The number of industry-sponsored oncology trials dropped by 60 percent worldwide in the opening months of the pandemic, derailing what had been a steady annual increase since 2015. Read More
Clinical trial researchers should include input from patients before the trial design and consent process even begins to ensure that minority participants feel included and that all study participants stay engaged until the study is complete. Read More
Faced with evolving variants of the SARS-CoV-2 virus, COVID-19 vaccine-makers are considering tweaks to their current products that would call for only small safety-focused trials rather than entirely new phase 3 trials, and the FDA has signaled its approval of that approach. Read More
Despite FDA support, master protocols have been slow to take hold in the U.S. due to reluctance and lack of coordination among the trial industry to take on such large-scale studies. But researchers who have been busy setting up and running master protocols during the pandemic say the challenges in the U.S. are surmountable with advance planning that includes streamlined contracting, expedited IRB approval and site staff training. Read More
Sites, sponsors and CROs are increasingly using integrated endpoint approaches that examine electronic patient-reported outcomes (ePROs) in clinical trials to eliminate the subjective nature of the data and root out any errors. But as the use of ePROs in trials is growing, the challenges of using them effectively to support endpoints are coming into focus. Read More
Despite impediments brought on by the pandemic, sites and sponsors are increasingly turning to biobanks for more than just storage of trial specimens, using them to manage and analyze data, inform trial design and open new avenues of drug development research. Read More
Risk management may be an integral part of conducting a trial, but in the past year sites have been overwhelmed with emergency measures needed to keep their trials running, leaving them little time to attend to the formal processes of identifying, assessing and mitigating risk. As the COVID-19 crisis eases in coming months, however, sites will need to refocus their attention and efforts on their risk management programs. Read More
The average number of trial endpoints has increased by 6 percent on average each year since 2003, leading sites to struggle to meet sponsor deadlines and overwhelmed by the amount of work required to handle such complex trials. Read More
Technological innovation in clinical trials could slow once again as the global health crisis eases and sponsors calculate their return on investment (ROI) for the innovations they adopted during the pandemic. Experts say remote monitoring, telemedicine and the increased use of decentralized trial approaches have proven their worth and are here to stay. Read More