Implementing an electronic regulatory (eReg) system can seem daunting to sites when it comes to the costs and time involved, but those that commit to it can reap multiple benefits, including faster study startup, increased efficiency and decreased long-term costs. Read More
A number of early warning signs can indicate a site may be headed for trouble, both operationally and financially. Weak research strategies, misaligned incentives and poor business development functions can lead to low enrollment, budget overages and, ultimately, failed trials. Read More
Sites can add depth to their research teams by creating specialized positions and potentially free up existing staff to take on more trials. The challenge is in site managers or directors convincing site leadership — typically vice presidents — that the gains outweigh the costs. Read More
Although decentralized trial (DCT) approaches have been largely responsible for keeping trials afloat during the pandemic, a major drawback for sites has been not only the number of vendors they require but also sponsors’ failure to consult the sites that will work directly with those technology and service providers. Read More
Sites should take an “all-hands-on-deck” approach to protocol review, engaging all study team members to ensure they’re taking on trials that are well-designed, operationally feasible and devoid of as many pitfalls as possible, according to one expert. Read More
Sponsors and CROs are shifting away from the traditional wide-net approach and focusing more on investing in fewer numbers of sites. Should this trend pick up speed as some project, sites may need to adapt best practices, embrace sponsor-driven changes and keenly address their shortcomings to remain competitive. Read More
A troubling trend is being seen in clinical research: sponsors frequently overestimate their oncology trial budgets while underestimating budgets in other areas, creating challenges for sites trying to prepare for and manage trials. Read More
Sponsors want to get more out of a site evaluation visit than a checklist of the site’s capabilities; they want a sense of the site’s enthusiasm for the trial and an understanding of its goals, according to one experienced CRA. Read More
Sponsors and indirectly sites are still not where they need to be on meeting postmarket trial requirements and commitments, the FDA’s latest analysis shows: 24 percent of annual status reports for required or agreed upon postmarket trials were either late or unfiled in fiscal 2020. Read More
Even in 2022, overly stringent eligibility criteria remain a serious hurdle to making oncology trials representative of the U.S. population. Some diseases, such as diabetes, hepatitis C, HIV or AIDS, that may be more prevalent in underrepresented populations but are in fact quite manageable, need to be dropped from eligibility criteria, experts say. Read More
