Articles Tagged With:
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Elagolix, Estradiol, and Norethindrone Acetate Capsules (Oriahnn)
Elagolix-EN should be prescribed to manage heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
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Cloth Masks — Just for Looks?
How effective are homemade fabric masks many are using to protect others from COVID-19 transmission?
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MUCH Ado About WUCH
In a long-term, fixed-drug therapy of hypertension study, masked uncontrolled and white coat uncontrolled hypertension exhibited poor reproducibility over four years.
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Early Data on Remdesivir for Severe COVID-19: A Promising Start?
In this group of patients hospitalized with severe COVID-19, most of whom required invasive ventilation, 68% showed clinical improvement after treatment with remdesivir on a compassionate-use basis.
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Two Possible Mechanisms of Disease in COVID-19
COVID-19 infection may be associated with an increased risk of blood clotting and related thrombotic events, but there are insufficient data to support indiscriminately discontinuing medications that play a critical role in the management of chronic cardiovascular disease.
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Biometrics Expert Discusses Data Integrity for COVID-19 Clinical Trials
The first remdesivir double-blind, placebo-controlled clinical trial for treating COVID-19 was published recently in Lancet. A member of the trial’s data safety monitoring board is Weichung Shih, PhD. Shih discussed the role of biostatisticians in protecting data integrity for clinical trials and the challenges during the COVID-19 pandemic.
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Enhance Health Literacy Among Study Participants
IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent forms. IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
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IRB Highlights Standardized and Effective Metrics Model
As IRBs and research programs increasingly seek IRBs of record and form reliance agreements, they will need to know whom to trust. IRBs also need their own performance data to share with sponsors, researchers, and others. The challenge is developing metrics that work and can be used by other IRBs for benchmarking purposes.
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Court Rejects Challenge to Federal Price Transparency Rule
Plaintiffs announced intention to appeal decision.
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Small IRB Copes with COVID-19 Pandemic Under Limited Budget
Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.