Staff at Cedars-Sinai Medical Center had their hands full implementing two new major technology systems over the past two years. Then the pandemic hit, adding a huge burden to already-strapped employees, who managed a record 141 trial agreements by the end of last year. Read More

The switch to virtual site training during the past year has not only saved time and travel, it’s allowed staff to have access to quick on-demand reference materials from their training they can refer to as they encounter real-world situations. Read More

Four years ago, nearly all digital tools used in clinical trials were ECG devices, but 2021 data show that they have shrunk to 63 percent of the total, edged out by wearable devices, connected sensors, digital biomarkers and other new technologies. Read More

While the clinical trial landscape has seen a historic rise in trial starts year over year and shown a significant recovery from the far-reaching impact of the COVID-19 pandemic, there’s been a troubling burnout rate among clinical investigators, a phenomenon that concerns sites and sponsors. Read More

While much has been learned in the past year about decentralized and virtual trials, industry executives meeting last week at a SCOPE conference emphasized that virtual isn’t always the answer. Read More

Sites and sponsors have shown interest in permanently adopting technologies used during the pandemic to make trials more virtual and accessible to patients, but sponsors must be cognizant of the burdens such solutions can impose on sites and avoid using technology that would bog them down. Read More

From the lessons learned in the COVID-19 pandemic, the FDA intends to push for greater use of master protocols, decentralized trials and digital health technology moving forward, said Acting Commissioner Janet Woodcock. Read More

Sponsors working on developing drugs for rare diseases should increase their efforts to obtain natural history data, which can improve the rigor of their drug development programs and help support clinical trials. Read More

There’s often a rush to form data monitoring committees (DMCs) and get the organizational meeting out of the way as study initiation approaches, but sponsors and sites need to take time to make sure that plans for the group are solid before their work begins. Read More