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Experience levels of principal investigators fluctuate wildly the world over, a fact that could put promising research at risk, according to a Tufts University report on protocol noncompliance rates and principal investigator turnover. Read More
An industry panel agreed Jan. 29 that industry stakeholders need to agree on a set of standards that should be part and parcel of investigators’ good clinical practice training. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country. Read More
China’s medical device authority released a draft regulation outlining how it will accredit medical institutions that conduct clinical trials for devices. Read More
Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products.
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Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
The House Energy & Commerce Committee, which oversees the FDA, is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight and give industry incentives to find new uses for old drugs. Read More
Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015. Read More
Mobile health programs can unburden clinical trial sponsors and investigators by streamlining procedures, eliminating unnecessary activities and reducing site visits, according to GlaxoSmithKline and Medidata. Read More