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In our May issue:

PEER-REVIEWED ARTICLES

Master Protocols in Oncology
Bradley Smith, Kathy Giusti, Richard Hamermesh, Dixie-Lee W. Esseltine
With technology's increasing ability to gather and analyze previously unmanageable data sets, and medicine's forays into genomics and targeted therapies, the time of the master protocol may be at hand. Authors explore what it will take to make the master protocol a standard in oncology research.
Cancer Immunotherapy Trials: Steps to Success
Luke S. Gill
Immune checkpoint inhibitors have changed the landscape in immuno-oncology, and emerging therapies such as CAR-T, dendritic cell vaccines, and bi-specific T-cell engager antibodies are advancing the terrain further. At the same time, sponsors will need to overcome critical hurdles that are inherent in developing immunotherapeutic agents and the unique standards required when assessing safety and efficacy.
NEWS

Washington Report: Jill Wechsler interviews FDA Commissioner Scott Gottlieb about his push for more efficient R&D to help lower drug prices.

EU Report: Peter O'Donnell explores potential parallels of the U.S. “right-to-try” debate in Europe.

Q&A: Bristol-Myers Squibb executive discusses the biomarker landscape—and the role of translational medicine in accelerating this area of research.

CISCRP CORNER

Patient Perspectives on Seeing Trial Results
CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger
The third in a series of results from the Center for Information and Study on Clinical Research Participation's (CISCRP) landmark 2017 Perceptions & Insights Study.
CLOSING THOUGHT

Explaining the Clinical Innovation Gap
Bagrat Lalayan
Though digital technology has improved the R&D process, when it comes to important clinical benefits and outcomes, modern biotech products have rarely shown the advantages of older generations of drugs.
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issue:
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BLOGS
Blockchain Concepts Emerge in Clinical Trials
FDA Moves to Overhaul New Drug Review Process
Privacy and Provenance
WEBCAST
How to Increase Efficiency in Early Phase Trials
Learn about creative strategies that are emerging in early clinical drug development, including combined protocols, patient cohorts, and implementation of new biomarker technologies and adaptive study designs.

If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - [email protected]

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