Why practices and systems need support to successfully run clinical trials

For community physicians and their employers, conducting clinical trials is notoriously challenging. The expenses and resources involved with either starting or scaling a trials program are immense. This means that even large, well-capitalized organizations can’t make the required investment. This has obvious downstream impacts on patients and their ability to access transformative care.

I’ve seen this challenge firsthand. My mother got sick while I was in college with no definitive diagnosis — trials were her only option and nearly impossible to access. Then while starting and running GLG we saw this problem all the time. Even the most well connected people couldn’t access critical trials – including, unfortunately, our own company’s CFO, who couldn’t access a trial anywhere near New York City, with all of its medical resources.

We started Topography to change this. Our goal is to empower physicians and healthcare systems with the infrastructure and tools they need to build research programs and run clinical trials successfully, at scale, so they can increase access for patients. If we want to make care a reality, we need to address the challenges that these physicians and systems face. It’s not easy – and still a great opportunity.

‍

Establishing trials leadership 

Running successful trials is a steep leadership challenge. Most practices and many systems lack a dedicated general manager for their research programs, which are by definition distinct from other care lines and businesses within the organization.

Research programs are operationally complex, need different technology stacks, require a broad variety of talent, and have their own business development, legal, financial, and compliance requirements. All of this requires experienced general management.

The right external partners can provide strong leadership and fill this management void, especially outside of the largest academic centers. Effective leadership in research comes down to managing the capital that goes into a program, overseeing the operational infrastructure, ensuring performance over time, and making sure research integrates into a systems’ broader goals.

‍

Funding and capital management  

For most practices and systems — even large, specialized practices that are often backed by private equity firms or charitable foundations — establishing a clinical research program involves capital allocation and financial risk. But research is, by definition, not for the vast majority of patients. It has variable revenue and highly variable margins. So research never comes first. 

The upfront costs required to get trials off the ground or scale a program can easily run into the millions or tens of millions. Much of this comes down to the staffing and HR infrastructure required to get trials off the ground. That’s before you get to software, physical infrastructure and regulatory requirements. 

That’s why research leadership isn’t just clinical leadership; research management requires that capital is managed properly.

Identifying the operational needs‍

Practices and systems need extensive operational infrastructure to run trials competently and compliantly. A hospital system likely has advanced operational support of, to name one example, patient outreach before colonoscopies. But research workflows are specific and change with each research study. 

Core operational focus areas include: 

• Operational Management
  • Historically, the absence of dedicated leadership has made it challenging to establish operational models and strong benchmarks for success. Without clear success performance management, it’s extremely hard to track a program’s success across an organization, and make necessary changes to funding and operations. 
    ‍
• Staffing
  • Adequately staffing trials requires recruiting, hiring, and onboarding a range of functions, and ensuring they stay with the practice through to the completion of a trial. This is no easy task — 50% of clinical trial investigators were involved in just one trial between 1999 and 2015, which doesn’t even take into account staffing shortages and shifts over the past few years. At one of the large GI practices we work with, they had just one doctor doing research when they came to us and were struggling to retain the staff needed to conduct trials efficiently. The research program was losing money. Bringing in the expertise needed to solve those staffing issues and retain a team long-term expanded the program and allowed a greater number of doctors within the practice to get involved in trials.
    ‍
• Business Development
  • Trials are only applicable to a minority of patients in any given disease category – whereas insurance is applicable to all patients. Medical systems are burdened first and foremost with payor negotiations. And trial revenue comes from a completely different pipeline. In the US there are over 150,000 registered studies at any given time. This means that there are thousands of possible clinical trials that a practice could choose to target. Identifying and contracting for the right trials requires business development expertise that most practices and even large systems simply don't have otherwise.
    ‍
• Legal & Compliance
  • Running trials requires adherence to a series of operating procedures and compliance practices that go far beyond standard TPO. In addition to patient safety and team requirements, contracting in and out of trials requires an ongoing legal output. When it comes to trials, regulations are understandably strict and fall completely outside much of the standard of care and care management that practices are used to.
    ‍
• Patient Identification, Recruitment and Engagement
  • Identifying and recruiting patients for a clinical trial can be complicated and time consuming for a practice. Technology, especially with the advent of AI, is essential to speeding up the process and driving greater diversity and equity among participants. Keeping patients engaged and motivated throughout a trial requires regular direct communication, information sharing, and an established support system for addressing patient concerns. This engagement also ensures that the data collected is accurate and valuable.

Managing the reputational risks‍

Research is a loss leader that directly impacts the reputation of a practice and its physicians. This is part of what makes research appealing, but also part of why it’s challenging and inherently risky. Conducting research is high-stakes and practices run the risk of negatively impacting their reputation if trials are poorly conducted. That’s why having a team with the right expertise to ensure trials are well-run and conducted with the right operational infrastructure (particularly as it relates to patient safety, legal and compliance) is essential to mitigating the risks and making trials worthwhile. There’s no middle-of-the-road approach to trials: you have to do it well, or not at all. 
‍

The way forward ‍

The depth and scale of the challenges that practices and systems face when it comes to running trails requires full stack solutions that take a thick slice out of the problem. While many point solutions are working to tackle different challenges in clinical research, they don’t address the totality of the operational infrastructure and technology needed to conduct research at scale. 

Research is an incredible opportunity for physicians frustrated by the options currently available for their patients. It’s also potentially a strong addition to a systems’ offering to patients. And most importantly, for the right patients, it’s a new source of care that might be life saving. To increase access and ensure that research can be a sustainable care line for a practice, systems need to approach research understanding its challenges, while appreciating the opportunity.