Applied Clinical Trials-06-01-2016

Applied Clinical Trials

‘Breakthrough’ Program Generates Optimism — and Concerns

June 01, 2016

News

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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.

Antibiotic-Resistance Focus Could Benefit Clinical Trials

June 01, 2016

View from Brussels

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Renewed attention on ways to tackle this age-old scourge is building in Europe and beyond.

EFGCP Renews Campaign on Older People in Research

June 01, 2016

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European forum tackles the problem of limited elderly patients involved in clinical trials.

EHR eSource: Sword of Change?

June 01, 2016

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Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.

Critical Update to Cardiac Safety Assessments

June 01, 2016

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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.

Applied Clinical Trials, June/July 2016 Issue (PDF)

June 01, 2016

Issue PDF

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Click the title above to open the Applied Clinical Trials June/July 2016 issue in an interactive PDF format.