Inverting the clinical trial/physician relationship: The future (and data) is in the practice

By Mark Vermette

Traditionally, in the pharmaceutical and biotech worlds, a pharma company finds a candidate product and works with a group of doctors to test that product under careful standards and procedures. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients for that purpose.

The roles of the commercial company and the doctor’s practice are well understood in this scenario, but they have always created tension. Product companies have the pressures of recouping their research investments, and doctors’ offices and hospitals are seen as inefficient for the purposes of conducting clinical trials. The resulting stereotypes aren’t necessarily fair, but fairness isn’t always top-of-mind when incentives are slightly different.

To fix this tension, there have been a number of efforts to encourage and enable healthcare providers to think and act more like pharma when it comes to clinical trials. These efforts have included supplementing staff at healthcare practices and providing or integrating systems to make things more “clinical trial friendly”. I’m growing to believe, and trends are beginning to show, that we’ve had this whole thing backwards.

Look at what is really happening and some of the big breakthroughs in the past years. Some of the larger healthcare groups, running some of the largest hospitals in the US, see an astonishing number of patients annually. These patient visits number in the millions. Skilled doctors see patterns in data, illness, and diseases and are using this vantage point to drive research. Practicing physicians involved in research are in the best position to select and perfect the therapies that will work, based on their access to patients and their growing experience.

Wiser research organizations, the National Cancer Institute (NCI), pharmaceutical companies, and even technology providers see this and the ones leading the curve are changing longstanding paradigms. From the vantage point of the healthcare provider, research is one part of what they do. It’s interwoven with a busy schedule of patient visits, procedures, and a complex financial responsibility for billing and business management, made even more difficult by the changing healthcare payer landscape.

All the while, physicians and medical practitioners continue to hold the keys to unlocking the toughest healthcare problems of our time. They have access to patients and the expertise that comes from seeing and managing health issues day after day.

So, what to do? Here are three suggestions.

1. First, look at the doctors’ systems in use as the center of their universe. Electronic health records systems (eHR) are the primary collection tools for doctors to gather patient information. Rather than trying to replace them or shove another system in front of office staff, figure out how to work within the eHR without major functional changes.
2. Second, invest in the relationship. Pharma, technology providers, and research service companies have spent millions on proprietary systems to support processes that aren’t very sensitive to the issues in healthcare practice. Reevaluating even some of that investment and redirecting it could pay major dividends in overcoming the inefficiencies that have been major complaints in the clinical trial process. There are transparency and compensation rules about how this is done, but they are in place to keep people honest, not to stifle research. The returns on these investments will reap dividends.
3. Finally, get creative and more invested in translational medicine. There is tremendous value in the intellectual property being generated in healthcare practices, provider networks, and researchers. The NIH published their “Roadmap for Medical Research” in 2008. In 2011, a group of research leaders authored an article (“Crossing the Chasm: Information Technology to Biomedical Informatics“) providing a status update and details on the effort. This initiative needs to be more inclusive, with buy-in and support from the entire group of interested parties, industry and technology providers included. All parties could benefit from a solid business model and investment in this area. The returns would be extraordinary.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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