1,720,961 research outputs found
The FDA's Proposal for Public Disclosure of Adverse Events in Gene Therapy Trials
No full textIn January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.</jats:p
Data Safety Monitoring during Covid‐19: Keep On Keeping On
No full textThis article discusses data safety monitoring during Covid‐19. the pandemic of Covid‐19 has created the imperative for new treatments and a vaccine, countless clinical trials already in progress have still needed oversight. With the emergence of Covid-19, studies needed to quickly adapt because what it meant to protect study participants wasn’t the same as it had been weeks earlier. One of the primary roles of DSMBs is to evaluate interim data to ensure that participants aren’t at additional risk by virtue of being randomized to a study arm found to have more risks or fewer benefits than other arms. Stopping a study early when it falls out of equipoise is the most monumental task a data safety monitoring boards (DSMB) is charged to perform. The pandemic brought with it risks that changed many studies’ risk-benefit calculus. In some cases, merely attending a visit to report symptoms, check progress, verify pill counts, or report adverse events posed additional risk. Participants in placebo arms are typically expected to experience little benefit, and certainly not greater harm, than participants in the active therapy group. Suddenly, participating in even the most innocuous placebo arm might result in unforeseen harm. DSMBs’ primary responsibility is to protect research participants, but if data is compromised, then the benefit of the study will never outweigh the risks to participants. Thus, protecting the integrity of data collection was also foremost in the minds of DSMB members. Researchers, representatives from the National Institutes of Health, and DSMB members were in constant communication about trials already in progress.</p
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
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