The Ultimate Win-Win: Sites Invest, Sponsors Reward

Applied Clinical Trials recently spoke with Jeff Kingsley, DO, founder and CEO of IACT Health, about the importance of increased professional and technology investment at clinical trial sites. Kingsley, a frequent speaker internationally, has been faculty with the Columbus Regional Health Family Medicine Residency as well as director of several academic health system departments.

Q: You’ve recently presented at events on the need to raise the bar for professionalism at the site level. Could you provide a synopsis of your beliefs around this topic?

KINGSLEY: We are performing human clinical research. Certainly nothing to be taken lightly. And yet, presently, there are no rigorous standards surrounding the education and experience needed to be a clinical research coordinator or investigator. There are no minimum criteria. There is no barrier to entry.

For perspective, let’s look backward a few decades in healthcare. There was a time, not so long ago, when, if you wanted to work in the emergency room, or in the intensive care unit, you could. No test. No board certification. Just a willingness and an ability to convince someone else to allow you. But today, there are board certifications and tests that are mandatory to be allowed to work in these areas of a hospital in any large facility. What changed? These are highly complex environments and they are becoming more complicated every moment as we continue to gain advancements in healthcare. There are new treatment guidelines, new therapies, and new procedures to help save lives. And the risk of human morbidity and mortality is very high.

Complexity and risk drive professionalization. Professionalization of any industry is costly. It requires a large investment into the creation of new organizations to monitor the competencies deemed important, to write the tests to assess those competencies, and to police the individuals involved in the delivery of these services. Simple jobs with low risk simply never warrant the investment to “professionalize.” However, complex roles with high risk outcomes do warrant the investment.

Clinical research is complex today and becoming more complex daily. We are writing longer, more convoluted protocols with adaptive designs and complicated randomization schema. Inclusion and exclusion criteria are becoming more intensive. Even unique patient-genetic profiles are now dictating study participation. And, clearly, there is risk of human morbidity and mortality. The discussions around the professionalization of our industry started as a whisper and many said, “no, it will never happen.” But it turned into a conversation and is becoming a movement.

Q: Sites are notoriously known for having to deal with numerous technologies, project management changes, protocol amendments, and other changes from sponsors or CROs, which are outside of their control. How do professionals on the front lines handle these constantly shifting requirements?

KINGSLEY: Standardization improves quality. And, unfortunately, on the front lines, we have anything but standardization. What we work with on the front lines is immense variability. Sites are required to use unique technologies from each sponsor or CRO on each protocol. Many times, we have multiple different technologies being used with the same sponsor. Similarly, sponsor and CRO processes are different among protocols. This variability only increases the likelihood of errors. Airline pilots run through the exact same checklist before every flight because standardization of processes reduces errors. We do the same thing in our operating rooms before, during, and following the surgery. Our hospitals create standardized order sets because everyone agrees that standardization improves outcomes. But in research, sponsors and CROs are driving change, not the sites. If you’re only doing one trial with one sponsor, you’d never see it. But if you’re doing 200 trials with 50+ sponsors and 10+ CROs, the variability is immense.

Q: Can you elaborate on your views around investing in clinical research technology at your organization? Do you believe sites have an obligation to invest in the future of clinical research?

KINGSLEY: In my opinion, the coming professionalization of our industry will mandate that only professional sites can conduct research. Professional sites don’t dabble in research as a hobby. They are dedicated to research as part of their career or as their full career. Those sites must invest in the infrastructure and technology needed to elevate performance in our industry. If the sites drive this investment, the sites will see standardization. Rather than a sponsor or CRO mandating use of their source document templates, delegation of authority logs, or other systems, the sites must invest in their own electronic source and regulatory document platforms and standardize that use across every protocol performed at that site. In so doing, site quality will improve.

However, there is a give and take involved here. Most sites won’t invest in the future of research without an incentive to do so. Today, sponsors don’t give sites better budgets because they’re using eSource or eReg. But, I believe, they should. Site investment into these systems is an investment that produces higher quality data for the sponsor. ALCOA-CCEA (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available) becomes easier. Integration of eSource with EDC is a reality causing seamless data transfer without the delays or transcription errors involved today. There’s good data to show that certified principal investigators paired with certified coordinators produce fewer protocol deviations, enroll higher, and receive fewer FDA 483s. And yet, today, sponsors don’t compensate sites better based upon certifications of the site staff.

The ultimate win for everyone is for sites to invest in infrastructure, technology, certification, and professionalization and for sponsors to reward those sites appropriately in the form of preferred study award and improved contract and budget terms.