Sites and sponsors should conduct certain analyses with their trial data during COVID-19 to determine empirically whether their data capture methods remain valid because of the impact the pandemic is having on how patients are reporting outcomes. Read More
The FDA is conducting clinical trial oversight through informal remote review of site, sponsor and CRO records while the COVID-19 pandemic is limiting the agency’s ability to conduct traditional on-site inspections. But the agency stresses that these reviews are not taking the place of formal inspections and possible enforcement actions. Read More
While sponsors, CROs and sites are increasing their use of electronic data management systems, they are finding the biggest challenge is getting multiple tools and platforms to work together seamlessly, according to two recent surveys. Read More
Clinical trial timelines have been lengthening since 2014 and with COVID-19 conditions forcing adaptation and adoption of new technologies and processes, the trend is likely to continue, if not accelerate. Read More
Sponsors looking to increase diversity in clinical trials should, among other things, “meet patients where they are,” hire a more diverse pool of trial investigators, train nonminority investigators and deploy a patient-centric model for trials that includes input from Community Advisory Boards (CABs). Read More
The amount of time to complete clinical trials for anti-infective drugs is almost 14 percent shorter than for other drugs approved by the FDA over the past 20 years, according to a new study. Read More
The clinical trial ecosystem wasn’t built to handle the demands of a global health crisis and isn’t generating the level of evidence required for regulatory decisionmaking, says an FDA-backed coalition that is developing a five-point strategy for making trials more effective and their data more relevant. Read More
Trial professionals should be using risk-based quality management (RBQM) to bolster their corrective and preventive action (CAPA) plans, which too often focus on the “CA” part of the equation but don’t follow through on “PA.” Read More
There’s a lot of debate about why minority participation in clinical trials is so low — problems with access, lack of awareness and mistrust of the research community, to name a few — but some practical outreach strategies can go a long way to making trials more racially diverse, especially important as the industry seeks a cure for COVID-19. Read More
Patient privacy has become more top of mind as the COVID-19 pandemic continues and a larger part of the population is participating in clinical trials. Read More