There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions that center on documenting outcomes within these patient populations.
In this webinar, the featured speakers discuss challenges in implementing clinical studies in children and creative solutions to effectively implement them.
- Clinical trial design
- Regulatory considerations
- Pre-study considerations
- Implementation and operational challenges
- Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research
- Heather McKenney, Senior Director, Program Delivery, Rare Disease and Pediatrics, Premier Research