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2.
J Clin Epidemiol ; 143: 73-80, 2022 03.
Article in English | MEDLINE | ID: covidwho-1509965

ABSTRACT

OBJECTIVE: We sought to map the landscape of trials investigating hydroxychloroquine (HCQ) for SARS-CoV-2 in order to draw conclusions about how clinical trials have been conducted in the pandemic environment and offer potential regulatory recommendations. STUDY DESIGN AND SETTING: We identified and captured data related to registered studies using HCQ to treat SARS-CoV-2 registered with the publicly available National Institutes of Health (NIH) Clinical Trials Registry between February and November 2020. RESULTS: Between February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10). CONCLUSION: Many clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.


Subject(s)
COVID-19 , Clinical Trials as Topic , Hydroxychloroquine , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/epidemiology , Clinical Trials as Topic/ethics , Humans , Hydroxychloroquine/therapeutic use , National Institutes of Health (U.S.) , Registries , SARS-CoV-2 , United States/epidemiology
7.
JAMA Intern Med ; 181(8): 1031-1032, 2021 08 01.
Article in English | MEDLINE | ID: covidwho-1258011
8.
Clin Ther ; 43(6): e163-e172, 2021 06.
Article in English | MEDLINE | ID: covidwho-1240250

ABSTRACT

Young children will ultimately need to be vaccinated to stop the spread of coronavirus disease 2019 (COVID-19). Initial studies of vaccine were performed in adults. Randomized controlled trials are the gold standard. In the COVID-19 pandemic, many questions need to be answered about the ethics and feasibility of these trials. Given the harms of the COVID-19 pandemic and the now-known efficacy of the vaccines in adults and teens, the question of whether clinical equipoise exists for a placebo-controlled trial of vaccines in younger children remains. Parents may be reluctant to enroll children in these trials because they want their child to receive the vaccine or because they are worried about vaccines or clinical trials in general. One option for gathering data on tolerability and efficacy in children would be to use a nonrandomized trial to enroll parents willing to vaccinate their children and those who are hesitant. We discuss the advantages and disadvantages of such an open-label trial that could provide guidance for future pandemics. (Clin Ther.


Subject(s)
COVID-19 Vaccines , COVID-19 , Clinical Trials as Topic , Pandemics , COVID-19/epidemiology , COVID-19/prevention & control , Child , Child, Preschool , Clinical Trials as Topic/ethics , Ethical Analysis , Humans , Pandemics/prevention & control , SARS-CoV-2
9.
Indian J Med Ethics ; VI(2): 1-10, 2021.
Article in English | MEDLINE | ID: covidwho-1206593

ABSTRACT

This article compares the current debate over the use of placebos in developing country clinical trials of second generation Covid-19 vaccines with the debates over previous paradigmatic cases raising similar issues. Compared to the earlier zidovudine and Surfaxin trials, Covid-19 vaccine trials are likely to confer lower risk to placebo groups and to offer a greater number and variety of alternative study designs. However, turning to the developing world to conduct studies that would be unacceptable in developed countries, simply on the ground that Covid-19 vaccines are generally unavailable in developing countries, is not ethically justifiable. This is so whether the justification is rooted in total absence of vaccine in a given country or in developing country vaccine prioritisation practices, because at root both derive from economic, not scientific conditions. However, the advent of variants that may create genuine uncertainty as to comparator vaccine effectiveness could justify a placebo control, depending on vaccine characteristics, variant prevalence, the degree of variant resistance, and the acceptability of immune-bridging studies. These factors must be considered together in the necessary case-by-case assessment of the ethical justification for any proposed trial.


Subject(s)
COVID-19 Vaccines/standards , COVID-19/prevention & control , Clinical Trials as Topic/ethics , Clinical Trials as Topic/standards , Ethics, Medical , Patient Rights/standards , Placebos/standards , Adult , Aged , Aged, 80 and over , Developing Countries , Female , Guidelines as Topic , Humans , Male , Middle Aged , Pandemics , Risk Factors , SARS-CoV-2
10.
Indian J Med Ethics ; VI(2): 1-7, 2021.
Article in English | MEDLINE | ID: covidwho-1206589

ABSTRACT

Recently the WHO Ad Hoc Expert Group proposed that it is ethical to continue placebo-controlled Covid-19 vaccine trials in countries where vaccines are not available even if this vaccine is marketed and being used elsewhere. The reason for this proposal is the usual scientific argument claiming that these trials are the most efficient method to obtain reliable results, and individuals in these countries will continue to get the local standard of care, meaning no vaccination, and thus participants are not being left worse off. We refute this argument on two counts. First the global equity and justice issue, that the scarcity of vaccines in most countries is created by the rich nations that have hoarded vaccines. Second, the science versus research ethics issue, that there are valid scientific methods like non-inferiority trials which can give reliable results, and that applying a standard of care imposed by rich nations is both unethical and possibly exploitative. Thus, we feel that the WHO Ad Hoc Expert Group is wrong in proposing to continue placebo-controlled Covid-19 vaccine trials.


Subject(s)
COVID-19 Vaccines/standards , COVID-19/prevention & control , Clinical Trials as Topic/ethics , Clinical Trials as Topic/standards , Ethics, Medical , Human Rights , Placebos/standards , Guidelines as Topic , Humans , Pandemics , SARS-CoV-2
11.
Indian J Med Ethics ; VI(2): 1-7, 2021.
Article in English | MEDLINE | ID: covidwho-1206586

ABSTRACT

Thanks to an impressive R&D effort, three vaccines for Covid-19 have been conditionally approved by stringent regulators as of February 2021, and sixteen have entered the WHO evaluation process. However, they all need to keep on being evaluated in clinical trials. The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine suggested that countries with limited or no access to an effective vaccine could ethically permit placebo-controlled trials, even if effective vaccines were already being marketed elsewhere. Here, I argue that inclusion in a placebo-controlled trial is ethically sound for those who would be in any case ineligible for vaccination outside the trial, and as long as the access to the vaccine outside the trial depends on a transparent and just allocation framework. Conversely, carrying out placebo-controlled studies in countries where vaccines are not (or are insufficiently) available because of unequal global allocation, would be unethical, as an ethical strategy cannot be built on an unethical premise.


Subject(s)
COVID-19 Vaccines/standards , COVID-19/prevention & control , Clinical Trials as Topic/ethics , Clinical Trials as Topic/standards , Ethics, Medical , Guidelines as Topic , Placebos/standards , Humans , Pandemics , SARS-CoV-2
13.
Ethics Hum Res ; 43(3): 37-41, 2021 May.
Article in English | MEDLINE | ID: covidwho-1173806

ABSTRACT

In the midst of the ongoing Covid-19 pandemic, researchers across the globe are still working to develop effective vaccines. To expedite this process even further, human challenge trials have been proposed by the World Health Organization (WHO) as an alternative to conventional approaches. In such trials, healthy volunteers are deliberately infected with the pathogen of interest, enabling scientists to study the infection process and facilitate further research on treatments or prophylactics, including vaccines. While human challenge trials would offer a collective benefit to society, minimizing the risks is always difficult. Ethical controversy thus inevitably surrounds these trials. Typically, healthy young adults are recruited to serve as the first candidate subjects for human challenge trials because they are generally considered to represent a low-risk population. Here, we present three reasons for doubt about this healthy-young-adults-first criterion and give justification for also recruiting healthy older adults (or not-young adults), meaning those over 30 years of age, to participate in such trials for SARS-CoV-2.


Subject(s)
COVID-19/therapy , Clinical Trials as Topic/ethics , Patient Selection/ethics , Adult , Age Factors , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/mortality , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Clinical Trials as Topic/methods , Humans , SARS-CoV-2 , Young Adult
15.
J Empir Res Hum Res Ethics ; 16(3): 193-199, 2021 07.
Article in English | MEDLINE | ID: covidwho-1166860

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic, first reported in China, soon spread worldwide, has evolved into one of the most complex global public health crises the world has encountered in the last several decades. Conducting military medical research is vital to study the unique influences of military service conditions on soldiers' health and to improve the medical response in various emergency periods. The Israel Defense Forces (IDF) Medical Corps maintains an Institutional Review Board (IRB) which reviews clinical studies conducted within the IDF. During the COVID-19 pandemic, the IRB of the IDF had to rapidly implement procedural modifications in order to comply with expanding urgent demands for research without compromising ethical standards. The ethical dilemmas and the IDF policy and perspective are outlined in this article.


Subject(s)
COVID-19 , Clinical Trials as Topic/ethics , Military Health/ethics , Military Medicine/ethics , Pandemics , Adult , COVID-19/epidemiology , Humans , Israel/epidemiology , Military Personnel , SARS-CoV-2
16.
Lancet Glob Health ; 9(3): e366-e371, 2021 03.
Article in English | MEDLINE | ID: covidwho-1149597

ABSTRACT

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.


Subject(s)
COVID-19/drug therapy , Clinical Trials as Topic/standards , Patient Selection/ethics , Pregnancy Complications, Infectious/drug therapy , Clinical Trials as Topic/ethics , Eligibility Determination , Female , Humans , Pregnancy , SARS-CoV-2
19.
Ethics Hum Res ; 43(3): 42-44, 2021 May.
Article in English | MEDLINE | ID: covidwho-1135094

ABSTRACT

In the midst of the Covid-19 pandemic, ethicists, researchers, and journalists have recommended studies that deliberately infect healthy volunteers with the coronavirus as a scientific means of expediting vaccine development. In this essay, we trace the history of infection challenge experiments and reflect on the Nuremberg Code of 1947, issued in response to brutal human experiments conducted by Nazi investigators in concentration camps. We argue that the Code continues to offer valuable guidance for assessing the ethics of this controversial form of research, with respect particularly to the acceptable limits to research risks and the social value of research necessary to justify exposing human participants to these risks.


Subject(s)
COVID-19/therapy , Human Experimentation/ethics , SARS-CoV-2 , Clinical Trials as Topic/ethics , History, 20th Century , History, 21st Century , Human Experimentation/history , Humans , National Socialism/history
20.
Pediatr Res ; 90(5): 966-970, 2021 11.
Article in English | MEDLINE | ID: covidwho-1101635

ABSTRACT

As the nation implements SARS-CoV-2 vaccination in adults at an unprecedented scale, it is now essential to focus on the prospect of SARS-CoV-2 vaccinations in pediatric populations. To date, no children younger than 12 years have been enrolled in clinical trials. Key challenges and knowledge gaps that must be addressed include (1) rationale for vaccines in children, (2) possible effects of immune maturation during childhood, (3) ethical concerns, (4) unique needs of children with developmental disorders and chronic conditions, (5) health inequities, and (6) vaccine hesitancy. Because COVID-19 is minimally symptomatic in the vast majority of children, a higher acceptable risk threshold is required when evaluating pediatric clinical trials. Profound differences in innate and adaptive immunity during childhood and adolescence are known to affect vaccine responsiveness for a variety of childhood diseases. COVID-19 and the accompanying social disruption, such as the school shutdowns, has been disproportionately damaging to minority and low-income children. In this commentary, we briefly address each of these key issues, specify research gaps, and suggest a broader learning health system approach to accelerate testing and clinical trial development for an ethical and effective strategy to implement a pediatric SARS-CoV-2 vaccine as rapidly and safely as possible. IMPACT: As the US begins an unprecedented implementation of SARS-CoV-2 vaccination, substantial knowledge gaps have yet to be addressed regarding vaccinations in the pediatric population. Maturational changes in the immune system during childhood have influenced the effectiveness of pediatric vaccines for other diseases and conditions, and could affect SARS-CoV-2 vaccine responsiveness in children. Given that COVID-19 disease is far milder in the majority of children than in adults, the risk-benefit of a pediatric SARS-CoV-2 vaccine must be carefully weighed. The needs of children with developmental disabilities and with chronic disease must be addressed. Minority and low-income children have been disproportionately adversely affected by the COVID-19 pandemic; care must be taken to address issues of health equity regarding pediatric SARS-CoV-2 vaccine trials and allocation. Research and strategies to address general vaccine hesitancy in communities must be addressed in the context of pediatric SARS-CoV-2 vaccines.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Clinical Trials as Topic , Pediatrics , Research Design , SARS-CoV-2/pathogenicity , Vaccination , Age Factors , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/adverse effects , Clinical Trials as Topic/ethics , Host-Pathogen Interactions , Humans , Immunogenicity, Vaccine , Patient Safety , Pediatrics/ethics , Public Opinion , Risk Assessment , Risk Factors , SARS-CoV-2/immunology , Treatment Outcome , Vaccination/adverse effects
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