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
A panel of Alzheimer’s disease (AD) experts has developed a plan to break down barriers to trial enrollment and accelerate research to keep up with the expected increase in the disease’s prevalence in the coming decades. Read More
Sponsors are increasingly using questionnaires to gather data and feedback from trial participants on their experience with the investigational product and the trial in general as part of a push to enhance engagement. And while participants usually appreciate the opportunity to contribute, too-frequent surveys can wear on their patience and create additional work for site staff. The question that must be considered is “how do you create a balance between benefit and burden for both participants and staff?” Read More
A broad collaboration among regulators, academia, the nonprofit sector and sponsors has developed a framework for creating less restrictive eligibility criteria for lung cancer trials that can be applied across the oncology research sector and beyond. Read More
There’s considerable buzz around the idea of letting trial participants use their own electronic devices to run trial apps, and the strategy has risen in popularity alongside the decentralized trials (DCT) movement. For sites unfamiliar with BYOD (bring your own device) trials, planning and prepping with the technology in mind is essential to managing this still evolving model successfully. Read More
The clinical trial payment process has long been frustrating for sites as well as sponsors and their CROs, with uncertain invoicing procedures, misunderstandings around payment terms and data entry complications often leading to late, incorrect or missed payments. Add to the picture the trend toward increased trial complexity, adoption of new technologies and the use of decentralized trial (DCT) methods, and all parties are feeling the pinch of payment problems more than ever. Read More
Sponsors, sites and academic institutions generally agree that the clinical trials industry needs formalized education programs and requirements for trial professionals, especially in light of a new survey that shows large competency gaps in several core areas.
Sponsors take an average of six years to adopt innovations intended to increase trial efficiency, according to findings from a new global survey. Now, an industry that moved at unprecedented speed to adapt to the COVID-19 pandemic is looking to leverage that experience and identify ways to shorten the six-year innovation cycle. Read More
