On April 20th, 2018, Tanya Verstak interviewed Guy Iannuzzi regarding his role as a trustee for the ACRP from an industry perspective regarding the need for clinical research certification.
About the interviee:
Guy and Mentus market entrepreneurial and technology based companies and products. Their success is enabled by creative solutions driven by customer-centric strategic positioning. Thirty-five years of marketing around the world in a broad range of technologies and markets have made this the pattern for success for all the agency’s clients.
About the interviewer:
Tanya Verstak moved from the Bay Area to Memphis, TN to work at the Epidemiology Department at St. Jude Children’s Research Hospital three years ago. She then fell in love with clinical trials after working at the University of Tennessee Health Science Center and completing a M.S. in Clinical Research Organization and Management through Drexel University.
Tanya Verstak: You are an Association of Clinical Research Professionals (ACRP) trustee: how did you get involved with this organization?
Guy Iannuzzi: One of my clients is a board member of ACRP and a couple years ago asked me to be a “public member.” There are twelve trustees that run the organization along with the staff. There is always one trustee of the twelve that is called a “public member” who is not a person who runs or works with clinical trials directly. That is my role on the board as a trustee: to provide an industry perspective for the organization. Everyone else within the organization is deeply involved in clinical trials, the management and the maintenance and so on.
But in my case, I am involved with the companies, both the CROs and the sponsor companies that basically fund and need the trials. So my perspective is to look at the industry and speak with that voice…
While ACRP is the largest group in the industry that certifies people who manage and coordinates trials, we only work with a small portion of all the people, the hundreds of thousands of people that are actually involved in clinical trials. One of the things we are working hard on is to raise the standards so that we can train and certify clinical research staff.
The FDA likes this because typically data has shown that when we have highly trained, certified staff that is running the clinical trials, we get better outcomes. I mean we get better trials, period, and that’s everybody’s best interest. Unfortunately, there is a small portion of people that are certified and our role, our mission is to increase that percentage.
You would be surprised how few companies are really on board and how many biotech companies we work with who are running clinical trials are not even aware that ACRP exists and that Clinical Research Coordinators (CRCs) can be certified. They do not know the value of that; it is just shocking.
About seven years ago, I helped create a CRO wing of Biocom, which has over 1000 members from other companies. We have about 120-130 CROs that belong to us, and they did not know who ACRP is. Isn’t that amazing? I would say that only 10% of the membership is certified. And that is a horrible number!
Tanya Verstak: Do you think part of the problem is the price of an ACRP membership?
Guy Iannuzzi: Clinical research is a career path, so certification is something that is important in advancement and growth. It is a major differentiation other than time served working on trials. It costs about $5 a month so the reality is it costs less than a Netflix subscription. If you go to other areas and other industries, certification becomes very, very important but for some reason, people don’t think clinical research certification is as important. Although, we know it is: if you have a staff that is certified managing trials, you will have better trials.
That is not negotiable; it is in everyone’s interest to have better, faster trials, and good outcomes. If you look at the stake, companies are paying hundreds of millions of dollars, if not billions of dollars, trying to get something to market and to develop a product. This is just a rounding error in terms of cost so it is frustrating to me and to all of us in the organization.
People who do know are all on board and are very much on board. We have to be persistent, which is part of my role and part of everybody’s role.
Tanya Verstak: I am so surprised to learn this, when I first wanted to get involved in clinical trials, everyone told me to go on the ACRP website to learn more about them. I am shocked that sponsors do not consider clinical research certification when they are selecting their sites.
Guy Iannuzzi: Sponsors look at clinical trials from a large perspective, they look at stock markets and they look at large clinical sites, they just want to enroll patients in the trial. They are more concerned with site payments. And for CROs, they are just looking for somebody to do the job who served time doing clinical trials. They look at your resume, they look at your CV, but they are just trying to find someone to fill the slot. One more criteria is almost negative to them because it makes it even harder to fill that slot.
So a lot of things, kind of an operational level work against this so we really have to sell the value of competency; we need more managers, we need better managers because we want the trial to work.