Newly released data from a study on the costs and benefits of decentralized trials (DCT) demonstrate in hard numbers that using DCT methods can gain a sponsor or site as much as 25 times the original investment and score performance improvements in several areas. Read More
Among the many voices involved in the ongoing discussion about increasing diversity in clinical trials, one group has received less attention from sponsors, sites and regulators alike: transgender and nonbinary people. More effort needs to go into including these populations, according to one transgender advocate, including staff site training and special accommodations. Read More
Sites may be tempted to take on any trial offered, not wanting to turn away business or offend sponsors, but one site in Watertown, Mass., has discovered that shifting to a smaller-scale approach can pay important dividends. Read More
As the clinical trials industry implements more complex trial designs in the quest to achieve greater speed and efficiency, sites must be nimble enough to take on the retraining and increased protocol amendments that come along with these innovations. Read More
In this second of two parts on the developing participant diversity movement, sponsor, CRO and site representatives discuss the impact of the FDA’s recent draft guidance and the efforts they already are making to increase inclusivity in their trials.Read More
This is the first of two parts on the developing participant diversity movement. In this part, WCG subject matter experts discuss the significance of the recent FDA guidance on trial diversity planning and how sponsors and sites should work together to position their trials and medical products for agency approval. Next week, part two will look at inclusion strategies sponsors and sites already are using.Read More
Despite global recognition that clinical trial populations should match ethnic and racial demographics as closely as possible, a recent analysis shows EU pivotal trials still aren’t up to the mark in fully representing the diverse groups their drugs and therapies are designed to treat. Read More
The clinical trials industry has been encouraged by the historic reduction in trial timelines sites and sponsors were able to achieve during the pandemic, but what factors enabled that accomplishment and can they be replicated in a noncrisis environment, a new analysis asks. Read More
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