Premier Research released a new survey regarding pediatric trials and reglations earlier this month. Applied Clinical Trials was able to speak with Charli Sanders, MD, Premier Research Vice President, Regulatory Affairs and Pediatric Consulting about what she hopes the future of pediatric trials brings and how these trials have already started to change.
What has changed in pediatric trials over the last few years?
For one thing, pediatric clinical trials have gotten more costly. It's not that the regulations have changed so much as enforcement of pediatric regulation compliance is becoming more rigorous. Additionally, under PREA (Pediatric Research Equity Act of 2003), the FDA has leverage to require more rigorous and comprehensive pediatric programs than previously have been requested. Consequently, procrastination can prove costly.
How do you think the results of this study will differ in the next five years?
In terms of how this survey's results will be different in five years, hopefully the biggest change will be that companies will understand and be more comfortable with the process, and will have developed a systematic method for complying.
Look for a more detailed overview about the Premier Research survey in our June issue.