A review of clinical efficacy data supporting emergency use authorization for COVID-19 therapeutics and lessons for future pandemics.

Emergency Use Authorization (EUA) allows the US Food and Drug Administration (FDA) to expedite the availability of therapeutics in the context of a public health emergency. To date, an evidentiary standard for clinical efficacy to support an EUA has not yet been established. This review examines the clinical data submitted in support of EUA for antiviral and anti-inflammatory therapeutics for coronavirus disease 2019 (COVID-19) through December of 2021 and the resilience of the authorization as new clinical data arose subsequent to the authorization. In the vast majority of cases, EUA was supported by at least one well-powered randomized controlled trial (RCT) where statistically significant efficacy was demonstrated. This included branded medications already approved for use outside of the context of COVID-19. When used, the standard of a single RCT seemed to provide adequate evidence of clinical efficacy, such that subsequent clinical studies generally supported or expanded the EUA of the therapeutic in question. The lone generic agent that was granted EUA (chloroquine/hydroxychloroquine) was not supported by a well-controlled RCT, and the EUA was withdrawn within 3 months time. This highlighted not only the ambiguity of the EUA standard, but also the need to provide avenues through which high quality clinical evidence for the efficacy of a generic medication could be obtained. Therefore, maintaining the clinical trial networks assembled during the COVID-19 pandemic could be a critical component of our preparation for future pandemics. Consideration could also be given to establishing a single successful RCT as regulatory guidance for obtaining an EUA.

Assessing the Use of Wing Morphometrics to Identify Fall Armyworm (Lepidoptera: Noctuidae) Host Strains in Field Collections.

The fall armyworm (Spodoptera frugiperda) (J. E. Smith) (Lepidoptera: Noctuidae), a major agricultural pest in the Western Hemisphere, has recently become established in Africa and Asia. This highly polyphagous species has potential to economically harm multiple crops. Contributing to this host range are two fall armyworm populations historically called 'host strains' that differ in host specificity. Understanding behaviors of the two strains is crucial to effective management of this pest. A major difficulty in such studies is that strains have long been considered morphologically indistinguishable, with molecular markers the only reliable means of identification. However, studies of fall armyworm in Colombia reported strain differences in wing morphology sufficiently large to potentially provide a more economical alternative method to determine strain. This study tested whether a similar phenotypic difference was present in Florida populations using geometric morphometric analysis of 15 anatomical landmarks on forewings of 182 specimens from three habitats associated with different host plants. Principle component and linear discriminant analyses identified significant differences in wing size and shape in comparison of strains from different habitats, but not between strains within the same habitat. Data indicate that apparent strain distinctions in wing phenotype are most likely a secondary consequence of differences in developmental growth patterns on different host plants combined with strain-biased host choice. Furthermore, Florida specimens showed much larger phenotypic overlap than observed for strains from Colombia. Together these findings suggest that wing morphology is probably not a reliable indicator of strain identity in field populations where different host plants are available.

Peer assisted feedback: a successful approach for providing feedback on United States Medical Licensing Exam-style clinical skills exam notes in the United States.

PURPOSE: Peer assisted learning (PAL) promotes the development of communication, facilitates improvement of clinical skills, and provides feedback to learners. We utilized PAL as a conceptual framework to explore the feasibility of peer-assisted feedback (PAF) to improve note writing skills without requiring faculty time. The aim was to assess if peer assisted learning was a successful method to provide feedback on USMLE-style clinical skills exam notes by using student feedback on a survey in the United States. METHODS: The University of Florida College of Medicine administers clinical skills examinations (CSEs) includes USMLE-like note-writing. PAL, where students support the learning of peers, was utilized as an alternative to faculty feedback. Second (MS2) and third (MS3) year medical students taking CSEs participated in faculty-run note-grading sessions immediately after testing, which included explanations of grading rubrics and the feedback process. Students graded an anonymized peer's notes. The graded material was then forwarded anonymously to its student author to review. Students were surveyed on perceived ability to provide feedback and benefits derived from PAF using a Likert scale (1-6) and open-ended comments during the 2017-2018 academic year. RESULTS: Students felt generally positively about the activity with mean score for items related to educational value of 4.49 for MS2 and 5.11 for MS3 out of 6. MS3s perceived peer feedback as constructive, felt benefit from evaluating other's notes, and felt the exercise would improve their future notes. While still positive, MS2 students gave comparatively lower scores than the MS2 students. CONCLUSION: PAF was a successful method to provide feedback on student CSE notes, especially for MS3s. MS2s commented that although they learned during the process, they might be more invested in improving their note writing as they approach their own USMLE exam.