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The big question in the clinical research world is how things will look when the COVID-19 pandemic has ended. Will everything go back to the way it was? If not, what changes will remain?
The Food and Drug Administration’s guidance on conducting clinical trials during the pandemic provides reassurance that IRBs and research organizations can employ flexibility as they make changes to accommodate a world in which many patient visits are conducted remotely. The guidance does not change or modify existing regulations, but synthesizes existing regulations and emphasizes the built-in flexibility.
Research organizations and IRBs continue to face challenges and make tough decisions based on the best available information about a pandemic that changes daily as it spreads across the world.
Dozens of potential treatments for COVID-19 are under investigation: existing antiretrovirals, anti-malaria drugs, monoclonal antibodies, and Chinese traditional medicines among them. Additionally, companies are rapidly developing new drugs. But poorly designed studies subject patients to the risks of adverse events without learning if the intervention works.
Innovative neuroscience research is vital, but individuals with mental illness pose some unique ethical concerns in terms of their participation. The results of a recent study provided some reassurance on the decision-making processes of individuals.
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Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, Physician Editor Lindsay McNair, MD, MPH, MSB, and Nurse Planner Amy Johnson, MSN, RN, CPN report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.
