Virtual training for study startup is not only saving time and money, it’s providing more in-depth learning and improved communications between sites and sponsors. Read More
Data, quality and trial management top the list of ways the industry is using artificial intelligence (AI) and machine learning (ML), according to a new survey of the technologies’ impact on clinical trials. Read More
Researchers at the Tufts Center for the Study of Drug Development (CSDD) have developed and tested an algorithm that can calculate a single numerical patient burden score for a clinical protocol. Read More
Sites and sponsors are working toward improving the site qualification process, which is cumbersome, time-consuming and can be costly. Solutions range from data-driven technological tools for sharing information to paring down feasibility processes. Read More
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
