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Coronavirus disease 2019 (COVID-19) has sickened millions, killed hundreds of thousands, and utterly disrupted the daily lives of billions of people around the world. In an effort to ameliorate this devastation, the biomedical research complex has allocated billions of dollars and scientists have initiated hundreds of clinical trials in an expedited effort to understand, prevent, and treat this disease. National emergencies can stimulate significant investment of financial, physical, and intellectual resources that catalyze impressive scientific accomplishments, as evident with the Manhattan Project, penicillin, and the polio vaccines in the 20th century. However, pressurized research has also led to false promises, disastrous consequences, and breaches in ethics. Antiserum in the 1918 flu epidemic, contaminated yellow fever vaccines in World War II, and unethical human experimentation with mustard gas offer just a few cautionary exemplars. It is critical to continue biomedical research efforts to address this pandemic, and it is appropriate that they receive priority in both attention and funding. But history also demonstrates the importance of treating early results—such as those associated with hydroxychloroquine—with caution as we only begin to understand the biology, epidemiology, and potential target points of COVID-19.

Age- and Weight-Adapted Dose of Prasugrel Versus Standard Dose of Ticagrelor in Patients With Acute Coronary Syndromes: Results From a Randomized Trial: Annals of Internal Medicine: Vol 173, No 6

Background: The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown. Objective: To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800) Design: Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial. Setting: 23 centers in Germany and Italy. Patients: 3997 patients with ACS planned for invasive management. Intervention: Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group). Measurements: The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months. Results: In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88]; P for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2). Limitation: The study is a subgroup analysis. Conclusion: In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding. Primary Funding Source: German Center for Cardiovascular Research and Deutsches Herzzentrum München.

COVID-19: The Worst Days of Our Careers

Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research

Evaluating the quality and effectiveness of the institutional review boards (IRBs) responsible for overseeing research involving human participants is critically important but perpetually challenging. Seemingly common-sense measures, such as the number of proposals approved with and without major modifications and the number of unexpected adverse events occurring in approved protocols, can be misleading indicators of participant protection, and regulatory compliance may not correspond to achieving ethical goals. These measurement challenges make it difficult to assess the validity of concerns about different IRB models. A group of U.S. senators recently raised questions about the increasing use of for-profit IRBs to review research proposals (as opposed to boards typically housed at academic medical centers and health care institutions) and, more specifically, about the growing trend of private equity ownership and consolidation of for-profit IRBs. Although all IRBs face pressure to speed reviews and none are entirely free of conflicts of interest, the private equity model is particularly susceptible to approaches that could undercut the ethical mission of IRBs to protect and promote the rights and welfare of research participants. Ideally, the quality of board oversight could be measured directly, rather than relying on the heuristic of board type; this article describes several current efforts toward this goal. In the meantime, one improvement may be to pursue a new model of IRB oversight: independent nonprofit boards that stand apart from research institutions, take advantage of business approaches to research review, and minimize conflicts of interest.

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