Applied Clinical Trials June 2016

June 2016 | Volume 25, Issue 6
News
FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.
European forum tackles the problem of limited elderly patients involved in clinical trials.
Survey reveals mixed adoption of paperless data collection in clinical trials, pointing to the need for greater alignment of new eClinical technologies and study conduct.
Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations—and synching EHRs with research systems.
CDER official comments on the significance of ICH's new alternative path for identifying the cardiac safety issue of QT prolongation in non-cardiac drugs.
View from Brussels
Renewed attention on ways to tackle this age-old scourge is building in Europe and beyond.
Clinical Trial Insights
Work burden and performance hurt by technology incompatibility.
Feature Article
Survey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
Why electronic informed consent is key to supporting today’s patient-centric mantra in clinical trials.
Outlining those technologies best able to raise the data and process quality of risk-based monitoring.
A Closing Thought
The need to involve regulators is crucial when the use of electronic data devices impacts the management of patient safety and evaluation of trial endpoints.
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