In the push to accelerate research by shortening clinical trials’ duration, sponsors and sites need to be aware of the risks “fast science” can introduce and focus on trial designs that are proven to maintain scientific integrity while speeding results. Read More
Endpoint adjudication committees (EAC) can help direct trial design and data analysis plans, but sites, sponsors and CROs need to fully understand data expectations and set up for success when EACs are involved or risk hours of unanticipated work — and potential failure of the trial itself. Read More
Six EU countries have successfully turned up the heat on sponsors who haven’t shared the findings of their clinical trials, a new analysis finds. But some member states still appear to be making little to no effort on trial transparency, threatening current efforts within the 27-nation trade bloc. Read More
When faced with an FDA inspection, sponsors, CROs and sites must be ready to present trial master files (TMF) that are up to date and give a comprehensive account of the study. And the most efficient way to ensure they are is to maintain a constant state of inspection readiness with a regular TMF review schedule. Read More
Pharma and biotech sponsors are increasingly following the FDA’s lead in using real-world data (RWD) and real-world evidence (RWE) in clinical trials, according to a new survey asking about the most valuable resources for clinical trials. Read More
The staffing shortage in clinical research is an undeniable problem that’s only growing worse. Sweeping, radical change is needed to overhaul the current system for hiring new personnel, say industry leaders, particularly regarding restrictive experience requirements that currently bar entry to many promising candidates. Read More
Vanderbilt University Medical Center (VUMC), one of the Southeastern U.S.’s largest academic medical centers, starts digging in early to the details of the electronic data capture (EDC) systems to be used in its trials, an approach that’s helped the major institution smooth and speed trial activation and ensure staff are clear on all data collection and entry expectations. Read More
There’s no question that decentralized trial (DCT) methodologies have cemented themselves as a central part of the future of clinical research, but sponsors aren’t on the same page regarding their potential risks to good clinical practice (GCP) and how to mitigate them, a new survey shows, highlighting a critical need for greater dialogue, research and education. Read More
After more than a decade of facing barriers, direct-to-patient (DTP) shipment of investigational products is coming into its own now that pandemic conditions have prompted solutions to major transportation problems. Sites and sponsors now have more DTP options, but there are still some kinks to work out and regulatory guidance needed. Read More
Trials that identify prospective participants before activating a site can not only increase efficiency and reduce effort, they can enroll participants who are more reflective of actual disease populations, according to one group that intends to put this “just-in-time” (JIT) trial approach to the test in oncology. Read More