

This chapter examines whether the United States can catch up to other countries when it comes to promoting health. A 2018 paper published in the American Journal of Public Health suggests we cannot; in fact, we will fall further behind. There are three reasons for this. First, in the United States, many gains in health and survival over the first half of the 20th century slowed significantly in the latter half of the last century and the first two decades of the 21st century. Second, the United States only excels at extending life for persons over 75. In this age group, we have lower mortality than other high-income countries. But even these gains appear to be diminishing. Third, we ignore the foundational forces that shape health. Data clearly show that the United States persistently underinvests in education, efforts to promote healthy living, preventive care, and other programs and policies that address the root causes of health. Instead, we spend their money on inefficient and expensive health services.

Developing a Clinical Trials Infrastructure in the United States

2012 ◽  
Vol 2 (5) ◽  
Author(s):  
Paul Eisenberg ◽  
◽  
Petra Kaufmann ◽  
Ellen Sigal ◽  
Janet Woodcock ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States
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