A new, detailed template for protocol development is available to sponsors of medical device trials that rely on real-world evidence (RWE). Read More

The number of women who participated in clinical trials that led to FDA drug approvals increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, driven more by an increase in testing drugs specifically aimed at women than gender diversity. Read More

When it comes to deciding how to compensate principal investigators (PIs), sites have three factors to consider and getting them wrong carries a high cost, says one expert. Read More

When developing a plan to gather and analyze vendor performance metrics, the first question to ask is how wide to cast the net for collecting data. Read More

When a site undergoes an FDA inspection, just because its policies and procedures pass muster doesn’t mean the agency won’t ask for more proof of data reliability. Read More

Global trial recruitment rates have been on an upward swing over the past seven years, thanks to new techniques designed to make patient participation easier, but the benefits have not translated to trials’ ability to retain patients. Read More

Studies based on real-world evidence (RWE) don’t have to be a replacement for randomized clinical trials but rather an integral part of an overall trial strategy. Read More

Nearly 30 percent of CROs’ clinical research monitors in the U.S. left their jobs in 2018, a 4 percentage point jump over previous years, according to a new global workforce survey. Read More

The ability of sponsors and CROs to meet the needs of their sites has improved slightly in recent years, according to a new CenterWatch survey, but sites say they need to see more progress in almost all aspects of their working relationships. Read More

For the first time in 22 years, the International Council on Harmonization (ICH) is almost completely overhauling the guideline ICH E8 — General Considerations for Clinical Studies, the international standard for designing and developing trials. Read More