The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and sometimes decades — to evaluate, adopt and fully implement new technologies and methods.
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The University of North Carolina at Chapel Hill (UNC) School of Medicine’s innovative web-based solution to managing their trials’ startup processes was crowned the winner of this year’s Innovation Challenge at the 2023 MAGI East Clinical Research Conference in Philadelphia.
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The International Council on Harmonisation (ICH) has released the first two parts of a long-awaited third revision to ICH E6 – Good Clinical Practice and invited public comment on the draft that would replace and expand on the current GCP guideline, ICH E6(R2).
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One in five active phase 3 cancer trials changes its primary endpoints during the study but fewer than one-third of them report the modifications in publications, a new study published in JAMA Network Open found, adding another facet to industry concerns about trial transparency.
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The 2023 WCG MAGI East Clinical Research Conference held in Philadelphia last week brought together representatives of sites, sponsors, CROs and vendors to discuss key issues facing clinical trials. Here are just a few thoughts expressed by attendees and speakers at the conference.
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The FDA published three guidance documents for sponsors last week, providing advice on statistical analysis, endpoint selection and electronic data submission.
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