COVID-19 should come as a prompt to the clinical research sector to rapidly reinvent itself as it works to design and launch clinical trials for vaccine and therapeutic candidates “in the teeth of the epidemic,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. Read More
Ireland’s Health Products Regulatory Authority (HPRA), Department of Health, National Office for Research Ethics Committees and Health Research Declaration Committee have agreed on an expedited review process for human trials related to COVID-19. Read More
Pharma companies and CROs continue to announce temporary suspensions of patient recruitment during the COVID-19 pandemic, but some companies are pivoting themselves and re-positioning their efforts toward studying possible treatments for the virus: Read More
To get COVID-19 vaccine and therapeutics candidates through the pipeline faster, FDA Commissioner Stephen Hahn said yesterday that the agency is interested in developing master protocols, possibly in conjunction with regulatory agencies in other countries. Read More
Sponsors that choose to conduct remote trial monitoring during the COVID-19 crisis should focus on the most critical site documentation and source data and ensure the security of the data by creating a secure electronic viewing portal or using a sponsor-controlled electronic system or cloud-based repository, says an updated guidance the FDA released last week. Read More
Sixteen drugmakers have signed on for a major initiative by the National Institutes of Health to speed the development of COVID-19 therapies and vaccines. Read More
As the COVID-19 pandemic pushes sponsors toward conducting remote outcome measures, it’s important for them to ensure that data they gather and the conclusions drawn from them are still valid and reliable. Read More
The impact of COVID-19 on the clinical trials industry will be far-reaching and many of the changes sponsors and sites are making to deal with the coronavirus outbreak will continue to be adopted long after the pandemic is under control. Read More
Global research charity Wellcome Trust is asking CEOs of multinational companies to help raise at least $8 billion by the end of the month to cover a worldwide “funding shortfall” for developing and manufacturing COVID-19 vaccines, treatments and diagnostics. Read More
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