Researchers reeling as UK votes to leave EU – Nature
Alison Abbott & Daniel Cressey from the science journal, Nature, wrote a thoughtful piece focusing on the fallout of Brexit from an industry viewpoint.
"It was a result," Abbot and Cressey write, "that most scientists didn’t want."
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With the UK voting to leave the EU, question marks have been raised about the future of the UK’s participation in research programmes across Europe. Throw into the mix the employment status of many European scientists has now been shrouded in doubt, there is a large degree of uncertainty facing the UK’s status in clinical research.
Read more to learn how scientists reacted to the Brexit vote
Inovio Pharmaceuticals and GeneOne Life Science Receive Approval for First-in-Man Zika Vaccine Clinical Trial – Value Walk
Value Walk reports that Inovio Pharmaceuticals and GeneOne Life Science are to begin a phase I human clinical trial evaluating Inovio’s Zika DNA vaccine (GLS-5700). The announcement comes on the back of positive preclinical tests where the synthetic vaccine was found to induce robust antibody and T cell responses in animals. Experts say these results showcase the vaccine’s potential to prevent infection in humans.
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By GlobalDataIt is believed the phase I open-label, dose ranging study will involve 40 healthy participants, assessing the safety and immunogenicity of GLS-5700, which will be administered intradermally with Inovio’s CELLECTRA®.
Click here to read more about the latest development in the fight against the Zika virus.
FDA Releases Draft Guidance on Demographic Data in Clinical Trials – Med Device Online
Jof Enriquez from Med Device Online writes the US FDA has issued draft guidance how trial sponsors should report age, race and ethnicity in medical device clinical trials, adding the step should "reflect representative proportions of intended use populations."
This comes after the FDA sought insight from experts and stakeholders through public forums to help establish the draft guidance. Upon receiving recommendations, the FDA issued its signature document titled, Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.
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Mount Sinai Seeks to Speed Clinical Trials Recruitment – Healthcare Informatics
Healthcare Informatics reports Mount Sinai Health System has put in effect a programme that helps boost patient recruitment.
In an effort to simplify pre-screening processes, Mount Sinai will adopt the Clinithink Ltd.’s CLiX Enrich for Clinical Trials solution that enables investigators "to process large volumes of progress notes and reports from electronic health records to flag patients whose clinical documentation indicates they closely match a trial’s inclusion/exclusion criteria."
This helps coordinate a shortlist of eligible participants allowing investigators to select patients more efficiently.
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First CRISPR clinical trial gets green light from US panel – Nature
Sarah Reardon of Nature writes that CRISPR, a genome-editing technology, is tantalisingly close to its first use in clinical trials.
An advisory panel from the US National Institutes of Health (NIH) gave the green light on June 21st to a proposal to use CRISPR-Cas9, which helps "augment cancer therapies that rely on enlisting a patient’s T cells, a type of immune cell."
Experts say that gene editing has the potential to enhance similar treatments helping to eliminate "some of their vulnerabilities to cancer and the body’s immune system".
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