ACRP Fellow Encourages Flexibility, Creativity, and Persistence in Research
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 June guest is Robert O’Connor, MS, CCRA, ACRP-CP, 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: A defining moment in my career was my involvement in providing input on the draft for the first Good Clinical Practice (GCP) guideline for global adoption from what was then called the International Conference on Harmonization (ICH) (now known as the International Council for Harmonization). This experience, which I initially perceived as a routine internal request, evolved into a significant contribution to groundbreaking global guidance.
I still remember being asked to contribute to that draft. I assumed it was a normal request from our internal regulatory folks for a clinical perspective on a new Food and Drug Administration (FDA) draft guidance or regulation for the Code of Federal Regulations. In hindsight, I should have appreciated the opportunity for what it was—input into what became ICH E6(R1).
As we all know, the ICH E6(R1) guideline established an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials involving human participants. I can now say I feel great pride in being one of the many professionals who influenced this guidance, which has streamlined our ability to conduct robust scientific research globally while protecting the rights and welfare of our study participants.
My involvement in shaping ICH E6(R1) directly contributed to advancing excellence in clinical research by fostering ethical practices, protecting study participants, and promoting robust scientific research globally. This aligns perfectly with ACRP's mission and vision for clinical research to be performed ethically, responsibly, and professionally everywhere in the world.
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: One of the things that I am passionate about is informed consent and the informed consent process. I recall when I started working as a new professional in clinical research 35 years ago, thinking that informed consent was simply something on a checkbox in the massive list of things involved in study execution. I didn’t have much of an appreciation for how important and how complex the process is. As I matured and experienced more at more research sites, it became obvious to me that the informed consent process was overly complicated and was not truly allowing study participants to give true “informed” consent.
The turning point was when my 10-year-old daughter and I both participated as subjects on two separate clinical trials. To truly appreciate how overly complicated the informed consent process is, simply enroll as a participant in a study yourself, and you will quickly see what I mean. Even as a clinical research professional, I found the massive amount of information presented daunting, with the expectation that I could read, digest, and understand the information and give “informed” consent. Since then, I have worked to improve the process on my studies and coach others to do the same. I think the current changes to the consent process are helping, but we have a way to go to truly improve the process. ACRP has the capacity to improve and influence such processes by providing continuing education and training for clinical research professionals, developing best practices and white papers, continuing to advocate for regulatory changes, and continuing to promote research and collaboration to advance understanding of how the processes can be improved.
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: In my experience, things like this have gone in cycles. I may be a bit optimistic here, but I believe many of these stressors can be overcome using tools and resources we have at our disposal. One of the most promising advancements is the growing use of artificial intelligence (AI) to streamline workflows and optimize various stages of drug and device development. AI can accelerate drug discovery by analyzing vast datasets, identifying potential drug candidates, and predicting their efficacy and safety. It can also improve regulatory submissions and post-approval surveillance, enhancing safety monitoring and real-time decision-making. While AI is a powerful tool, it is crucial to maintain human oversight and ensure that AI augments, rather than replaces, human judgment and creativity in research.
I also believe some of the regulatory changes have been helpful with regard to trying to improve the development and approval processes using Quality by Design (QbD) principles. Regulatory changes, although sometimes a source of uncertainty, have also been instrumental in driving improvements in the development and approval processes. Regulatory bodies are increasingly embracing adaptive frameworks to keep pace with innovation, and there's a push for greater harmonization and transparency globally. For instance, the FDA and European Medicines Agency have established guiding principles for good AI practice to ensure patient safety and regulatory excellence.
While we do have a way to go, one thing has never changed in the industry…that is “constant change.” I believe we will continue to be flexible, creative, and persistent in our passion to deliver excellent data while protecting human subjects. We should keep our chins up, heads down, and continue driving technology and process changes, as well as influencing regulatory directions, as we go forward.
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: One of the things I’ve found interesting lately are the discussions around “research as care.” Having “grown up” in the industry and with the evolution of regulations, it is interesting how there has been a change from the sentiment that “research is NOT treatment/care,” it’s an experiment, to the view that “research is medical care.” I understand the nuances of this as the procedures around the intervention can be considered medical care, with only the experimental/investigational product being the researched portion. I can also understand it when considering Phase IV postmarketing trials. But it does concern me that we may be muddying the waters on “therapeutic misconception,” which many of us have worked so hard to moderate over the years. The core of therapeutic misconception lies in the divergent "cognitive frames" of researchers and participants. Researchers view the trial in the context of scientific design to assess intervention efficacy, while participants often focus on their personal medical problems and expect individualized care.
Ultimately, while the idea of "research as care" might seem appealing in its potential to integrate research more seamlessly into healthcare, it necessitates a heightened awareness of the ethical challenges it presents. Maintaining a clear distinction between the primary purpose of research (generating knowledge) and the primary purpose of clinical care (individualized treatment) remains crucial for protecting research participants and upholding the integrity of the research enterprise. I find this an interesting ethical issue which I am more interested in diving into in the near future.
About Robert O'Connor
An ACRP Fellow since 2018, Rob is a Senior Clinical Scientist at The Procter & Gamble (P&G) Company. He has a BA in Biology from Drew University in New Jersey and an MS in Biology from The University of Cincinnati. Rob worked as a clinical research associate (CRA) at two different contract research organizations before joining P&G in 1994 as a CRA. In his current role, Rob is responsible for protocol development, study design and management, and post-study activities for Pampers diapers and baby wipes. In addition, he is responsible for institutional review board review, FDA compliance, and monitoring of the safety of study subjects. He has served as the principal investigator on more than 50 clinical studies and had his research published in numerous peer-reviewed journals. He spent 10 years teaching in the Clinical Research Certificate program at the University of Cincinnati as an adjunct professor. He started his ACRP journey in 1992, was certified in 1996 (CCRA) and 2018 (ACRP-CP), served as an item writer for the CCRA exam, and served on the CCRA and ACRP-CP exam committees, including time as the chair of both. He is currently the Chair of the ACRP Academy Board of Trustees.
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