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Apple plans to launch a massive clinical trial for the Apple Watch’s ability to detect a heart condition that kills 130,000 individuals every year. Read More
An Alzheimer’s research group offers positive news on clinical trials for Alzheimer’s drugs as well as suggestions for the way forward, in a new report. Read More
Because of delays in implementing the EU regulation, the UK’s compliance with future EU clinical trials rules will likely be subject to negotiation, as the country plans to only immediately implement EU regulations that were in place ahead of the planned March 2019 exit from the EU, according to a UK government official. Read More
New medical device clinical trial guidance aims to improve participation diversity and increase data consistency and transparency, FDA officials said in an Oct. 31 webinar. Read More
Angela J. Bowen, a medical research pioneer, philanthropist and founder of Western Institutional Review Board, which grew to become the world’s largest independent review board, died at her home in Olympia, Washington on Aug. 31. Read More
The FDA issued a warning letter to a Texas clinical researcher, claiming he deviated from his own investigational plan by enrolling ineligible trial subjects. Read More
The FDA’s rules for clinical investigators cover a lot of ground, from how to avoid financial conflicts of interest, to delegating investigator authority to other members of the trial team, to hiring—and sometimes firing—investigators under your charge. The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but even those documents can’t answer every question you may have about the people who actually conduct the trial. Read More