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Applied Clinical Trials-09-01-2018
Applied Clinical Trials
Can FDA Put Some Heat Back Under European Adaptive Pathways?
September 01, 2018
News
27
9
Peter O’Donnell gauges the impact of FDA guidance on igniting the adaptive pathways debate in Europe.
Next-Generation Clinical Trials
September 01, 2018
From the Editor
27
9
A look at current strategies from the industry that address the limitations in clinical trials.
Clinical Trials In a Dish: A Revolution Begins
September 01, 2018
Feature Article
27
9
The emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.
EU’s Status on IDMP
September 01, 2018
News
27
9
Insights into the implementation of IDMP in the EU.
Applied Clinical Trials, September 2018 Issue (PDF)
September 01, 2018
Issue PDF
27
9
Click the title above to open the Applied Clinical Trials September 2018 issue in an interactive PDF format.
Ensuring High-Quality Data in Complex, In-Home Clinical Trials
September 01, 2018
A Closing Thought
27
9
To support complex in-home clinical research and investigative sites, well-designed trials must produce the same high-quality data as traditional sites.
FDA Promotes Surrogate Endpoints, ‘Seamless’ Clinical Trials
September 01, 2018
News
27
9
Jill Wechsler details new FDA policies to streamline drug development, including the design of “seamless” trials.
Genetic Testing in Clinical Trials: A New Level of Patient Centricity
September 01, 2018
Feature Article
27
9
Industry experts look at how the specific needs of patients come into play when conducting gene-based screenings.
Q&A: Clinical Trials Need To Grow In Relevance
September 01, 2018
News
27
9
One nonprofit’s efforts to raise the relevance of the clinical research enterprise.
Designing and Executing a Gene Testing Counseling and Disclosure Process
September 01, 2018
News
27
9
Alzheimer's Prevention Initiative's discusses a genetic counseling and disclosure model for its Generation Program.
Leveraging Modeling & Simulation in Oncology
September 01, 2018
Feature Article
27
9
How the use of M&S in cancer trials from the outset can help address those critical “what if?” scenarios and accelerate oncology drug development.
Pediatric Oncology Clinical Trials in Sub-Saharan Africa
September 01, 2018
Feature Article
27
9
The region is significantly underrepresented in clinical development activity targeting childhood cancer.
Bridging Research and Clinical Care
September 01, 2018
Survey Spotlight
27
9
Insights on the challenges, activity, and motives in merging bridging research and clinical care.
Site Models of the Future: Finding Patients Faster
September 01, 2018
News
27
9
Site models that meet patient needs at the site level.
The Future of Mobility and Medicine
September 01, 2018
Feature Article
27
9
The role of the cloud in realizing the practical benefits of mHealth in clinical trials.
Q&A: Expanding Clinical Research Access
September 01, 2018
News
27
9
Partnership focuses on integrating research into the care continuum.
Challenging the ‘Site-first’ Status Quo in Patient Enrollment
September 01, 2018
Feature Article
27
9
Case study highlights a new patient-centric enrollment model that uses a data-driven approach to identify qualified patients first.
Placing a Premium on Informed Upfront Planning
September 01, 2018
Clinical Trial Insights
27
9
Reexamining traditional cycle-time reduction strategies is critical for sponsors, CROs, and sites.