Sponsors and sites need to do a better job analyzing suspected adverse events before sending reports to the FDA, say two senior agency officials, who fear that the current over-reporting they see may lead to missing important safety signals. Read More
A clear focus on hybrid solutions and customization to a site’s needs will be the hallmarks of clinical trials postpandemic, along with a strengthened ability to shorten trial timelines. Read More
As the clinical trials industry looks back on what has been an incredibly disruptive year, questions are being raised about what to expect in 2021. One thing is certain: a return to normalcy is not in the cards although there is cause for hope about how COVID-19 has altered the clinical trials landscape. Read More
There’s no getting around making careful coverage analysis (CA) determinations. It’s an essential part of what sites need to do to stay compliant on billing practices. However, questions do arise in areas where there is little to no guidance. Here is an overview of some of those problem areas and what experts suggest are possible solutions. Read More
As part of its ongoing efforts to make clinical trials more representative of the population, the FDA last week issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. 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
As the industry moves beyond the pandemic, sites and sponsors must ask themselves which practices developed to meet the needs of remote operations should carry forward and, ultimately, who will cover the cost of new technology and methods. 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
COVID-19 has given the clinical trials industry the push it needed to go paperless, with 84 percent of sites, CROs and sponsors already doing so or poised to make the switch to electronic data management (EDM) systems. Read More
The first wave of COVID-19 vaccine development has not monitored the response of T cells to the virus, a missed opportunity that should be addressed in the next wave of COVID-19 research, two experts said last week. Read More
