Blog

The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct and reporting within the global ecosystem. In recent years, there have been significant changes across trial design, operational approaches, data sources, numbers of regulatory partners involved, technological sophistication, and the underlying infrastructure of medical practice.  

​​Many current trends in clinical research will likely continue regardless of the upcoming change in administration. The need to incorporate​ technology into our clinical trials processes, alongside a continued emphasis on the power of ​AI​, will remain a priority for both FDA and the government in 2025. The agency has repeatedly emphasized a need to move away from paper-based data collection in favor of remote access and more streamlined study processes--all aimed at the larger goal of making trials faster and more cost-efficient. ​​     ​​​  

As Christina Brennan, MD, MBA, CCRC, FACRP, begins her volunteer duties as the 2025 Chair of the ACRP Board of Trustees, she took time to answer some questions about her experience in the clinical research enterprise, some of the challenges and opportunities facing it, and how ACRP can be of service to its members and stakeholders.

While the U.S. Department of Justice continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity (ORI)-Department of Health and Human Services (HHS) recently released its Final Rule on regulations governing Public Health Service Policies on Research Misconduct, which takes effect January 1, 2025. Clearly, the role of compliance in clinical research is a critical area of focus, one with the potential for significant consequences if overlooked or minimized.  

Whether it is a case of early-career love at first sight or an arena that a seasoned job seeker enters for a change of pace after time spent in traditional drug studies, there’s little doubt that specializing in clinical trials of medical devices can be an attractive and rewarding, but very different, rodeo for clinical research professionals to play in.