Weekly Features

Principal investigator charged for insider trading

Monday, August 15, 2016

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.

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GSK and Verily’s Galvani Bioelectronics forges ahead, ushering in a new era of medicine

Monday, August 8, 2016

Galvani Bioelectronics, a newly established company launched by GlaxoSmithKline (GSK) and Verily Life Sciences (formerly Google Life Sciences), will explore a new wave of science. Galvani Bioelectronics will focus on the development of bioelectronic medicine: the use of implantable devices to modify the electrical signals that nerve cells use to communicate within the body.

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EMA proposes changes to first-in-human trials spurred by January’s Bial trial deaths

Monday, August 1, 2016

Are the risks faced by phase I clinical trial participants too great? The European Medicines Agency (EMA), the European Commission and the Member States of the European Union (EU) believe so. Together, they’re proposing changes to current guidance on first-in-human clinical trials that would, if successful, improve strategies for identifying and mitigating risks to study subjects.

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Enrollment strategies in the PMI Cohort Study will bolster diversity in clinical research industry-wide

Monday, July 25, 2016

The Precision Medicine Initiative (PMI) Cohort Program is an ambitious observational study backed by the National Institutes of Health (NIH) that seeks to enroll at least one million Americans by 2020. Because of its massive scale, the Cohort Program is often compared to the 1948 Framingham Heart Study. Yet a crucial differentiator is that the Cohort Program aims to recruit participants with diverse backgrounds and ethnicities to better understand the root cause of disease for all Americans.

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ePRO poised to get more user friendly as eClinicalHealth develops validation for BYOD

Monday, July 25, 2016

Sponsors and CROs are enthusiastic about the usefulness of handheld devices in clinical trials, which allow study subjects to input information in real time, rather than having all patient info stuffed into the patient’s meeting at the study site. Naturally, many companies are now in a race to make electronic patient-reported outcomes (ePRO) more user friendly. eClinicalHealth of Stirling, Scotland, has just pulled ahead.

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