The FDA is tackling head on the issue of including more older adults in trials and it’s getting mixed messages from the industry, former commissioners and the agency’s own data on how best to address the problem. Read More
Master protocols, having shown their usefulness in COVID-19 and oncology research, are on the rise and expected to expand into other therapeutic areas. But even with the strong backing of regulators, challenges remain for master protocol studies to become more commonplace. Read More
The issue of protocol complexity is receiving increased attention with the release of new data that show dramatic growth in the number of trial endpoints, data points and amendments, and industry stakeholders are mobilizing to adapt management and metrics tools to keep up. Read More
Sponsors have combined data from internal and external sources for years, but the pandemic put their data management strategies on steroids, creating a need to gather, process and interpret data in real time to make informed decisions to keep clinical trials up and running. Read More
Data management professionals at sponsors and CROs say their biggest pain point is pausing trials mid-study for interim assessment or amendments, which typically adds at least a month to the trial timeline. Read More
The percentage of clinical trials that make it through all three phases to win regulatory approval is less than 8 percent over the past decade, leading clinical trial professionals to question whether they should be pulling the plug earlier on struggling trials. Read More
Virtual training for study startup is not only saving time and money, it’s providing more in-depth learning and improved communications between sites and sponsors. Read More
Data, quality and trial management top the list of ways the industry is using artificial intelligence (AI) and machine learning (ML), according to a new survey of the technologies’ impact on clinical trials. Read More
Researchers at the Tufts Center for the Study of Drug Development (CSDD) have developed and tested an algorithm that can calculate a single numerical patient burden score for a clinical protocol. Read More
Sites and sponsors are working toward improving the site qualification process, which is cumbersome, time-consuming and can be costly. Solutions range from data-driven technological tools for sharing information to paring down feasibility processes. Read More