As Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, Chief Integration Officer with Centricity Research, settles into her volunteer duties as the 2023 Chair of the Association Board of Trustees (ABoT) for ACRP, she took time to answer some questions about her outlook on the current state of the Association and the clinical research enterprise.
Q: Can you give us the quick highlights along your career roadmap to serving as the 2023 Chair of the ABoT that you believe will help you achieve your goals in this role?
I’ve always appreciated both professional and personal development as indicating a person is a lifelong learner. Whether I’m meeting someone or hiring someone, seeing that they are always striving to learn more and stay current in their industry’s knowledge impresses me. To that end, I became certified as a clinical research coordinator (CCRC) by ACRP in 2010 and then as a principal investigator (CPI) in 2015 after I earned my doctorate. My goal is for everyone in the clinical research industry to recognize ACRP certification as the certification to get. One of the initiatives I loved from a few years ago was creating a credential certification (the ACRP-CP for Certified Professionals) for the amazing individuals who work in departments like regulatory, contracts, finance/budget, and laboratory—and now there’s no reason why anyone with the proper experience and knowledge cannot be certified.
Q: World events have caused a lot of turmoil in the clinical research enterprise in recent years. The workforce has risen to the challenges, but surviving isn’t the same as thriving. What can ACRP do in 2023 to support stability and even growth for its members and other stakeholders as we all try to move beyond the pandemic and into the next “new normal”?
ACRP supports stability and growth for clinical research professionals and our industry through three key areas.
First, ACRP is considered the gold-standard in education, training, and certification for the clinical research profession. Our members—both individual and organizational—trust ACRP’s educational training programs and accredited certifications to ensure clinical research professionals know what they need to know when conducting clinical research studies and trials. It may sound simple, but in a highly regulated industry where guidance from regulatory agencies is ever evolving and where new ways of conducting trials are being introduced, being competent and confident in the ability to execute with excellence matters.
If you zoom out from supporting individuals to supporting the industry, ACRP is leading our profession in the collaborative effort to build the next generation of clinical research professionals through its Partners Advancing the Clinical Research Workforce, our consortium of industry stakeholders who are working together to expand, enhance, and gain industry alignment on the growth, quality, professionalism, diversity, and sustainability of the clinical research workforce. Our industry must come together like it never has before to create stability in the global workforce pipeline. That starts with building awareness of clinical research as a great career, providing access to all who are interested in pursuing the profession, and providing ways to advance careers through myriad professional development opportunities.
Finally, we know that increasing and improving diversity in the industry’s clinical research workforce leads to a more diverse clinical trial participant population. This is critical for addressing the long-recognized concern of under-represented demographic groups in clinical trials. Through ACRP’s Diversity Advisory Council, the Association is actively leading in this area, from crafting responses to U.S. Food and Drug Administration guidelines, to sharing perspectives through thought leadership, to managing ACRP’s robust scholarship program for providing access to training and advancement in education for people of color who are pursuing a career in clinical research.
Q: As someone with in-depth knowledge of how study sites function, given the rise of decentralized clinical trials (DCTs), competition for studies from ever-bigger players in the field, and business pressures on efficiency and thriftiness, can you offer any predictions for this segment of the industry regarding what it will take for today’s newest sites to still be functioning by the close of the 2020s?
Pressures on efficiency and thriftiness are a great incentive for everyone to improve and streamline their processes. I’m not so much predicting that will happen as saying it needs to.
The thriftiness is a real issue, though, because my concern is that money is being spent where it doesn’t need to be, and then withheld from where it is most important. The hardest thing we do is get patients into trials, so being thrifty with high-quality clinical sites is one of the worst ideas for thriftiness. But that’s what I think is happening now, and it’s going to actually waste money as an investigation or product drags on for far too long as sites and sponsors struggle to collect enough data.
Because of the payment contractions to sites and yet the increasing complexity of trials that require significant staffing, I predict that smaller or less sophisticated clinical research sites will need to be acquired by larger networks to stay viable.
Q: There is no wrong answer here—can you share your three best guesses about what the “next big thing” in clinical research will be?
- DCTs will further disrupt our industry. There is no legitimate reason why 50% of current clinical research data can’t be collected directly from the patient in their own home or place of work.
- Machine learning software will assist us with patient recruitment. Various types of machine learning will be able to identify quality patients from large datasets in electronic healthcare records, pharmacy records, insurance records, social media, and more.
- Our industry will further explore creating control arms based upon existing patient data, meaning no patients will need to be enrolled into control arms for studies. This will a) reduce the uncertainty for the patient participant, b) reduce the total number of participants needed, and c) dramatically reduce the cost of the research.
Editor: Gary Cramer