SPOTLIGHT -
Califf: More Informative Clinical Research Key to Drug Development
FDA's new commissioner advocates for a "learning healthcare system" and less-complex clinical trial models that tap efficiencies in study design and enrollment.
EMA Releases New Advice on Human Trials for Cancer Drugs
The agency is concerned about the lack of non-clinical models with good predictive properties in the oncology space.
Number of Countries in Phase III Studies Remains Steady
Trend doesn't seem to fall in line with the perception of an increasingly complex trial protocol climate.
Will EMA Rules Calm the Disclosure Debate?
New policy hopes to calm the fervor around clinical trial data disclosure and confidentiality issues.
Acknowledging Cycle Time Impact from Protocol Amendments
Study provides real metrics on the trial-scope affects of protocol changes-shedding fresh light on the importance of adopting new strategies to reduce select amendments.
The Promise of Precision Medicine
For programs such as the Precision Medicine Initiative’s Cancer MoonShot to have a chance at success, following a set of key technology mandates will be critical.
Learning from Failure, Leveraging Biosimulation for Pediatric Drug Development Success
Pediatric trials now feature increased modeling and analytics for safer drug dosing and response.
Value-Based Planning & Drug Development Productivity
How to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
Overcoming Early Phase Oncology Challenges
How to meet the rigorous safety and efficacy demands critical to evaluating newer targeted cancer therapies.
Imagining the Impossible: Immunity to Cancer
The smaller biopharmaceutical company perspective on mastering oncology immunotherapy clinical trials.
Applied Clinical Trials, April/May 2016 Issue (PDF)
Click the title above to open the Applied Clinical Trials April/May 2016 issue in an interactive PDF format.
