The devil, as the old saying goes, is in the details.
The growing influence of genetic testing in clinical trials has offered patients seemingly miraculous results. But it also has the potential to bedevil researchers who don’t carefully manage the enormous amounts of information that genetic testing can bring. Read More
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.
The FDA’s guidance on Data Management Committees will expire by the end of the year, but even if it’s not extended, the principles behind them will endure. Read More
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.” Read More
Researchers’ inability to recruit minorities into clinical trials may have warped heart disease prevention guidelines, a new study is claiming — highlighting an ongoing problem for the industry. Read More
Sites and sponsors should have a lot of leeway in determining how to measure patient experiences during drug development, but researchers should take care that whatever sampling methods they provide are a fair representation of that target population, the FDA said in a new draft guidance issued June 12. Read More
A new reorganization at the FDA’s Center for Drug Evaluation and Research will assign multidisciplinary teams to work on new drug applications from the beginning of the regulatory process, will centralize project management under the Office of New Drugs, and increase the number of offices overseeing review divisions from five to nine and increasing the overall number of review divisions from 19 to 30, the agency announced June 4. Read More
Patients overwhelmingly feel that the benefits of clinical trials outweigh the risks to their personal privacy, according to a new study in the New England Journal of Medicine. Read More
Recruiting patients for a clinical trial can be a long and expensive process, but smart trial sponsors and sites use a mix of traditional and new media in order to maximize their recruiting budget, a veteran patient recruiting consultant said. Read More
Blockchain technology offers a lot of promise to sites but it can also destabilize those companies that don’t properly prepare for it, a site executive warned her fellow professionals Tuesday. Read More