The rise of the sites

The future of clinical trials

I’ve been involved in over 70 clinical trials, 10M signals, and FDA approvals for drug, device and AI products from customers who are small startups to the world’s largest tech and biotech companies. I’ve had clients with spectacular success and some with bitter failures.

In this essay, I take a step back to think about how we can best bring treatments faster to patients who need them the most.

Today, I had the privilege and pleasure of talking to Kurt Mussina, CEO of Paradigm Clinical Research.   We talked about the challenges and the future of clinical research.

Imagine a future where a handful of large  research sites can find all the patients needed for a study. 

Kurt calls this sea-change -  “The Rise of the Sites”.

Introduction

Historically, clinical research has operated in a unique manner within a highly fragmented marketplace, characterized by its highly complex and disjointed nature. 

Clinical research allocates over $70BN/year to a supplier base that remains astonishingly fragmented. 

How fragmented?

There are over 4,200 Contract Research Organizations (CROs), working with over 10,000 clinical research sites conducting over 450,000 clinical trials for over 30,000 biotech companies.

Conducting a clinical trial requires reaching out to a multitude of sites, sometimes numbering in the hundreds, for larger studies. 

This involves negotiating countless clinical trial agreements, managing budgets, and overseeing a vast network of sites, each demanding meticulous monitoring.

Where other industries, such as logistics and travel, have undergone business process reengineering; clinical research is stuck in 100 year-old processes  and 30-year old software models.

In this essay - we’ll consider an alternative future: the rise to power of research sites.

The Rise of the Sites

Imagine a future where a handful of large sites possess the capability to access the entire spectrum of patients needed for a study. 

In this future, large site organizations would have their own purpose-built technology to seamlessly administer clinical trials, assure patient safety and measure treatment efficacy.

This vision promises a substantial boost in efficiency, one that could revolutionize trial execution and management. 

Sites could potentially disrupt CROs, if they haven't already

I had the privilege and pleasure of talking to Kurt Mussina, CEO of Paradigm Clinical Research.   We talked about the challenges and the future of clinical research.

Kurt brings more than 35 years of international business success to his role at Paradigm, including a record of leadership and achievement structuring and orchestrating global teams in the CRO, CDMO and Clinical Research Site industries. As Paradigm’s CEO, he is responsible for leveraging a scalable business platform on which to continue Paradigm’s profitable growth including the expansion of sites, locations, therapeutic areas, and relationships with leading sponsors, CROs, Principal Investigators and the clinical research community at large.

Before joining Paradigm, Kurt held several executive positions, including most recently as President of Frenova, the contract clinical research services company of Fresenius Medical Care (FMC) while also serving as Senior Vice President in the Global Medical Office of FMC. Under his leadership, Frenova expanded its focus from end-stage renal disease to include the full spectrum of chronic kidney disease and a variety of other conditions associated with renal impairment. Kurt led Frenova to become a network of managed and associated sites including more than 550 principal investigators across 350 research sites in the U.S. He also led Frenova’s global expansion, leveraging an international network of that included over 1,300 clinicians, in 45 countries.

Kurt earned a Bachelor of Science in Chemistry from Montclair State University and received his MBA from Duke University’s Fuqua School of Business.

Kurt - tell me about yourself:

As someone with over 35 years of experience in the field, I've worked in various roles, including CROs. In my view, the spotlight has recently shifted to the sites. When you look at some of the larger sites like Velocity Clinical Research, for instance, they have reached a scale that I discussed with someone this morning. 

They are at a point where they could potentially disrupt CROs, if they haven't already.

Imagine a site business of this magnitude, capable of offering services that have traditionally been in the exclusive domain of CROs but with a more efficient approach, courtesy of their substantial scale and extensive reach into diverse populations eligible for various clinical trials. 

While I don't believe CROs will disappear entirely, I do see site businesses of a certain size encroaching into areas that were once solely the domain of CROs.

I remain optimistic about these developments. 

When we consider the history of relationships between sponsors, sites, and CROs, it becomes evident that there have been some challenges. 

There are individuals within the site community who point out the historical unfair treatment meted out by CROs and sponsors. 

This perspective makes sense, given the highly fragmented nature of the market. 

In response, CROs may have adopted practices that prioritize their interests over those of the sites. 

The lack of bargaining power on the part of sites has been a driving force behind consolidation efforts, which can significantly benefit the sites.

Are CROs sophisticated, well-integrated service organizations?

Danny: Let’s start with a more practical question: do CROs help or hinder sites?

Kurt: Our industry tends to follow certain practices simply because that's how they've always been done. There's a 30% annual turnover in CRAs within CROs, and each time a new CRA is assigned, it places a significant burden on the site. 

Over time, people in the site community have recognized that this burden should not rest solely on the shoulders of the site. 

As a response, we've implemented certain measures, such as charging for re-educating monitors in the case of multiple CRA turnovers.

Regarding the value added by CROs, the original concept emerged long before my 35-year tenure in the industry. 

Pharma companies decided to outsource various aspects of clinical development to CROs, seeking to make their clinical development spending more flexible by delegating these responsibilities. In that sense, there is value in this approach as it brings variability to what would otherwise be a fixed cost for pharma companies.

Danny: On the topic of CROs like IQVIA and PPD, there's often an assumption that these are highly sophisticated and well-integrated service organizations. What’s the reality?

Kurt: The reality can be different. 

The assumption is that when you're dealing with someone at a CRO on a project or budget, they will effectively communicate and coordinate internally.

This is often a far cry from reality, especially concerning financial matters and accountability within the CRO.

Let me share an example. 

We encountered an accounts receivable issue with a CRO in recent months, but no progress was made in resolving it. I decided to take matters into my own hands and reached out directly to the CEO. I made it clear that if we couldn't receive payments according to the agreed-upon terms and conditions, we couldn't continue the partnership. Within a day or two, the issue was resolved, and we established direct contact with their accounts payable department.

I believe that part of the solution to the financial challenges faced by sites, including cash flow and receivables, lies in forming such direct connections. As the site role gains more negotiating power and becomes less consolidated, this dynamic may start to change.

It's essential not to overestimate the sophistication of some CROs in this regard.

Disconnect between clinical tech companies and sites.

Danny: In addition to the disconnect and problems between the sites, sponsors and CROs, there's also a disconnect between clinical tech companies and sites.

It's an elephant in the room, isn’t it?

Kurt: Yes, I'd agree with you on that. I've noticed many comments from people like Brad Hightower and others about the flood of new tech in the industry.   This places a terrible burden on sites, where site coordinators need to deal with 10 different systems and passwords.   

For instance, someone approached me recently with a new CTMS business idea, but it makes me wonder if we really need more CTMS systems. We chose Real Time because it integrated well with our operations, and they came from a site operations background. 

There's so much technology out there, some more mature than others. 

I get calls all the time about new AI-powered solutions that promise to revolutionize patient recruitment and more. 

It's frustrating at times because, as an industry, we tend to chase after the latest shiny objects without considering the negative impact on operational efficiency.

Predicting the future

Danny: Kurt, let’s do something dangerous - predict the future.

What would you like to happen and what do you think will happen?

Kurt: That's a very interesting pair of questions.

What I’d like to happen

I would like to see a continuation of the consolidation in the site world so that sites are put on an equal footing with CROs and sponsors, treated as equals.

I'd like CROs and sponsors to recognize the burdens placed on sites when changes occur at their end, like protocol amendments, which can be disruptive to site operations. What I'd like to see is recognition of that and compensation for it. Sites shouldn't be expected to simply absorb these changes without any compensation.

Danny: Yes, I've seen that too, especially as a tech vendor. Protocol amendments are quite common, and sometimes they happen very early in the study.

Kurt: Exactly. Another significant issue is when sponsors or CROs commit to a study, and sites prepare for it by allocating resources, sometimes even hiring new staff, only to have the study delayed or canceled. This situation can be detrimental to site operations, leading to additional burdens and expenses. Compensation for such situations should be considered.

What I think will happen

Kurt: Well, change won't happen overnight, as this industry tends to be hyper-conservative. 

However, I believe that consolidation among sites will continue due to economic efficiency, reducing inefficiencies. 

While I don't foresee CROs disappearing entirely, I do expect a future where certain services become more site-centric than CRO-centric.

Danny: That makes sense, and it's a realistic perspective. Some have even suggested the ideal future system might involve large, integrated site organizations with their own purpose-built technology to support clinical operations.

Kurt: Exactly. That integration could potentially streamline operations and reduce many of the challenges faced by sites today, creating a more cohesive and efficient system.

I think that kind of future is possible, but it starts with the pharmaceutical sponsors and regulators. 

Large pharma companies often want to do things their own way, which can create a lack of standardization. 

If the pharmaceutical industry, particularly the larger players, can agree on common standards and approaches that benefit all stakeholders, including sites, CROs, and patients, then we can make significant progress. 

Additionally, regulatory bodies like the FDA need to be involved in these discussions because they have a say in how these technologies are used. So, while I hope for a more integrated future, it depends on various factors coming together.

Conclusion

In summary, our journey through the shifting landscape of clinical research has revealed a remarkable transformation. 

This transformation is driven by the rising prominence of clinical research sites, which are poised to disrupt the traditional role of CROs. 

As we continue to navigate these changes, we must address critical issues such as financial challenges, integration within CROs, and the ever-evolving landscape of clinical technology. 

Looking to the future, we have the opportunity to create a more equitable and efficient system by recognizing the value of sites, compensating them for their contributions, and fostering collaboration among all stakeholders. 

The vision of a future where large, integrated site organizations play a central role is within reach, provided that pharmaceutical sponsors, regulatory bodies, and industry players collectively work towards this goal.