Professional relationships with physicians are extremely important sources of collaboration for device companies. Physicians provide technical input, identify unmet needs, and perhaps most critically, conduct clinical trial administration and oversight. But investigators from the Office of Inspector General and Department of Justice have targeting these relationships for special scrutiny, and FDA is tightening requirements for product approval.1 Therefore the need for high quality clinical collaboration has become critical for stakeholders. The growing corporate challenge is to mitigate compliance risk, and to ensure that increased enforcement scrutiny, disclosure requirements, and procedural safeguards don’t alienate these valuable resources.
The answer to this challenge is to reassess the process of selecting professional partners to ensure that value is clearly and transparently at the center of such professional exchanges. Taking this approach not only minimizes compliance liability, it also improves outcomes by focusing on the match between task requirements and partner capabilities. This article examines clinical trial administration to demonstrate factors that make for an effective physician collaborator.
Traditionally, sponsors have chosen investigators for a variety of reasons, including the investigtor’s reputation or position as a key opinion leader or the investigator’s profile as a public speaker. Having an opinion leader involved in a clinical trial may have its benefits, but as scrutiny and demands for transparency increase, sponsors need to choose clinical investigators based on factors that demonstrably add value to the research enterprise.
Recognizing Value in Clinical Researchers
|Michael N. Abrams
A study conducted by the FDA Division of Bioresearch Monitoring (BIMO) highlights desirable qualities of a clinical investigator.2 The study analyzed the characteristics of medical device clinical investigators whose study sites were judged, in FDA inspection, to be entirely compliant with applicable regulations. The authors found some significant statistics regarding these investigators, as follows:
- 62% were in cities with population less than 500,000.
- 2/3 of clinical investigators had prior FDA inspectional experience.
- 80% had prior experience conducting FDA-regulated clinical studies.
Not surprisingly, the study supports the general conclusion that research experience is important. The authors acknowledged, however, that they expected to find a higher percentage of compliant clinical investigators in large metropolitan areas that are more likely to have state-of-the-art hospitals, academic institutions, and research centers. The also expected a higher level of sophisticated institutional review boards, and larger research populations. The findings of the study, however, did not support these hypotheses. Not only were a majority of sites with successful device investigators in cities with a population of less than 500,000, but many were in cities of less than 100,000.
Most importantly, this study and others also concluded that availability of a well-trained and experienced study site staff may be more critical than the total number of staff at a site, and that staff turnover rate may be more important than staff size.3,4 Besides staff and investigator experience, interviews with sponsors, investigators, administrators, and study coordinators all suggest that investigator commitment to research was a critical factor.
Building Value into Professional Relationships
As transparency demands increase, sponsors need to demonstrate that selection of an investigator is based on factors directly related to the research. One way to build value into these processes is to create a structured framework for engaging clinical researchers. The framework should serve as a screen to address conflicts of interest, ensure a focus on the company’s legitimate business need, and the professional’s demonstrated ability to fill it. It should also ensure that fees are appropriate for the services provided. The potential benefits of such a framework are an increased likelihood of developing high-quality research results, fewer problems from FDA or other investigators, and reduced compliance risks.
The framework should take into account necessary study activities and base investigator selection on relevant professional qualifications. That way, sponsors can build professional relationships based on real value. Physician investigators can be chosen on their career stage, practice type, and skill set. Although all investigators must commit to following GCP guidelines, the point is to identify study-specific strengths. Does a potential investigator have knowledge or experience with the type of product being studied? A physician who has recently entered practice may have fellowship research experience relevant to a new drug or device, unlike an established physician. Does the physician have clinical research experience?
The above BIMO study on characteristics of effective clinical investigators has a number of implications for sponsors to consider when choosing a physician collaborator. One is that sponsors need to know a great deal about a prospective investigator’s staff, as well as the investigator. In fact, sponsors may want to keep in mind that they are choosing a study coordinator and office resources, and not just an investigator. Sponsors also need to look beyond organizational resources to the physician’s motivation. Besides staff or investigator experience, the BIMO study found that demonstrated investigator commitment to research was critical for success.
A well-trained and experienced study coordinator and site staff can be critical to the outcome of a study. Is the physician part of a practice that has the resources to support clinical research? Identifying a physician with a strong interest in research—and the willingness to commit the necessary resources—can be as valuable as experience, and more valuable than an experienced investigator with a poor compliance record. Is the physician in a location that provides geographic and patient diversity and balance? Is the patient population in the physician’s practice appropriate and large enough to be a study site?
A structured selection framework should also ensure that compensation of selected partners is clearly related to the match between their qualifications and the requirements of the study. Investigators chosen based on qualifications relevant to a particular study should be paid an appropriate, fair market value fee for their services. Device companies often underpay for conducting clinical research. Companies need to recognize the time and effort involved in conducting research and the benefit of working with committed, professional researchers. These relationships place importance on high quality data, not just on meeting or speaking time. Companies should develop FMV ((AU: Please define)) fee ranges to reflect variables such as experience, project complexity, performance impact, as well as relevant professional qualifications and skills, and consider the business value of the service provided. This approach helps ensure consultant compensation practices reflect consistency and market appropriateness in light of the type and value of the consultant services provided.
Sponsors need quality data from their clinical research. Although site monitoring helps ensure a study progresses according to the protocol and follows GCP requirements, choosing appropriately qualified investigators is one the most important factors, and the conventional wisdom in this area is not always accurate. Finally, such a framework for selection can be adapted to use with investigator initiated studies that further a company’s legitimate business goals. The following seps should be taken:
- Choose investigators based on qualifications relevant to the study, commitment to conducting research, and staff and site resources that support conducting high quality research.
- Screen for potential conflicts of interest.
- Determine and pay fair market value fees for investigator services that reflect the specific match between their skill set and characteristics, and the requirements of the study.
Putting value at the center of partnerships with healthcare professionals means paying more attention to identifying value-added skill sets and characteristics, going beyond conventional wisdom, and customizing decision making to the specific situation. Using an appropriately structured framework enables companies to base professional relationships on real value. This approach provides transparency by establishing a basis for valuing and managing a business relationship, addresses COI concerns, and helps provide quality data. Such an approach helps to ensure both quality outcomes and compliance.
3. Davis, Arlene M., Hull, Sarah Chandros, Grady, Christine, Wilfond, Benjamin S., & Henderson, Gail E. (2002). “The Invisible Hand in Clinical Research: The Study Coordinator’s Critical Role in Human Subjects Protection,” Journal of Law, Medicine, & Ethics, 30 (3), 411-419.
4. U.S. Department of Health and Human Services, Office of the Inspector General, Food and Drug Administration's Oversight of Clinical Trials (Washington, D.C.: September 2007).
Stephen E. Rothenberg, J.D. is a business analyst and Michael N. Abrams, M.A. is the managing partner at Numerof & Associates Inc. (NAI). For more information, visit www.nai-consulting.com. Numerof can be reached via email at [email protected] or by phone 314-997-1587.