Features

WHO: Focus on Biosimilar Differences

August 6, 2018

Clinical trials of biosimilars should focus on how they differ from the drugs they copy rather than on creating a whole new safety or efficacy study, the World Health Organization says.

FDA Posts First List of Surrogate Endpoints

July 30, 2018

The FDA has published the first-ever list of surrogate endpoints, giving sponsors the first concrete suggestions for the kinds of laboratory measures or physical signs that might help develop drugs even when clinically meaningful data proves elusive.

New Guidance for Multiregional Clinical Trials

July 23, 2018

The FDA has issued new guidelines designed to help researchers navigate sometimes conflicting regional requirements and differences in global clinical trials in an effort to pave the way for better cooperation and faster international drug development.

New Report: Improving Clinical Site Payment Practices

July 23, 2018

Paying sites on time is critical to a trial’s success, sponsors agree, and most believe they’re making the grade. So why are sites so frustrated with how they’re paid? Are their expectations unreasonable or are sponsors operating in the dark?

eCOA: Keep It Simple, Exec Argues

July 16, 2018

Clinical trials have not yet fully entered the digital age. Despite a revolution in consumer electronics that has built libraries of real-time personal health data, sites and sponsors seem to regard digital technology the same way Saint Augustine prayed for chastity and continence: “Grant them to me, O Lord — but not yet.”

Finding Good Sites in Today’s Competitive Site Landscape

July 9, 2018

The biopharmaceutical industry now spends $500 million on Big Data in the hopes of finding great investigators and streamlining trials — and yet 23 percent of sites never enroll a single patient and 80 percent of all trials are still delayed.