Endpoint Adjudication

Achieving diversity, equity, and inclusion in clinical trials is vital for inclusive data, safe treatments, and addressing community-specific needs.

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.

In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.

Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.

Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.

Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.

HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.