Accelerated timelines for clinical trial startup will become more the norm postpandemic, but different types of trials will find success at speed at different kinds of sites. Read More
Clinical trials increasingly are using genetic testing as a tool to identify trial participants, but the addition of that tool comes with some extra tasks and considerations sites and sponsors must prepare for, including a separate and more detailed informed consent process and patient counseling. Read More
In a new guidance released on May 11, the FDA supplements the International Council on Harmonization’s (ICH) E9 guideline on statistical analysis with clarification of how clinical trials should define and analyze a drug’s treatment effect. Read More
New guidance from the EU tells sites and sponsors of medical device trials how to communicate with regulators about trial progress, submit safety reports, request permission for protocol amendments and draft trial summary reports under the new Medical Device Regulation (MDR) scheduled to take effect on May 26. Read More
The FDA said on May 5 that it plans to gradually resume on-site clinical trial inspections beginning in July with the intent to be back to normal operations by September. Read More
