Clinical Research Presents an Opportunity for Physicians Organizations

By Pete Fronte, MBA, President, Altura

The opportunity for physician organizations and health systems to participate in clinical research and other types of research and analysis, such as outcomes research, pharmacoeconomic studies, registry trials and cost of care studies is greater than ever.

High throughput screening, combinatorial chemistry, genomics and other advances in science are pushing the number of New Molecular Entities (NMEs) studied and approved to new and once considered unreachable levels. The worldwide research and development budget for such studies reached $40 billion in 1998, up 40 percent from 1995, according to industry analysts. This number is expected to reach $50 billion in 2000.

Physician organizations should participate in research programs only after developing a game plan and ensuring complete commitment from management and physicians. Setting up a sound infrastructure will open the group up to a host of health research opportunities. All of this makes sense for patient care and the advancement of medicine.

Why Participate?

Physician organizations are attractive in the clinical research process because they have access to patients and physicians in a concentrated, often controlled environment. Additionally, these organizations offer a continuum of care with patients and the opportunity to expand beyond safety and efficacy studies.

During the next five years, there will be a tremendous opportunity for well-organized, well-structured physician organizations to participate in a variety of research opportunities, said David Abrahmson, MD, senior regional medical director for Merck, the pharmaceutical giant. Not having research experience does not always present a barrier. Sponsors (companies that fund research) look for a large patient base and established infrastructure, including experienced coordinators, when evaluating potential study sites, Dr. Abrahmson added. "Physicians who have a desire can become involved effectively if they are provided the guidance and have the first two ingredients," he said.

Sponsors experience difficulty locating physician organizations with the infrastructure and resources to conduct studies, especially in this turbulent healthcare environment. "We have always had an interest in clinical research, as is exemplified by our efforts in the early 1980s and today," said Robert Margolis, MD, CEO of Healthcare Partners Medical Group. "The challenge is that we need to remain focused on our core competency--delivering care. A question any group should ask is, 'Does research fit into our overall vision and strategy?'" Making money on research projects is not a given, he added.

An obstacle for physician organization participation is the specificity and intensity of clinical research. A full-time staff is required to handle the regulatory work and processing of studies from start to finish. Experienced clinical research coordinators are the backbone of any solid research effort. A nurse or medical assistant trying to complete a study on the side without the required support will not cut it with sponsors and can be an issue if guidelines and regulatory practices are not followed. Sponsor audits are common, and a physician organization cannot rule out an audit by the Food and Drug Administration.

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Managing Resources

Although clinical research may bring additional revenue, the resources required and nature of the business usually mean an extended period to profitability. Any number of factors, such as poor enrollment, poor quality of data, a poor protocol or an inability to start a study quickly, may mean a particular project will not be profitable. This occurs while you are paying qualified individuals to operate the research effort full-time. Because a committed staff is needed to make this work, expect an upfront cost and the need to fund the research unit for a period of time with internal financial resources.

Outsourcing research to third parties is a recent trend among physician organizations, health systems and physicians. Numerous organizations provide a variety of services, from basic consulting to full-service, turnkey infrastructure. Full-service firms, referred to as site management organizations (SMOs) within the research industry, provide physicians organizations with the opportunity to share in the upside while minimizing downside risk and upfront costs. "We are pursuing a collaboration because it makes the most sense," said Louis Hogrefe, MD, medical director and president of Sharp Mission Park Medical Group. "We have pursued various internal options over the years but haven't been able to pull it together from an infrastructure perspective." Research ventures, whether internally or externally managed, will fail without 100 percent physician support, Dr. Hogrefe added.

In addition to the potential financial upside of clinical research, other advantages of participation include:>

  • Presence and reputation in the community for group and physicians
  • Intellectual stimulation for physicians
  • Cost savings for procedures and pharmaceuticals
  • Bridge to outcomes, disease management and other types of research
  • Increased patient follow-up, leading to better compliance
  • Increased patient/member satisfaction
  • Diversification of services

Appropriate diversification of services is essential for the success of any physician organization, said Pat Kapsner, CEO, of Bristol Park Medical Group. "There are a host of diversification strategies that Bristol Park employs, with clinical research being one element," he said. Clinical research is one area in which outsourcing is particularly effective, Kapsner added.

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Keys for Success

Many examples of physician organizations with solid research programs, whether internally or externally managed, exist. The common thread is that clinical research remained part of their vision. Consider the following issues when developing or expanding a clinical research program:

Physician buy-in

Without committed physicians serving as investigators, a research program will not work. It is best to start small by involving the physicians with the most interest. Non-investigator physician referrals and assistance is key.

Administration and management buy-in

More than a few compensation and logistical issues must be resolved. Create a business model if you plan to build it internally. If you are outsourcing, make sure you have picked the right partner and created an environment for the partnership to be successful.

Location

Patient flow and concentration of physicians are important. It is crucial to identify and recruit patients quickly. The research staff must have real time access to patients and physicians. The records and study drug must be on-site.

Staff

The administrative work is daunting. Dedicated staff should handle the regulatory, financials and project management tasks. Qualified CRCs are a must because they help recruit patients and conduct most of the research visits; however, they must have the infrastructure to support the research process.

Partners

When choosing a partner, determine its financial stability, healthcare knowledge and clinical research resources. Do not overlook its understanding of the physician organization environment. A good partner is flexible and will implement good research practices with your group's uniqueness in mind.

Pete Fronte, MBA, is president of Altura, which develops emerging and established healthcare and pharmaceutical-related companies. Altura Strategies works with physician organizations, hospitals, integrated systems and sponsors to develop and enhance research and business practices. He can be reached at (949) 330-6160 or pfronte@altura2000.com.

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