As the medical community shifts much of its focus — and its resources — to battling the ongoing COVID-19 pandemic, clinical trial sponsors and sites are left wondering what to do about ongoing drug and device studies unrelated to the coronavirus. Which studies should be paused and which should be allowed to continue? Could modifications to study protocols around data collection and patient visits strike a balance between maintaining both patient safety and the integrity of ongoing trials? Read More
As the medical community shifts much of its focus — and its resources — to battling the ongoing COVID-19 pandemic, clinical trial sponsors and sites are left wondering what to do about ongoing drug and device studies unrelated to the coronavirus. Which studies should be paused and which should be allowed to continue? Could modifications to study protocols around data collection and patient visits strike a balance between maintaining both patient safety and the integrity of ongoing trials? Read More
As difficult as the informed consent process can be in adult trials, involving children in studies adds unique and complex challenges, says one pediatric research expert. Read More
Investigator’s brochures (IBs) are meant to be a living document, updated at least once a year to keep up with progress and developments in the trial.
But scheduling and drafting updates can prove challenging, says Tiffany Guckin, associate director of regulatory affairs for Invicro, an imaging services and software company.