Strategic planning and execution are crucial when implementing rare disease clinical trials, especially when factoring in the added complexities of pediatric rare disease trials.
There are many operational and regulatory challenges to consider when planning for pediatric rare disease clinical trials. Without careful, strategic planning to tackle these challenges, trials may be fraught with operational hurdles which can delay recruitment and other study milestones. Understanding potential challenges and pitfalls and setting realistic regulatory expectations are critical when developing study timelines and strategies.
On Rare Disease Day, Medpace experts shared operational and regulatory challenges associated with pediatric rare disease clinical trials, along with strategies to help anticipate and overcome them.