The National Institute of Allergy and Infectious Diseases Decision to Stop the Adaptive COVID-19 Trial: On Solid Ethical and Scientific Grounds.
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ABSTRACT:
SUBMITTER: Mozersky J
PROVIDER: S-EPMC7250548 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:A priority for the National Institute of Allergy and Infectious Diseases is development of a universal influenza vaccine providing durable protection against multiple influenza strains. NIAID will use this strategic plan as a foundation for future investments in influenza research.
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Project description:Survival of junior scientists in academic biomedical research is difficult in today's highly competitive funding climate. National Institute of Health (NIH) data on first-time R01 grantees indicate the rate at which early investigators drop out from a NIH-supported research career is most rapid 4 to 5 years from the first R01 award. The factors associated with a high risk of dropping out, and whether these factors impact all junior investigators equally, are unclear. We identified a cohort of 1,496 investigators who received their first R01-equivalent (R01-e) awards from the National Institute of Allergy and Infectious Diseases between 2003 and 2010, and studied all their subsequent NIH grant applications through 2016. Ultimately, 57% of the cohort were successful in obtaining new R01-e funding, despite highly competitive conditions. Among those investigators who failed to compete successfully for new funding (43%), the average time to dropping out was 5 years. Investigators who successfully obtained new grants showed remarkable within-person consistency across multiple grant submission behaviors, including submitting more applications per year, more renewal applications, and more applications to multiple NIH Institutes. Funded investigators appeared to have two advantages over their unfunded peers at the outset: they had better scores on their first R01-e grants and they demonstrated an early ability to write applications that would be scored, not triaged. The cohort rapidly segregated into two very different groups on the basis of PI consistency in the quality and frequency of applications submitted after their first R01-e award. Lastly, we identified a number of specific demographic factors, intitutional characteristics, and grant submission behaviors that were associated with successful outcomes, and assessed their predictive value and relative importance for the likelihood of obtaining additional NIH funding.
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Project description:BackgroundThe Ramazzini Institute (RI) has completed nearly 400 cancer bioassays on > 200 compounds. The European Food Safety Authority (EFSA) and others have suggested that study design and protocol differences between the RI and other laboratories by may contribute to controversy regarding cancer hazard findings, principally findings on lymphoma/leukemia diagnoses.ObjectiveWe aimed to evaluate RI study design, protocol differences, and accuracy of tumor diagnoses for their impact on carcinogenic hazard characterization.MethodsWe analyzed the findings from a recent Pathology Working Group (PWG) review of RI procedures and tumor diagnoses, evaluated consistency of RI and other laboratory findings for chemicals identified by the RI as positive for lymphoma/leukemia, and examined evidence for a number of other issues raised regarding RI bioassays. The RI cancer bioassay design and protocols were evaluated in the context of relevant risk assessment guidance from international authorities.DiscussionAlthough the PWG identified close agreement with RI diagnoses for most tumor types, it did not find close agreement for lymphoma/leukemia of the respiratory tract or for neoplasms of the inner ear and cranium. Here we discuss a) the implications of the PWG findings, particularly lymphoma diagnostic issues; b) differences between RI studies and those from other laboratories that are relevant to evaluating RI cancer bioassays; and c) future work that may help resolve some concerns.ConclusionsWe concluded that a) issues related to respiratory tract infections have complicated diagnoses at that site (i.e., lymphoma/leukemia), as well as for neoplasms of the inner ear and cranium, and b) there is consistency and value in RI studies for identification of other chemical-related neoplasia.
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Project description:Evidence from well-designed clinical trials may guide clinicians, reduce regional variation, and lead to improved outcomes. Many physicians choose to ignore evidence-based practice guidelines. Using unproven therapies outside of a randomized trial slows recruitment in clinical trials that could yield information on clinical and economic efficacy. Using acute stroke therapy as an illustration, we present an ethical hierarchy for therapeutic decision making during medical emergencies. First, physicians should offer standard care. If no standard care option exists, the physician should consider enrollment in a randomized clinical trial. If no trial is appropriate, the physician should consider a nonrandomized registry, or consensus-based guidelines. Finally, only after considering the first 3 options, the physician should use best judgment based on previous personal experience and any published case series or anecdotes. Given the paucity of quality randomized clinical trial data for most medical decisions, the "best judgment" option will be used most frequently. Nevertheless, such a hierarchy is needed because of the limited time during medical emergencies for consideration of general principles of clinical decision making. There should be general agreement in advance as to the hierarchy to follow in selecting treatment for critically ill patients. Were more clinicians to follow this hierarchy, and choose to participate in clinical trials, the generation of new knowledge would accelerate, yielding rigorous data supporting or refuting the efficacy and safety of new interventions more quickly, thus benefiting far more patients over time.
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Project description:The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.
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Project description: Not available
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Project description:Substandard drugs are a major public health issue worldwide. Key person such as the Qualified Person in China and Europe is responsible for rejecting substandard drugs during the manufacturing stage. This study applies the Hunt-Vitell ethical decision-making model to study their rejection intentions on substandard drugs. Using the experimental vignette methodology, two scenarios were developed to represent different levels of deviation from regulations in pharmaceutical manufacturing. Responses from 204 Chinese key persons show a decline in deontology, ethical judgment, and rejection intention, and an increase in teleology in the minor deviation scenario, in comparison with the major deviation scenario. The results from the two scenarios show that the Hunt-Vitell ethical decision-making model is well fitted to explain substandard drug rejection intentions. Organizational and occupational commitments have a significant positive impact on deontological evaluation. Whereas, occupational commitments have a significant negative impact on teleological evaluation. This study suggests that strengthening occupational commitment can significantly affect key person's rejection intentions of substandard drugs.
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Project description:BackgroundEthical decision-making confidence develops from clinical expertise and is a core competency for nurse leaders. No tool exists to measure confidence levels in nurse leaders based upon an ethical decision-making framework.AimsThe objective of this research was to compare ethical decision-making among nurse leaders in the U.S. and three German-speaking countries in Europe by developing and testing a newly constructed Ethical Decision-Making Confidence (EDMC) scale.MethodsThe cross-sectional survey included 18 theory-derived questions on ethical decision-making confidence which were used to develop the scale.ParticipantsA convenience sample of nurse leaders from the U.S. and three German-speaking countries in Europe who self-identified as holding a leadership position.Ethical considerationsEthical approval was given by the IRB Board of a U.S. university. Participation in the survey implied voluntary consent.ResultsThe scale's item structure dimensionality and subscale's reliability were analyzed and compared between nurse leaders from all four countries. A principal component analysis (PCA) produced a 15-item bi-dimensional EDMC scale yielding a skill-related (9-item) and a behavior-related (6-item) confidence dimension. EDMC subscales showed good-to-excellent internal consistency. In both subscales, U.S. nurse leaders rated their mean EDMC score higher than their German-speaking counterparts in Europe.DiscussionThis exploratory study is the first of its kind to focus on nurse leaders' confidence regarding ethical decision-making in an international context. An overarching factor structure was identified, which is shared by the two samples of nurse leaders and to examine (sub)scales' psychometric properties.ConclusionThis newly developed scale is an effective tool for measuring ethical decision-making confidence in nurse leaders. The promising results of this study should be replicated to ensure validity and reliability of the EDMC scale measuring skill-related and behavior-related concepts and include nurse leaders from various cultural, social, and demographic groups.
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