Protocol deviations can pose serious risks to clinical trials, including regulatory troubles, study delays and, ultimately, failure to launch an approved investigational product. But despite the importance of following study protocols, deviations remain a consistent problem in the industry, regularly topping the list of problems found during FDA inspections of research sites. Recent figures indicate that the average phase 3 trial has 118.5 deviations per protocol that affect nearly 33 percent of enrolled participants. Read More

The word “innovation” is almost synonymous with the word “change,” but the former has a positive feel while the latter can have a negative connotation for risk-averse individuals and organizations alike. And few industries are as risk-averse or as in need of innovation as the clinical trials field. Read More

In response to requests for more time to weigh in on a pair of long-awaited proposed rules on IRB review and informed consent requirements, the FDA has extended the comment period to Dec. 28. Read More

Trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential impact on participants’ physical growth and sexual development, according to recent FDA draft guidance. Read More

With a goal of facilitating the seamless exchange of clinical trial protocols, the International Council for Harmonization (ICH) has published draft recommendations for their structure and content. Read More

Seeking to help sponsors avoid making false efficacy conclusions in drug and biologic trials that use multiple endpoints, the FDA has published final guidance on grouping and ordering endpoints for analysis and statistical approaches for managing them. Read More

Both clinical and surrogate endpoints are acceptable targets for trials investigating gene therapies (GT) for neurodegenerative diseases, according to finalized FDA guidance on developing these products. Read More

The European Medicines Agency (EMA) has endorsed the International Council on Harmonization’s (ICH) guideline on ways to be more selective in collecting safety data in late-stage and postmarket trials. Read More

The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More