Children who participate in pediatric trials as well as their parents say the trials are overly burdensome and disruptive, according to a recent survey. Read More
While the clinical research and drug manufacturing sectors operate under mostly different priorities, they share a commitment to quality management. And with manufacturers’ long history of operating under quality management regulations from the FDA, drug- and devicemakers have developed some best practices clinical trial sites are adopting to improve their culture of quality. Read More
Cybersecurity in the clinical research world is “a little bit special,” one expert says, because sites must deal with confidentiality, data privacy and integrity, as well as the breach notification process imposed by regulators. And never has the threat to trial data been so high. Read More
The impact of COVID-19 will continue well into 2021, and sites and sponsors already are looking at how new methods, new collaborations and lessons learned during the pandemic can be applied in the years ahead to reduce trial costs and timelines, increase participation and strengthen electronic solutions to make trials more effective and efficient. Read More
In the past, drug trials have taken months or years to conduct with reams of data to analyze before a sponsor could go to a regulator for product approval. But under the emergency conditions caused by the pandemic, vaccine approvals will be based on early data analysis and much smaller data sets. Read More
Industry experts agree that 100 percent virtual trials won’t work for all types of studies, but they predict that by 2025, all trials will have at least some virtual component that offers flexibility in how sites interact with participants and makes trials more accessible and more appealing to the public. Read More
Clinical trial safety reporting procedures have always been a challenge for sites, taking a disproportionate amount of time and money, but three factors are making the task even more difficult and lengthy for today’s sites: sponsors that over-report, lack of global harmonization of reporting rules and the pressures of a global pandemic that require rapid response. Read More
Sites are being asked to do more with less as revenues and resources decrease at the same time sponsor demands for COVID-related trials increase. But altering the dynamics between sites and sponsors may be part of the solution. Read More
No matter how the data are crunched, the challenge remains that trials need to come up with new approaches for persuading reluctant minorities to participate in trials. And the problem has been exacerbated by the pandemic. Read More