The FDA has made it clear sponsors should start now to develop diversity action plans with the help not only of guidance released last year but also the promise of more guidance to come and the offer of consultation with the agency itself. Read More
Healthcare workers’ levels of stress rose to a new high of more than 40 percent in 2022, putting them at greater risk of health and work performance issues, according to the latest in a series of annual surveys. Read More
Following a request for information by the White House’s Office of Science and Technology Policy (OSTP), a number of industry groups offered suggestions for priming the U.S. clinical research infrastructure to effectively respond to future public health emergencies. Read More
Recruitment and retention plans will always be molded by the specific trial and population involved; putting careful thought into who your trial’s target participant is can help bolster enrollment/retention numbers, an expert advises. Read More
Using trial participant diversity as its roadmap, one site network has taken decentralization to its farthest limit by operating solely as a fleet of “sites on wheels” to serve communities that have little to no access to clinical trials.
Despite sites calling for a reduction in the amount of burdensome protocol amendments from sponsors, a newly published study shows that the prevalence and average number of amendments are still on the rise. Read More
Sites are often advised on things they can do to improve the payment process on their end, but sponsors can also take action to make sites’ financial situations significantly less stressful, according to one sponsor representative.
With recent data driving home the challenges faced on enrollment, staffing and protocol complexity this year, sites are saying they want to know what to expect from sponsors on a range of items, including timelines, feasibility, training and technology, among others. Read More
Evidence generation has undeniably grown beyond traditional trials to include a number of other sources and continues to evolve. Amy Abernethy, former FDA deputy chief, sees a future in which therapies are approved earlier and continually evaluated with high-quality data, but it will be on industry to connect the dots and build a strong foundation to make this a reality, she says. Read More
When clinical trial stakeholders meet, a major focus of discussion is the concept of collaboration and the industry’s inefficiency in adopting innovations. Read More