Applied Clinical Trials April 2019

April 2019 | Volume 28, Issue 4
Applied Clinical Trials April 2019 Issue
Issue PDF
By Applied Clinical Trials Editors
Click the title above to open the Applied Clinical Trials April 2019 issue in an interactive PDF format.
From The Editor
With emerging biopharma being their latest boom of customers, CROs should be more mindful of their smaller clients and pay more attention to handling their needs.
News
The agency released four new draft guidances in an effort to broaden outmoded criteria for identifying and enrolling patients in clinical trials.
Peter O’Donnell looks at the communication gaps in relaying the role and importance of translational research in Europe.
A leading industry executive in the regenerative medicine space discusses recent advances in stem cell therapy development.
Feature Articles
Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.
A look at the scope of the agency’s draft framework for evaluating the use of RWE to support new drug approvals and the implications for sponsors.
With outcomes from “real life” a critical compliment to clinical trial data, the importance of involving an epidemiologist at study inception is explored.
A Closing Thought
As clinical trials move to more agile means of data capture, the use of "citizen data scientists" to handle the less complicated work in data management is on the rise.
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