Dr Paul Passier, Scientific Director at Astellas Pharma, discusses the key considerations when recruiting for pediatric Phase I clinical trials and study design. Watch the full webinar presentation, as well as six other on-demand webinars here.
Running pediatric clinical trials offers a whole host of different challenges to those faced in adult trials. Ethically, informed consent is vital to get right when recruiting children, whilst placebo control trials, optimal dose selection, age appropriate formulation and extrapolating adult information to pediatrics can all pose issues.
In this exclusive 30 minute presentation, Dr Paul Passier explores how to address these concerns when getting a compound approved by the regulatory authorities for pediatric use.
He focuses largely on recruitment for Phase I and study design, emphasizing that the success or failure of a pediatric trial can rely on choosing the best time to start it:
'You can start too early if you don't have enough information - for example if your program is still in Phase II it could be stopped because of lack of efficacy and then you have exposed pediatric patients to a compound that won't make it to the market. This is considered not ethical.
But you can also start too late. Although the program can seem simple with very few patients , you should not underestimate the time it takes to recruit the patients and discuss your program with the authorities and for them to brief you. So before you know your patent is expired before you get your extension.'