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The CenterWatch Weekly, August 15, 2016

Monday, August 15, 2016

Principal investigator charged for insider trading

It’s rare for a principal investigator (PI) to face insider trading charges based on confidential developments in a clinical trial. But earlier this month, Edward J. Kosinski, M.D., a PI and president of Connecticut Clinical Research, was indicted on two counts of securities fraud by a federal grand jury in Connecticut for allegedly trading shares of Regado Biosciences in 2014 after receiving non-public information about the clinical trial from the project manager. The case has attracted interest from the me­dia in the wake of other recent high-profile secu­rities fraud episodes involving those associated with the pharmaceutical industry. For the clinical research community, the Kosinski case also calls attention to a related issue concerning how an investigator’s financial interest—payments, stock in the sponsor company or a proprietary interest in the product—is handled, from how the information should be disclosed to its the potential impact on the conduct of clinical trials.

 

Industry concerned over unfinished and unreported pediatric trials

A newly published study has under­scored concerns in the industry about the number of pediatric trials that go unfinished and unreported. In an article in the August issue of Pediat­rics, coauthors Natalie Pica, M.D., Ph.D., and Florence Bourgeois, M.D., MPH, of Boston Children’s Hospital and Harvard Medical School, found that of 559 randomized clinical pediatric trials, 104 (19%) were discontinued early—and of 455 completed trials, 136 (30%) were not published.

 

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