Applied Clinical Trials August 2016

August 2016 | Volume 25, Issue 8
The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.
The uncertainty surrounding where the agency and its 890-member staff will call home next may linger for months, if not years.
Janssen releases key findings from its pilot study evaluating the use of electronic informed consent technology in clinical trials.
A patient-centric approach to a Phase IV trial for an MS treatment resulted in lessons that can be applied to future therapeutic studies for this and other rare diseases.
More precision models in connecting patients to clinical trials and treatment options are vying to close the ever-elusive recruitment gap.
Survey delves deep into what constitutes true game-changing innovation in clinical development.
Issue PDF
By Applied Clinical Trials Editors
Click the title above to open the Applied Clinical Trials August/September 2016 issue in an interactive PDF format.
View from Brussels
A look at the EMA’s proposed guidance revisions for first-in-human studies.
Clinical Trial Insights
Research reveals a need for sponsors to be much more consistent, disciplined and focused in their CRO usage.
Feature Article
A proposed operational framework to support digital- and mHealth-based clinical trials in Africa.
This article explores the potential value of cross-company collaboration around data sharing and integration—and the impact on study planning, investigator selection, site start-up, and internal master data management.
An examination of recent failures in Phase III studies and innovative approaches to reduce risk.
Study measures the differing judgment levels between clinical investigators and drug safety experts.
A Closing Thought
The need to move beyond a point-solutions approach to one built around applications designed to manage the end-to-end clinical trial process is crucial.
lorem ipsum