Meredith Karney, MS, MHA, Vice President for Health Economics, Center for Medical Interoperability

Patients Suffer Under Archaic Clinical Trial Interoperability Woes

“Most people's experience with healthcare is similar and it's frustrating,” says Meredith Karney, speaking from direct experience. As a 36-year-old with a history of Hodgkin’s lymphoma since 2002, she’s had an estimated 450 unique medical encounters, been part of several clinical trials, seen more than 20 primary and specialist physicians, interacted with more than 25 […]

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FDA Guidance Addresses ADHD Trial Nuances

A new U.S. Food and Drug Administration (FDA) guidance is designed to help practitioners conduct clinical trials that often feature relatively delicate young patient populations struggling with attention deficit hyperactivity disorder (ADHD) and related disorders. In general, central nervous system stimulant drugs demonstrate a strong concentration-response relationship for efficacy and safety, FDA said in

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Study Finds Lack of Training Restrains Technology Benefits

Clinical trial professionals are muddling through when it comes to grappling with technology day-to-day on the job, with about one-third of those responding to an in-depth survey saying the systems they use aren’t intuitive or easy to access, and only about one-third saying they feel adequately equipped with tools and training to do their job. […]

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FDA Offers Direction on Randomized Clinical Trials

A new draft guidance from the Food and Drug Administration (FDA) beefs up some of the recommendations in the International Council for Harmonization (ICH) E9 Statistical Principle for Clinical Trials and provides recommendations for the use of analysis of covariance (ANCOVA) in randomized clinical trials. The target population for a new drug or biologic usually […]