International The International Council for Harmonization (ICH) are preparing new guidelines for analytical methods used by manufacturers for testing medicines post approval. According to the feedback from ICH the purpose…
Continue readingEurope EMA has released a new initiative called ‘Accelerating Clinical Trials in the EU (ACT EU)’. According to the paper it will adapt some of the methods used in COVID…
Continue readingUSA A study looking into RWD from 50 post-approval confirmatory studies requested by FDA shows that data is inconclusive and difficult to analyse. The authors mentioned that some of the…
Continue readingUSA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingFDA extended access program started back in 2009 and it allowed patients with life-threatening diseases who have exhausted all other options to try experimental drugs, which are not on the…
Continue readingIt is generally accepted that people with intellectual disabilities are not considered in clinical research if the type of the disease could be studied with people without disabilities. The reasons…
Continue readingIf you are working with hospitals based in Europe or you are team member of a clinical trials team in a European hospital you are probably already aware of the…
Continue readingIn October 2015 FDA released a clarification regarding IND application requirements. Their clarification is regarding queries and confusions amongst sponsors, investigators and RECs when do they need to apply for…
Continue readingEuropean Medicine Agency has started reviewing the GCP guide with the idea to adopt it to the changes in the modern world, including new technologies, changes in business models, new…
Continue readingApple ResearchKit attracted a lot of attention from researchers after its announcement on 9th of March 2015. One of the most discussed topics is clinical trials recruitment and consent option and…
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