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

Misinformation and mistrust are two of the biggest culprits behind minority groups’ reluctance to participate in COVID-19 trials, but community outreach, education and replacing fake “facts” with real ones are the first steps in easing their fear of clinical research. Read More

Sponsors and CROs are not embracing the kinds of progressive quality management methods, such as predictive quality metrics, quality tolerance limits and automated metric dashboards, encouraged by regulators, according to a new survey that found the two groups share a perception that such tools are less effective than traditional methods. Read More