Paul Glimcher, CEO, Data Cubed

Gaming Technology Promises Improved Patient Recruitment, Retention

According to the “State of Online Gaming 2018” market research report, 32% of video game enthusiast respondents to an international survey said they would quit their job if they could support themselves as professional video gamers. While no one is expecting gamers to line up in droves to “play” in clinical trials, per se, some […]

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NIH ‘All of Us’ Program Funds Three New Genome Centers

The National Institutes of Health’s (NIH’s) All of Us Research Program has awarded $28.6 million to establish three genome centers around the country. These centers will begin to generate genomic data from biosamples contributed by program participants. Ultimately, this information will become a critical component in the program’s precision medicine research platform, a national resource […]

FDA Commissioner Scott Gottlieb, MD

FDA Continues Proactive Clinical Trial Guidance Rollout

President Donald Trump, an avowed promoter of limited government, might be a bit surprised by the activities of U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD. Leading a seemingly reinvigorated FDA, Gottlieb’s agency continues to issue proactive guidances at an impressive pace. To be sure, not every guidance expands federal oversight, yet most […]

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FDA Guidance Clarifies Some Human Subjects Protection Expectations

A new guidance from the U.S. Food and Drug Administration (FDA) provides welcome direction to sponsors, investigators, and institutional review boards (IRBs) on issues including human subjects protection. The guidance is one of the agency’s follow-ups to its revisions of the “Common Rule” (Federal Policy for the Protection of Human Research Subjects), published January 2017 […]

Rashieda Gluck, Senior Vice President for Global Clinical Operations, Aurinia Pharmaceuticals

To Attract the Best Study Sites, Treat Them Like ‘Real’ Partners

Sponsors and contract research organizations (CROs) hoping to retain high-quality sites for their important clinical trials should treat site personnel like partners by supporting them throughout the lifecycle of the studies, says Rashieda Gluck, senior vice president for global clinical operations at Aurinia Pharmaceuticals, a 40-employee shop that works across more than 200 clinical trial […]