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news roundup
According to a new study from the Tufts Center for the Study of Drug Development, efforts to improve recruitment and retention appear to be paying off. Enrollment timelines now are equal to or shorter than planned timelines in 77% of studies, down from the last survey 2012.
Stand Up To Cancer (SU2C) announced an initiative to increase minority representation in cancer clinical trials by requiring its supported research grant proposals to include recruitment and retention of patients from ethnic groups to improve diverse participation in cancer clinical trials.
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Three Key Critical Considerations Before Embarking on Decentralized Trials
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Signant Health announced new audit trail reviewing and reporting capabilities for its electronic clinical outcome assessment (eCOA) and remote sensor platform, TrialMax. These latest features include standardized key performance indicators (KPIs) on data updates, removals and original entries data visualization dashboards; detailed audit trail access for user accounts, roles and login activity in Signant Health’s study portal, among others.
Articles
In this article, the authors discuss new regulations issued out of Clinical Trial Regulation (EU) 536/2014 that will impact labeling. Changes such as the inclusion of “period of use” dates on both immediate and outer packaging, removing the option for companies to reference the information centrally via interactive response technology (IRT) or randomization and trial supply management (RTSM) systems, seems straightforward, but in cases around investigational medicinal product (IMP) stability dates is much more problematic.
Columnist Peter O’Donnell reports the EU’s fight against superbugs, especially bacteria that have become resistant to antibiotics, “has brought little progress to date,” according to a European Court of Auditors report.
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AI in Action: Clinical Development AI Use Cases
Access an online resource with useful tools and practical information about advances in RBM. The site provides useful white papers, articles, webcasts, and more.
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Blog Posts
In this Q&A, Karmen Trzupek, Director of Clinical Trial Services at InformedDNA, discusses challenges around identifying patients that would be good candidates for gene therapies.
The EMA has delivered ‘10 recommendations to unlock the potential of big data for public health in the European Union’, a document drafted by the task force on big data that it shares with the complementary Heads of Medicines Agencies. Top of its list is a platform that would access and analyze healthcare data from across the EU, creating a European network of databases that can support regulatory decision-making with robust evidence from healthcare practice.
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