Community doctors are underrepresented in clinical trials, meaning their patients are too. How can community practices become centers of excellence for research and provide better overall healthcare and treatment opportunities for the patients they serve?
For many doctors, there’s a point in their career where they must make a choice between focusing on research or clinical practice. Research-oriented doctors usually align themselves with large academic centers that have an existing research infrastructure. Meanwhile, community doctors generally dedicate the bulk of their time to seeing patients and running the day-to-day operations of a clinic.
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This divide between doctors dedicated to pure research, usually in an academic setting, and those working in community practices, is one of the factors driving well-known disparities in research.
Community doctors know their local populations and understand their patients’ needs. These doctors – and their patients – can, in theory, provide valuable insight to research studies, but until recently, have lacked any significant way to participate in research. This is a reason why minorities and rural communities are poorly represented in clinical trials.
This challenge affects more than the research itself. Lack of access to clinical trials indirectly lowers the standard of care. It is widely recognized that clinical trials as a care option for patients can improve outcomes on a number of metrics, including patient engagement, satisfaction, and quality of care. A study from the Association of Clinical Research Professionals found that 95% of patients in one trial agreed that adding clinical research improved their overall quality of care. Beyond individual patients, there are community benefits when the drug development process includes data from previously excluded groups. This enables treatments to be customized for community needs in a way that was not possible before.
Given the benefits, doctors want to know how to be great community practitioners and do the vital research needed to improve community health.
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In other words, how is it possible for community practices to become true centers of excellence in their communities?
We took a look at practices that have built great research programs, and found they have a number of factors in common that contribute to their effectiveness. We quantify these below to help community practitioners who are considering building or expanding their research programs.
Start with learning
Since the pandemic, which forced broader adoption of hybrid and virtual trials, many more doctors recognize that they can create a new opportunity for both their patients and their practice. Many community practices have developed new programs since March 2020, and not just in vaccine trials.
But there’s a lot to learn.
One doctor we work with told us: “Our goal is to scale an outstanding research program in our community. My partners and I are thinking about what research can offer to our patients, and feel we are unlocking a new chapter for our practice. As we have moved forward, we have found that there are a lot of aspects to building a research practice that we needed to learn and get help with along the way. We know that a lot can go wrong, and we wanted to make sure that we built our program the right way to start.”
There are real challenges…
A realistic approach will help doctors and their practices succeed. While it may seem that adding a research arm to a medical practice is a simple process, this exercise is more akin to adding a new business unit. The ability to support clinical trials at a community practice is more than qualifying patients for a study. It’s a large investment of both time and capital.
This all points to infrastructure – having the right team and technology in place to be able to track and manage the trials, all the way through to tracking down unbilled receivables. Many practices run into, for example, regulatory trouble because they aren’t using the proper systems to track everything. Many practices have significant challenges with receivables, missing out on potential income. Finally, clinics will hit a wall as they try to scale. Critical team members don’t have unlimited bandwidth for clinical research. Expansion requires additional investment in specialized employees.
Many heads of practice eventually realize the considerable lift that the business side of clinical trials requires. Research infrastructure takes significant capital over a sustained period of time to be successful and net a positive outcome for the business. Studies show that 75% of doctors abandon research after their first study when they go it alone.
…but there’s help out there.
Understanding that you don’t know what you don’t know is the first step. Building a successful research arm is possible, but practices will need to be diligent about identifying the right partner(s). Going it alone, generally, isn’t a recipe for success. Most practices will not be able to make and sustain the investments required to build a program. Identifying the right partners is a critical part of developing a research program.
So what is the right partner and what should they be able to provide? There are a range of options practices will be faced with: consultants, business development partners, technology solutions, and ancillary developers. Any of these should have deep expertise in working with doctors and community practices, coupled with an understanding of the infrastructure and technology needed to underpin a research arm.
It’s important to be aware that there is more to it than winning studies from sponsors. It is very unlikely that a community medical practice has the team, infrastructure and technology to support the full range of needs for research, yet many consultants sell the idea of “We’ll win you studies.” The great majority of research physicians find that they are not able to execute all of the required work, and later find themselves struggling to keep studies going without more support or capital.
A good partner should be able to provide a full scope of requirements to ensure success, an effective variety of technology approaches, and insights on the pros and cons of each option. Further, their support service should consist of not only technology, but an infrastructure of people who can drive the trial selection, patient identification, enrollment, invoicing, and more.
Build enthusiasm in your practice
Finally, success for a research program can also be impacted by buy-in from the practice. Doctors who want to help bring research to their practices and communities can make the case to their colleagues by highlighting benefits for patients. Other benefits, such as the ability to recruit and retain doctors who want to do research, can also persuade potential supporters. And not every physician, or even many, have to serve as clinical investigators. Many can learn to simply refer patients.
As outlined, while we do not believe that building a clinical practice is simple, it is possible and urgently important. Taking a realistic approach, and being open-minded about what you don’t know regarding necessary support to achieve this goal will go a long way. Setting up your community practice to do research while providing excellent care to your patients will take work, but the rewards for your patients and the larger community are worth the effort.
Photo: erhui1979, Getty Images
Alexander Saint-Amand is CEO and Co-Founder of Topography Health. Topography’s mission is to expand patient access to trials by supporting physicians and their teams in clinical research. Alexander was previously CEO and co-founder of GLG, a global research platform with offices through the U.S., Europe and Asia. Topography is backed by A16Z and Bain Capital Ventures.
