Research Opportunities for Physician Groups

By Pete Fronte, MBA, President, Altura
and Cindy Giambrone, Pharm. D., Regional Account Scientific Associate Director, Novartis

Many physician groups in California, and around the country, are contemplating options for diversifying services, enhancing revenue, improving physician satisfaction, increasing patient satisfaction and differentiating in the communities they serve. Conducting clinical research and outcomes studies can be an effective option to fulfilling these goals.

Los Angeles based HealthCare Partners is an example of a physician group that benefits from clinical research. The group has a long clinical research history and has conducted over 50 clinical trials since 2000. “By building a clinical research program we were able to leverage our physicians and our patients in a mutually beneficial relationship for the organization, the physician and the patient. All stakeholders are deriving personal and financial benefit with our clinical research program,” say William Chin MD, Executive Medical Director at the group.

Increased R&D spending by industry sponsors (pharma, biotech and medical device) and the NIH is leading to a shortage of qualified research sites and a need for more patient participants. These factors are leading to increased pressure from shareholders and various stakeholders to improve the supply of patients and physicians for studies. An organized effort by physician groups to partner with pharma to develop and execute clinical development and/or health economic study plans can help meet the needs of both organizations.

Physician groups that are seriously considering developing a formal, central strategy and program for research must begin with a fundamental analysis of their internal resources, investment limitations, financial objectives and competing priorities. If a decision is made to proceed, a business plan is suggested as a starting point. The following are types of research and projects physician groups could consider:

Retrospective studies

These studies involve utilizing the group’s databases or patient charts. Most sponsors are seeking an integrated database of encounter, lab, pharmacy and hospital data. Databases are more cost-effective than manual chart reviews and require less time. There are no special requirements except for the availability of data and the ability of the group to extract the data in the format required by the sponsor in a timely fashion. A formal research structure is not required.

Data and Sample Collection Projects

These projects may or may not be part of a formal study. Typically they are prospective in nature and require the collection of data and/or blood samples from patients during their planned physician visit. A formal research structure is not required for these types of projects unless the volume of the projects is high.

Outcomes Studies

These types of studies are prospective in nature and involve a structured protocol that could seek financial, humanistic or medical outcomes of an intervention, medication or medical device. Depending on the volume and complexity of studies conducted, a formal research structure, including trained staff, may be required. Palm Springs based Desert Medical Group provides an example of a physician group that is conducting outcomes studies in conjunction with academic centers and pharmaceutical companies. The academic based studies are focused on interventions, many of which can be carried over to the entire physician base as best practices.

FDA based studies

These studies are required by the FDA for approval of drugs and medical devices. Phase I-III studies are conducted prior to FDA approval of drugs while Phase IV studies are after approval. A formal research structure and dedicated staff is required. One of the challenges for physician group participation is the specificity and intensity of clinical research. While these studies provide reimbursement between $2,000-$10,000 per patient, they are highly regulated with significant consequences for failure to comply with regulations and protocols. Additionally, the safety of study subjects and informed consent process require staff training and effective standard operating procedures.

Entry Options

Many physician groups are indirectly involved with some or all of the research types mentioned above (through a few physicians conducting studies on their own). A more formal approach to any of these types of research will require an entry strategy. Entry options depend on the type of research the physician group plans to conduct.

Do it Yourself

If you have some internal expertise and plan on a relatively low volume of projects, retrospective studies, data and sample collection projects and outcomes studies are conducive to this approach. It is suggested that parameters and objectives are established and that one person is held accountable for oversight and the completion of projects.

Do it yourself with Support

If you are planning on a high volume of retrospective studies, data and sample collection projects and outcomes studies, outside support to create an appropriate structure is recommended. Outside resources could be engaged based on need. Building a reliable structure for FDA studies may require outside support initially and on an on-going basis depending on internal resources and expertise. According to Marc Hoffing MD, Medical Director at Desert Medical Group, "while our research partner provides good outside support building and guiding our research center, a strong internal team is needed to implement the overall research plan and to conduct individual studies on a daily basis. Success does not come overnight so it’s better to have a long-term view for how research can bring value".

Outsource to a Third Party

This option is relevant to building an FDA based research structure. Site Management Organizations (SMOs) can provide selected administrative and operational functions of running a research center at a physician group. The physician groups provide the physicians and the patients. The down side is that SMOs are not physician group savvy as demonstrated by the number of failed collaborations. According to Louis Hogrefe MD, President and Medical Director at Sharp Mission Park, ”SMOs made sense for us as an entry strategy a few years ago because we did not possess the internal intellectual capital. Ultimately the SMO changed hands and we discontinued the relationship. If a physician group is considering the SMO option, a careful analysis of responsibilities, costs, resources provided and potential revenue should be evaluated”.

Conclusion

The common thread among successful physician groups is that research is part of their vision, they have planned for growth and they have appropriately managed their research center’s evolution. The basic elements for all studies are physicians, patients and data. Given the structured environment of physician groups and the abundance of the basic study elements they possess, physician groups provide an attractive option for overcoming the shortage of investigators and patients while meeting their strategic business objectives.

For questions or comments, please e-mail the author at pfronte@altura2000.com