As the Association of Clinical Research Professionals (ACRP) celebrates its golden anniversary this year, we are pleased to continue our series of Q&A interviews, “Forecasts from the ACRP Fellows: Insights on the Future of Clinical Research as ACRP Turns 50.” Our latest guest is Steven Ziemba, MBA, PhD, CIP, CCRC, CPI, ACRP-PM, FACHE, FACRP.
Q: For 50 years, ACRP’s mission to advance excellence in clinical research has empowered professionals like you to lead the industry forward. What’s a defining moment in your career when you felt proud to contribute to that legacy?
A: I think that would be when I first entered the field. I was previously in biotech and then accepted a position to lead and build a clinical research program for a healthcare system. It provided opportunities to work directly with all facets of the field, and allowed me to even lead some studies. Taking that position was a key point that changed the direction of my career and even the education pathway I was on.
Q: Looking back on your experience in clinical research, what’s a lesson you’ve learned that points to how trials could be improved—whether in quality or efficiency? What changes would help make that improvement a reality, and how might ACRP play a role in supporting it?
A: Listen to the people who report to you. I learned that as I was in a leadership role, I was making decisions that are different from those that the research personnel are engaged in. Consider their feedback in your decisions.
Q: As the clinical research enterprise faces unprecedented challenges like funding pressures, public engagement, and regulatory uncertainty, what’s your outlook on the current state and future prospects of the drug and device development industry?
A: Certain challenges are temporary, such as funding pressures. I think new grant opportunities will eventually present themselves. The real challenge is the pushback against science and the take that one’s opinion is as valid as what facts and evidence show. This is something that seems to have become ingrained in society, and I think will require constant education from the industry to counter this sentiment.
Completely separate is the increasing use of artificial intelligence (AI) in all types of industry, including clinical research. We are only going to see greater use at all stages of how a clinical trial is put together, even from the initial design of the molecule of interest.
Q: Are there any other insights you’d like to share with our readers based on the trends you’ve been witnessing in the trenches in recent years?
A: Clinical research is changing rapidly. AI is only one part of that change, though a big one. Be flexible and learn all aspects of how the drug or device is developed, how the regulations work, and develop an understanding of the scientific process and how it is applied.
About Steven Ziemba, MBA, PhD, CIP, CCRC, CPI, ACRP-PM, FACHE, FACRP
A member of ACRP since 2006, Steven joined the inaugural class of Fellows in 2017. He has served as Chair of the Association Board of Trustees (2016) and of the Academy Board of Trustees (2023 and 2024), among other volunteer positions for ACRP. In addition to other professional activities, he is Founder and Principal, Research Site Consult, LLC and former Associate Director of the Marshfield Clinic Research Foundation. Besides his certifications through ACRP, he has earned a PhD in Healthcare Administration from Capella University; an MS in Biomedical Science from Rutgers University; an MBA in Pharmaceutical Management from Fairleigh Dickinson University; and an MLS in Legal Studies from Northcentral University.
About the ACRP Fellows
Being named a Fellow of the Association of Clinical Research Professionals (FACRP) is a mark of distinction. ACRP’s Fellowship program recognizes those who have made substantial contributions to the Association and the industry at large, as evidenced by: ACRP certification and continuing education, leadership contributions to ACRP, and contributions to the field of clinical research.
Fellowship highlights excellence and commitment to ACRP, and is suitable for only a small, select number of clinical research professionals who are lauded as global leaders.
Edited by Gary Cramer