Viable Sponsor-CRO Partnerships Vital to Clinical Trial Success

With more than 13,000 employees in 40 countries, transparency and efficiency are critical to smooth operations at Covance, a contract research organization (CRO) that helped develop each of the top 50 drugs approved in 2014. Forging viable partnerships with sponsors is a vital piece of the puzzle, says Theresa Paster-Brown, MS, PMP, director for eTMF […]

NIH Logo

NIH Partners with Pharma to Boost Cancer-Related Clinical Trials

A new public-private partnership will facilitate systematic and uniform clinical testing of biomarkers to advance and understand the mechanisms of response and resistance to cancer therapy. The National Institutes of Health (NIH) and 11 leading biopharmaceutical companies just unveiled the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million, as part […]

Gerrit Hamre, Clinical Project Manager, Duke Clinical Research Institute

CTTI Recommendations Look to Lure ‘One and Done’ Investigators Back into the Fold

Nearly half of all so-called “one and done” principal investigators who retreat from clinical research after conducting a single study want back in if they can find resources and advice to help on their second attempt, according to findings from a new Clinical Trials Transformation Initiative (CTTI) survey and recommendations project. “We assumed when we […]

Protocol Scoring Can Bolster Patient Engagement Success Rates

It’s no secret that contract research organizations (CROs) struggle with patient recruitment. Some of the statistics, based on a 2013 survey by the Tufts Center for the Study of Drug Development, paint a daunting picture: The majority of studies eventually reach their recruitment goals (number of patients), although it may take a doubling of the […]

FDA Logo

FDA Awards Grants to Stimulate Rare Diseases Trial Development

The Food and Drug Administration (FDA) just doled out $22 million over the next four years in the form of 15 new clinical trial research grants designed to spur development of new produces for patients with rare diseases. “Given the often small number of patients facing certain rare diseases, there can be limited resources devoted […]