The FDA approved Alzheimer’s disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don’t yet have.
It was first officially described 115 years ago, but we still do not have a cure for Alzheimer’s disease. The human brain is extremely complex, and Alzheimer’s is its most complex disease.
With COVID-19 vaccine announcements making headlines, non-scientists need to know what clinical trial results mean. Here are some key points to look for in vaccine trial reports.
COVID-19 vaccines are at risk of being undermined by vaccine hesitancy. Pharma must take steps to ensure transparency in data monitoring committees and trial data to build public trust in vaccines.
Asking these four questions can help us identify good news when we see it, be more critical of news reports, or delay our judgement until we have more information.
Any COVID-19 vaccine is likely to be given first to higher risk groups before it is given to children. But we still need vaccines that are safe and effective for them too.
Pregnant women are at increased risk for serious COVID-19 complications and should be a high-priority group for vaccination. Excluding them from vaccine trials puts them and their offspring at risk.
There are many scientific and ethical challenges ahead. But these types of trials have helped in the development of vaccines against a few diseases. Could they do the same for COVID-19?
Will a vaccine for COVID-19 be safe? Animal testing, human clinical trials and post-approval surveillance give us good grounds to believe that a future approved vaccine will work and be safe.
Professor of Bioethics & Medicine, Sydney Health Ethics, Haematologist/BMT Physician, Royal North Shore Hospital and Director, Praxis Australia, University of Sydney