In our December issue
FEATURED
China: Regulatory Reform Update
Lizuan Chen, Yumin Li, Chunyan Liu, Daniel Liu
In recent years, China’s National Medical Products Administration has been making efforts to accommodate ICH standards and requirements, and strengthening measures to improve drug and medical device administration systems. Authors present the most significant changes and current requirements in processing INDs and NDAs in China.
Reshaping Toxicology Data Analysis
Sony Salzman
The industry is on the cusp of a revolution in the way toxicology studies are cataloged, analyzed, and leveraged. Driving this change is FDA’s long-running Standard for Exchange of Nonclinical Data (SEND) initiative, which has spawned new partnerships with industry around the promise of cross-study analysis.
New Avenues in Heart Failure Research
Kuldeep Singh Rajput
FDA is urging drugmakers to look beyond traditional hard outcomes, such as mortality and hospitalization, in heart failure clinical trials. To that end, this report explores a new FDA-funded digital biomarkers study focused on measuring patient quality-of-life endpoints.
Orphan-Drug Submission Guide
Kevin Barber
Amid recently issued FDA guidances on developing treatments for rare diseases, article examines the unique considerations involved in preparing and submitting marketing applications for orphan product candidates.
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NEWS
Eye on Patient Advocacy: Latest column in series looks at a potential “driver” in reducing transportation barriers to trial participation.
Washington Report: Jill Wechsler on the notable policy strategies advanced in 2019 to boost drug development and review.
EU Report: Peter O’Donnell explores where the EU stands today in R&D pursuits for new antibacterial therapies.
Q&A: How one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.
Data Management: The shift from paper to cloud-based regulatory information management systems (RIMS) to address operations challenges.
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CLINICAL TRIAL INSIGHTS
Can Recruitment and Retention Get Any Worse?
Ken Getz
Higher screen failure and patient dropout rates are raising the imperative to pilot and implement new study conduct models in trial recruitment and retention.
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CLOSING THOUGHT
Virtual Studies and Compliance
Laura Podolsky
Navigating the nebulous regulatory pathway for virtual studies requires a thorough understanding of the operational challenges and how to apply existing legal frameworks.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lhenderson@mmhgroup.com
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