Regulations

The Past, Present and Future of Public Clinical Trial Registries

In my article on the 3 main limitations to public clinical trial registries, I mentioned that public registries were not designed for the purposes of feasibility. While this is true, the scientific community was intended as one of the beneficiaries of the initiative right from the start.  To understand better why public registries hold back …

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Guidance on the Management of Clinical Trials during COVID-19: How Countries respond

2020 began with a surprise for many people, industries and governments. The coronavirus outbreak turned the world upside down and became a global threat the likes of which we hadn’t experienced for ages. Unfortunately, the clinical research industry was also impacted severely mostly due to the social distancing measures recommended by national and global organisations …

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National Guidances for Conducting Clinical Trials During the COVID-19 Pandemic

FDA, EMA and many national drug agencies have issued national recommendations and guidelines for ongoing clinical trials. They are focusing on providing support for patients, sites and investigators during the COVID-19 pandemic. Many of these guidelines suggest avoiding sites visits whenever possible as well as advice for remote monitoring visits. USA, FDA Coronavirus (COVID-19) Update: …

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