News

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

What started as an initiative called Risk-Based Monitoring several years ago is now evolving into Risk-Based Quality Management of clinical trials with a much wider impact to the pharma industry.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

Examining the implications of shipping temperature-sensitive clinical supplies in an evolving clinical supply chain, including shipments direct to patient homes (DTP) and the need for temperature monitoring thereof.

Recent initiatives demonstrate that European health authorities are serious about combatting the proliferation of threats and opportunities from big data.

Survey uncovers deeper learnings of patient perceptions of clinical research and the motivations to participate.

FDA officials provide more specific plans for streamlining and modernizing plans for assessing and regulating products for cutting-edge cellular and gene-based medical treatments.

Click the title above to open the Applied Clinical Trials March 2019 issue in an interactive PDF format.

Patient advocacy organizations are swaying away from a traditional model of granting academic researchers to now supporting biotechnology and pharma companies.

Patient advocacy groups, patient centricity initiatives, and patient education are the key to putting patients at the center of clinical research.

In this Q&A, Helen Matthews, Jessica Morris, and Bruce Hellman offer their perspectives on the priorities, opportunities, and challenges of patient centricity in real-world evidence collection.

Optimization model evaluates the benefits of selecting a portfolio of investigative sites based on advanced analytical models.

Examining the distinct actions and advocacy that have advanced the concept from buzzword status to practical implementation in clinical studies.

It’s time to establish standard practices to return clinical trial results summaries to patients.

Europe is gradually attempting to maximize the potential of the scattered data that, if brought together, might help improve diagnosis and treatment of Europe's 30 million rare disease patients.