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The pandemic shows what patients and their doctors can contribute to research

April 25, 2022, 3:49 PM UTC
If we make it easier for doctors to enroll patients in trials, administer medications, and gather evidence within their own practice, we can dramatically expand the reach of trials.
Chip Somodevilla—Getty Images

For patients who feel like they’ve reached the end of the road with established treatments, a clinical trial can offer new hope. But getting into a trial can be a real challenge.

Most doctors don’t offer clinical research opportunities to their patients. Even patients in major cities like New York or Los Angeles are unlikely to find that their doctor can offer them a trial. This is particularly true in underserved communities, both urban and rural.

If there’s a silver lining to the COVID-19 pandemic, it’s that we’ve been shown the way to massively expand the speed and reach of clinical trials, to the benefit of so many. By focusing on existing research, enrolling patients quickly, and moving through an expedited review process, the research community was able to test and create vaccines in record time.

Just as we have with COVID-19, we can make a mass scale change in research for patients with intractable health conditions, like cancer, dementia, and liver disease.

The math of the problem

An estimated 72% of Americans live more than a three-hour drive from a doctor running a relevant drug trial. Meanwhile, several studies have shown that fewer than five percent of cancer patients enroll in trials. The numbers are worse for patients with less financial means.

It’s not just today’s patients who suffer. Drug development is getting more expensive. It costs roughly $1 billion and requires seven years to develop a single new drug, with COVID-19 vaccines being an exception on both spend and time to market. Outside of COVID-19, more than 85% of trials fail to meet their enrollment goals on time.

The math for doctors isn’t great either. It can cost hundreds of thousands of dollars, if not millions, to set up strong research capabilities in a private medical practice. Very few doctors have this kind of capital to spare, which is particularly frustrating because research can provide vital revenue for community practices.

The high cost and slow speed of clinical research have led the industry to focus on a relatively small number of drugs with only the highest revenue potential. The results have been fewer drugs being produced, fewer patients being helped, and fewer doctors being able to pursue their goals of offering better care.

The question is why

Community and private practice physicians who see the most patients are generally unable to build the infrastructure they need for trials. Running a modern clinical trial involves dedicated staff, office space, regulatory expertise, business operations, and most importantly, technology.

Major centers like Johns Hopkins University or the Mayo Clinic have the financial wherewithal to maintain drug trial infrastructure and spend. Yet even these storied institutions often fail to meet study enrollment goals.

To be clear, there are some physicians in independent practice doing research. There are also a small number of dedicated research centers. They show what can be done–but they are few and far between. Most doctors with a strong interest in the cutting edge and a commitment to science have simply lacked the capital or infrastructure for operationalizing clinical research.

Bringing the new economy to medical research

There have been many efforts to modernize clinical research. Venture capital has backed lots of companies that market trials to patients. Lots of money has gone into “virtual” trials, in some cases only looking at retrospective data to prove a drug works.

However, the great majority of this investment has overlooked a critical player: the doctor. New sources of capital and new technologies can empower physicians to unlock their untapped capacity for medical research–and create entirely new business models along the way.

This is an opportunity with both altruistic and economic implications. In times of shrinking insurance reimbursement and medical staffing shortages, clinical trials can offer a valuable new revenue stream for community doctors as small business owners. From our experience, pharmaceutical companies offer more than insurance reimbursement for comparable procedures, including incentives for doctors and patients – which are all governed by institutional review boards.

By bringing medical research into community medical practices, patients can receive experimental therapies without the high costs and lost productivity of traveling to a major academic research center. A broader diversity of participants will be able to participate in trials, helping ensure that drugs will be effective and accurate for all types of patients. Trials can also be launched more effectively at the local level for conditions previously neglected by the research community.

If we make it easier for doctors to enroll patients in trials, administer medications, and gather evidence within their own practice, we can expand the reach of trials beyond the ivory tower.

Alexander Saint-Amand is the CEO and co-founder of Topography Health.

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