Master Protocol Guidance in Cancer R&D: Impact on Industry
FDA draft guidance for modernizing the approach to clinical trial design for oncology drugs and biologics look to make clinical trials more efficient while maintaining patient safety.
The Benefits of RWD & RWE in Oncology Trials
C.K. Wang, MD, senior medical director at COTA Inc., discusses the impact of RWD and RWE in clinical oncology.
Glimpsing the Future of Clinical Trial Design
A look at three contemporary trends that though integrated cautiously at first, may open up a reimagined world of clinical research.
FDA Facilitates Expanded Access for Cancer Drugs
A look at the latest oncology stats and information most applicable to the clinical trials industry practice.
Real-World Evidence Gains Traction for Informing Clinical Research
Researchers and sponsors are looking to use RWE information to help in trial design, product use, developing new therapies, and gaining market approval.
News Notes
A compilation of recently released news briefs that pertain to the clinical trials industry.
Applied Clinical Trials, June 2019 Issue (PDF)
Click the title above to open the Applied Clinical Trials June 2019 issue in an interactive PDF format.
Navigating Drug Development Through More Turbulent Waters
The World Health Organization tries to find a balance with its Road Map for Access on how to best approach research and pricing in Europe.
Building a Physician Referral Network: A Case Study
Exploring the Institute for Neurodegenerative Disorders’ non-traditional approach to engaging community physicians.
Predicting the Probability of Success in Clinical Drug Development
Undertaking an assessment of the POS can be coupled with the product profile and safety assessments of compounds prior to launching a clinical trial.
Reveling in 2018's Revealing Drug and Biologic Approvals
Record numbers point to new R&D operating environment, driven by a changing community of sponsors.
De-risking Master Protocol Implementation
Using a risk-based model to navigate the inherent changes and fluctuations in master protocol studies-and help maintain data integrity throughout.
Clinical Research as a Care Option: Optimizing Approaches
Examining the fundamental changes required to successfully integrate clinical research into mainstream healthcare.
