Pharma And Physicians – The Key To Successful Clinical Trials
By Mark Vermette, Principal Consultant at Halloran Consulting Group
Traditionally in the pharmaceutical and biotech industry worlds, a pharma company develops a candidate product and then works with a group of doctors to test that product under careful standards and procedures—very much managed by the pharma company. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients.
The roles of the commercial company (the sponsor) and the doctor’s practice were well understood in this scenario, but they have historically created tension. Product companies have had the pressure of proving value and safety and getting the product on the market to recoup their research investments. Doctors’ offices and hospitals have been viewed as inefficient in terms of conducting clinical trials. Medical practices are focused on patient care, and in the past few years, reimbursement for their services. Increased administrative requirements and technology challenges in the healthcare setting have added to the challenges. The resulting stereotypes aren’t necessarily fair, but fairness isn’t top-of-mind when priorities differ so widely.
To alleviate this, there have been a number of efforts to encourage healthcare providers to focus on clinical trials as a care option and address the administrative challenges. Site Management Organizations (SMOs) have sprung up to supplement staff at healthcare practices and integrate systems to make processes more “clinical trial friendly.” These steps and organizations have largely been put in place to help the healthcare provider conform to rules and processes that matter very little to them. However as trends are beginning to show—particularly in oncology and chronic illnesses—we in the pharma and biotech industries have this whole approach and perspective backwards.
Physicians hold the key in clinical trials
Some of the big breakthroughs in the past years reflect a different approach, which should be reviewed and built upon to bridge the cultural gaps between doctors and drug companies. Larger healthcare groups, who run some of the biggest 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. Doctors now see clinical trials as a treatment option for their patients.
Pharmaceutical companies, technology providers, and wiser research organizations like the National Cancer Institute (NCI), have noticed this trend and are leading the charge to change 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.
Despite these complexities, physicians and medical practitioners will continue to hold the keys to unlocking the toughest healthcare problems. They have access to patients and the expertise that comes from seeing and managing health issues day after day. Direct access to patients and experience with specific diseases is key to unlocking our biggest health problems more quickly. The focus of a healthcare provider is not an issue, it’s an advantage.
How pharma companies and physicians can work together
So, what can pharma companies do? I have a few suggestions. First, look at the doctors’ systems currently in use as being 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 the office staff, figure out how to work within the eHR without major functional changes. If eHR adoption is an issue for a practice, help ease their struggles and perhaps invest in improvements. The practice can’t run without it.
Second, invest in the relationship. Pharma, technology providers, and research service companies have spent millions on proprietary systems to support processes that aren’t sensitive to the healthcare practice. Evaluating those investments and redirecting resources towards a solution that works for both the healthcare provider and the drug company could pay major dividends in overcoming inefficiencies in the clinical trial process. There are transparency and compensation rules to consider, but they are in place to keep people honest and protect privacy of patients, not stifle research.
Finally, get creative and invest purposefully in translational medicine. There is tremendous value in the intellectual property being generated at healthcare practices, provider networks, and researchers. For example the NIH published their “Roadmap for Medical Research” in 2008, and a group of research leaders authored an article “Crossing the Chasm: Information Technology to Biomedical Informatics” in 2011 providing a status update and details on the effort. This initiative needs to be updated and adjusted to be more inclusive, with support from all interested parties, industry, and technology providers. Everyone could benefit from a solid business model and investment in this area. The returns would be extraordinary. Everyone wins with a better execution model and data flow.