Many companies, particularly new entrants into the U.S. pharma arena, are facing some level of disruption or impact on their projected timelines for seeking FDA licensure, gathering data from trials for filing, conducting health economics analyses needed to demonstrate improved outcomes, or conducting real-world evidence studies that can help inform medical societies’ deliberations on clinical […]
Clinical trial delays not only impact the current path forward but potentially (depending on the extent of the delay/disruption) can create hurdles for future regulatory filing, approval and launch. Therefore, as with all functions being affected by the pandemic, adaptability will be critical.
Many companies are facing challenging decisions on whether to proceed with clinical trials in the coming months as countries experience varying degrees of lockdown.
Medical congresses – crucial for the presentation of trial data, scientific exchange and the opportunity to engage with medical professionals, patient advocates, media and analysts – have been cancelled, postponed or are moving to virtual/part virtual.