An investigational site trade association called SCRS and a clinical trial site payment and reimbursement vendor called Greenphire tag-teamed on an investigational site survey and recently released the results evidencing the challenges faced by clinical investigational sites around important topics, such as invoicing and reconciliation processes for investigator payments. The pair surveyed nearly 500 investigational sites worldwide and the results showcase the need for what the surveyors claim is “more streamlined payment processes” and what TrialSite News would suggest is a deeper more foundational problem to address.
Only about 3% of U.S. doctors actually participate in clinical research. This limits the number of accessible patients—at least traditionally. Physicians are often hesitant to move into clinical research for a number of reasons but one major one is cost of entry into the world of research. Essentially, a standard clinical practice needs to stand up to a parallel operation with different (and many would say more onerous) processes and systems, not to mention the need for specialized talent which, can be costly depending on what part of the country (or world) the physician operates. Some might say to solve the “physician to investigator” conversion problem and make clinical research a whole lot more robust. But many challenges exist.
Not a New Issue
Traditionally, biopharmaceutical sponsors have sought out investigational sites that not only bring the required therapeutic expertise to bear but also run and maintain operations that support GcP/FDA compliance in addition to having access to the right the right patients in sufficient numbers. In exchange for these services, the industry sponsor offers the protocol, study drug and payment as and when the investigational site executes on the study.
Often, sponsors desired sites that were smaller and easier to work with from the standpoint of budget and contract negotiations as well as their ability to expedite study start-up and achieve key study metrics, such as first-patient-first-visit, in an expedited manner. In many cases, sponsors avoided sites representing larger institutions because they may have more onerous process, including legal times that negotiate more advantage in favor of the site. Many small sites often aren’t that sophisticated in terms of business and legal arrangements and, in many cases, we have spoken with investigators who have signed up for net 90 or even net 180 payment terms—yes that’s right. In this way, the research site can find itself in a cashflow crunch if it doesn’t have a healthy clinical practice to compensate for the lag in payment from the pharmaceutical sponsor.
Enter the Greenphire and SCRS survey. Greenphire is a leading investigator payment technology while SCRS is an association set up to represent investigational sites. A tragic story, the person that founded the organization, Christine Pierre, passed away at age 60 but thankfully the organization is off the ground and a committed team carries on her vision.
The Survey Findings
The Greenphire/SCRS survey resurfaced many well-known topics facing sites—from the length of time to get paid (as we discussed above) to distraction from research activities and the lack of financial predictability. The findings include:
- Over 80% of the site staff surveyed are involved in the invoice process, yet 70% indicated that accounting or finance is not their primary role
- 91% of sites indicated the length of time to get paid by sponsor creates a challenge
- 77% note that reconciling invoiceables is challenging
- 73% feel their current invoicing process is a distraction from their primary research activities
- 70% say that managing pass-through costs is a challenge
- 78% indicate that financial predictability is a challenge with their current processasfs
- 78% indicate that financial predictability is a challenge with their current process
Will Technology & Some Process Solve the Problem?
Naturally, the pair focused the line of questioning in the survey on financials, as a big part of the underlying problem appears to be financial- and processes-related activity. They note in their press release that too many sites are managing complex research operations poorly, via manual processes, spreadsheets and the like. Well, this is true. They continue that sponsors should increasingly offer modern and flexible technology to make it easier for sites—regardless of country, custom, currency or regulatory regime—to conduct business. This payment technology should be configurable with regional options and process adjustments—meaning workflows and other features should be easy to set up and flexible.
TrialSite News supports Greenphire and SCRS position but unfortunately even that wouldn’t be sufficient to solve many of the underlying challenges. That is because many sites just don’t have the sophistication to be able to operate at the scale and levels required of them by sponsors. Moreover, having compelling payment technology doesn’t solve the underlying bargaining challenge that can place small but important sites at a disadvantage.
What else can be Done?
So, big pharma and CROs should undoubtedly heed Greenphire’s word and by all means invest in technologies that make payment processes and exchanges easier and more flexible for the many important small sites out there.
But SCRS should also start thinking about how to further develop site leverage in the marketplace. Perhaps a shared legal service, accessible from a central cloud-based hub, to help the small sites benefit from more bargaining power.
Will New Models have an Impact?
Moreover, new emergent models in clinical research could shake up the established order. New clinical-research-as-care-option enablers emerge, such as Elligo Health Research and others where new organizations bring the technology, process know-how—including GcP compliance—and the interface into CROs while the sites’ physicians and nursing staff do what they are good at—caring for patients. While other clinical-research-as-a-care-option cases find community-level providers up to a regional or national health system, players embracing research as the National Cancer Institute’s NCORP brings advanced cancer care into the community setting.
Vendors such as TriNetX bring an entire network of sites bundled with federated and aggregate data, which when combined and offered in value-added deals to CROs or sponsors makes participating sites more valuable in theory. A resurgence of Site Management Organization (SMO) may raise the bar toward more site level leverage as a recent TrialSite News survey points out. Other far more disruptive elements are emerging, such as 23andMe’s deals removing the traditional site from the traditional equation (essentially selling consumer DNA information directly for pharma to mine and harvest), to all sorts of remote and decentralized, technology-enabled models, such as Science37 with the potential to network multiple sites into an aggregate representative body that could theoretically negotiate based on new value propositions; or for that matter rural networks of practices and sites, such as the type recently organized in the Sierra-Nevada Mountains in California by Dr. Laurence Heifetz—in theory, these digitally-connected networks could bargain as a unit.
Finally, with private equity pouring into investigational sites, more sophisticated operators move in to start maturing the site space in a way that makes sites start to even behave a bit like CROs—offering scale, systems and processes—but of course, in theory, they may command a greater premium including reasonable payment terms. An example of what we label the emerging “Super Sites” could be Velocity Clinical. And, of course, CROs continue to develop and grow internal site networks to become more competitive in that fiercely competitive business—an example would be PPD’s Accelerated Enrollment Solutions.
We applaud Greenphire and SCRS’ efforts to continuously expose these challenges associated with important issues such as payment, but suggest deeper, more foundational challenges need to be addressed so more doctors can practice research in much larger numbers. Interestingly enough, the TrialSite Network now has hundreds of thousands of interested parties around the world, including many tens of thousands of doctors and investigators. Just recently, due to COVID-19, many doctors have approached the online media platform to express their interest in becoming an investigator to combat COVID-19. The interest is there but the matter requires disruptive business models (think Uber) and perhaps some lobbying in Washington DC.