By Jeff Kingsley, CEO, IACT Health
Our industry is unintentionally discouraging clinical research sites from investing in infrastructure. As a generalization, sites have the fewest resources of all the stakeholders involved in the successful execution of a clinical research trial. Most sites are very small and struggle to break even. Most sites have little to no IT infrastructure and can’t afford to build it. Most sites have staffing models where employees and physicians have too many disparate roles and responsibilities without the support or training to be successful. Employees are shared between research and non-research functions. The thin operating margins limit sites’ ability to build a meaningful, robust infrastructure, and this limits sites’ ability to be profitable.
This dynamic fundamentally begins with a lack of site differentiation. Sites struggle to prove to sponsors that they perform better on multiple metrics and, therefore, provide more value than other sites. This performance must be balanced among all the needs of study sponsors (a balanced scorecard). Above-average performance differentiates a site from its peers. Without provable differentiation, sponsors and clinical research organizations (CROs) could view sites as commodities — and commodities always suffer from pricing pressure. Additionally, without provable differentiation, the fair market value (FMV) paradigm makes site budgeting approximate the mean. Clearly, no sponsor wants average sites or average performance on their trials. But, quite literally, our current contract and budget paradigm discourages sites from investing in infrastructure because the site’s customers (sponsors and CROS) are not willing to pay a premium to sites with substantial infrastructure.
A shift away from FMV toward a pay-for-performance model would create a more equitable playing field for sites. This idea is part and parcel with reshaping the overall business and delivery model for clinical trials. It will fuel innovation, improve customer relationships, and create a better patient experience.
Many businesses struggle to find a balance between customer service and profitability. For instance, when you “serve your customer appropriately,” you provide a service at a price your customer is willing to pay and at which the business remains profitable. When you provide additional services that your customer is not willing to pay for, then you are overserving your customer and making your business less healthy. Of course, this is true in all industries. Currently, the life sciences industry is largely unwilling to pay for the full suite of services that it is asking from sites and that is preventing sites from serving our industry in the best way possible.
The Real Needs Of Trial Sponsors
No clinical trial sponsor would consciously choose or incentivize average performance. What clinical trial sponsors need is extraordinary performance, and this means more than just enrolling patients. It’s EQTCS — my balanced scorecard of what our industry wants of sites:
- E equals enrolling at least the promised number of patients.
- Q equals extraordinary levels of quality.
- T equals extraordinary rapid execution on timelines — study startup, first patient enrolled, close to enrollment, query resolution, and database lock.
- CS equals immense levels of customer service.
Extraordinary performance cannot be achieved without substantial infrastructure. Infrastructure requires investment in the form of computer applications and systems, staffing, training, and a commitment from the C-suite and governing boards of directors to keep infrastructure updated.
Technology And Infrastructure Needs Of Sites
Year after year, when the FDA inspects research sites, the most common findings remain the same. We are not getting better. Sites are consistently cited for lack of compliance with the clinical trial protocol, lack of appropriate source documentation, and insufficient regulatory documentation, including informed consent, adverse event, and serious adverse event reporting. Technology and personnel infrastructure investments are necessary to make needed improvements in these areas. The areas ripe for improvement include the following.
1. Electronic source documentation (eSource)
eSource is not source documentation simply in an electronic format. Rather, it is an electronic platform with customized form fields built for the nuances of a very specific research protocol. Let’s first look at the alternative. Most source documentation today is captured on paper. This format makes it easy for well-intentioned investigative staff to make mistakes and reduce quality. These errors easily fall into the two buckets above (“lack of compliance with the clinical trial protocol” and “lack of appropriate source documentation”).
2. Electronic regulatory documentation (eReg)
Similarly, eReg platforms are not meant to increase efficiency (although they do). Their purpose is to improve quality. An appropriate eReg platform ensures that anyone working on the protocol has the right licensure, training, and delegation to perform the desired functions, helping reduce the most common errors in FDA findings.
3. Software to assist in patient identification from electronic health records (EHRs)
These include artificial intelligence, natural language processing, and predictive analytics. EHRs are inefficient databases of valuable information. Much of that information is stored in unstructured fields (free text) and cannot be understood by the software. Additionally, due to inadequate processes and integrations, there is a great deal of information stored in EHRs in the form of images. Lab data, radiology, collaborative physician records, and more are all scanned into the EHR in the form of images. EHR software has no ability to query unstructured fields or images. Process and software improvements exist today to assist in patient acquisition for trial participation.
4. Quality assurance and quality control (QA/QC)
In the age of risk-based monitoring, site-based QA/QC are a must. eSource and eReg software are a must for meaningfully improving on our most common FDA findings. But that software then requires a more robust information technology (IT) infrastructure and QA/QC infrastructure. That means people. Sites must invest in significant QA/QC and IT personnel to ensure the most effective utilization of the eSource, eReg, and machine learning software noted above. The ultimate winners of these investments are the trial sponsors. These technology and infrastructure investments enhance enrollment, improve quality, speed timelines, and reduce the overall cost of R&D.
A Collaborative Win for All
Sites should have the opportunity to invest in the infrastructure that is available today and is needed to consistently perform at levels of quality warranted by human clinical research work.
Technology vendors should be making high-quality products that serve the unique and specific needs of sites. If sites are left behind, then the industry’s inefficiencies will continue to persist.
Sponsors must break from the paradigm of using averages as surrogates for FMV. FMV calculations in human resources, real estate, mergers and acquisitions, and most any other industry are complex, well-thought-through analyses of what is really brought to the table in a negotiation. Certification, experience, use of meaningful technologies, employee characteristics, and more should all be brought into consideration in determining the FMV of our budget negotiations. If sites know they’ll be compensated for their investments, they’ll make the investments. Those investments are the ultimate collaborative win for sites and sponsors alike.
About the Author:
Jeff Kingsley, D.O., MBA, CPI, FACRP, is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices. The companies conduct Phase 1b through 4 research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. Kingsley can be reached at 706-536-6619 and JKingsley@IACTHealth.com.