Randomized controlled clinical trials are considered the gold standard for understanding treatment safety and efficacy. Rare disease trials struggle to recruit enough participants to demonstrate efficacy, creating a barrier to research and approval. However, Bayesian statistics utilize existing evidence and expert opinion to quantify uncertainty and inform trial design, reducing necessary sample size.
ACRP will incorporate the updated ICH Guideline for Good Clinical Practice E6(R3) into all ACRP Certification examinations within the next two years, based on its final adoption date of January 6, 2025.
A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides. Clinical research associate (CRA) competencies are key to creating and nurturing this relationship under all circumstances.
Although relatively rare, clinical investigator inspections by the U.S. Food and Drug Administration (FDA) can have a significant business impact. Audits are conducted more frequently than regulatory inspections, which are […]
This article presents findings from a survey that was designed to investigate the factors contributing to turnover intentions among clinical research associates (CRAs) within contract research organizations. Previous studies suggest factors associated with high turnover among CRAs include financial compensation, workload, career development, and management, yet little data are available regarding factors influencing turnover post-COVID-19.