The Demographic, Practice, and Prescribing Characteristics of US Clinical Investigators
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The Demographic, Practice, and Prescribing Characteristics of US Clinical Investigators
Harold E. Glass, PhD Health Policy, University of the Sciences in Philadelphia, Philadelphia, Pennsylvania Daniel P. Beaudry, MBA Business Development, TTC, LLC, Philadelphia, Pennsylvania
Key Words 1572 data; Clinical grant; Clinical trials; Clinical trial agreements; Investigator demographics; Investigator characteristics Correspondence Address Harold E. Glass, PhD, Health Policy, University of the Sciences in Philadelphia, 600 South 43rd Street, Philadelphia, PA 19104 (e-mail: [email protected]).
This article examines the demographic, practice, and prescribing behavior of US principal investigators, especially those conducting outpatient clinical trials. US investigators are predominantly office based but are more likely than the general US physician population to be teaching, conducting research, or working at academic medical centers. When compared with the US physician population, investigators are somewhat older, more likely to be male, prescribe at
INTRODUCTION Improving the rate of drug innovation presents a major challenge for the pharmaceutical industry and health care systems worldwide, with the time required to complete clinical trials representing a major step in this process. Clearly, planning and executing effective, timely clinical trials requires that pharmaceutical companies fully appreciate the available pool of clinical investigators. To date, analysis of the clinical investigators’ pool has been limited; beyond the often conflicting reports based on Food and Drug Administration (FDA) 1572 data. This article represents another step in clarifying the picture by examining the demographic, practice, and prescribing behavior of US principal investigators, especially those conducting outpatient clinical trials. We pay special attention to explaining the difference in profiles of investigators who conduct numerous clinical trials and those who conduct fewer trials. The market for clinical investigators is large; estimates put it in excess of $7 billion (1). Yet only recently has this pool of investigators begun to be appreciated as the major market it is. In the United States, the investigator market functions like many other economic markets; supply and demand play a major role in determining the level of payments individual investigators receive to conduct a specific clinical trial.
levels comparable to their practice peers, and more likely to be board certified. However, there appear to be few demographic, practice, or prescribing differences between physicians who conduct numerous clinical trials and those who conduct few trials. For the many physicians who only participate in one or two clinical trials, the reasons for this limited participation must be due to factors other than these investigators’ demographic, practice and prescribing characteristics.
As demand for a particular type of investigator increases, so does the investigator’s cost per patient clinical trial agreement, widely referred to
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