When Are Adaptive Designs Best Suited for Oncology Trials?
Adaptive study designs are best suited for oncology clinical trials when meaningful uncertainty exists and a protocol can prospectively use
Reviews
Types of Audits in Clinical Trials
Clinical trial audits are independent quality assurance evaluations of trial activities, records, systems, facilities, and organizations. The main types include:
Frequently Asked Questions About Investigator-Initiated Trials (IITs)
Investigator-initiated trials (IITs) play a critical role in advancing clinical research by allowing investigators to pursue important scientific questions beyond
2026 DHHS Unified Agenda: Four Areas HRPP and IRB Leaders Should Watch
The U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), released the federal
2026 DHHS Unified Agenda: What Clinical Operations and Study Startup Teams Should Watch
Planned changes outlined in the U.S. federal government’s 2026 Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory
2026 DHHS Unified Agenda: What Clinical Research Leaders Need to Know
On July 3, 2026, the U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget
The Belmont Report Still Shapes How IRBs Protect Human Research Subjects Today
With all the buzz recently on regulatory reform for institutional review boards (IRBs), it’s worth looking back to the foundation
NHSR, Exempt, Expedited, or Full Board? A Plain-Language Guide to Potential Review Pathways
Researchers often want to know early whether a study will be considered Not Human Subjects Research (NHSR), exempt, eligible for
What Is ALCOA+? A Practical Guide for Clinical Research
Clinical research decisions are only as sound as the records supporting them, and that soundness begins with data integrity: the
IRB Reportable Events Checklist
Determining whether an event requires prompt institutional review board (IRB) reporting is an important part of protecting research participants, supporting effective
What Is the Difference Between an SAE, AE, and UADE in Clinical Trials?
Adverse events (AEs) are untoward medical occurrences in participants receiving a study intervention, regardless of whether they’re related to the study. Serious adverse
Advarra AI Council Members Participate in a Panel at Northwestern University to Discuss the Impacts of AI on Biosecurity
What impact will advancements in artificial intelligence (AI) have on national security and global public health issues, particularly when it