Patterns in Prescribing Behavior: The Potential Hidden Costs of Using CROs
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AND NON-tLINItAL DRUG DEVELOPMENT
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Patterns in Prescribing Behavior: The Potential Hidden Costs of Using CROs
"Irotd E* PhD Research Fellow, Center for Evidence-Based Policy, Queen Mav, University of London, London, England, and President, n C , Ilc, Elkins Park, Pennsylvania
Given the important role of contract research organizations (CROs) in conducting market support clinical trials, this analysis sought to answer the question of whether clinical investigators who participate in CRO-run market support studies subsequently prescribe the study drug differently than investigators in studies directly managed sponsor companies. The phase 3b sample of investigator cases consisted of 679 randomly drawn clinical study sites, totaling 450 unique physicians. An additional
Key Words CRO; Clinical trials;
Marketing; Investigator prescribing; Outsourcing Correspondme Address Harold E. Glass, Graduate Program in Pharmaceutical Business, University ofthe Sciences in Philadelphia, 600 South 43* Street, Philadelphia, PA 19104 (e-mail: [email protected]).
INTRODUCTION Clinical trials perform a number of roles in the pharmaceutical industry and CROs play a significant function in conducting these studies for sponsor pharmaceutical companies. Phase 1-3a clinical trials are vital components in dossiers filed with the US. Food and Drug Administration (FDA) to secure regulatory approval for new drugs. In addition, the results from these studies add to the general medical knowledge base, as key results relating to a new drug's safety and efficacy appear in scholarly journals, and are presented at professional meetings. Market support clinical studies, that is, phase 3b and phase 4, often provide information to the medical community on new and marketed drugs, and may be an integral component of a new or existing product's success in the marketplace. Sometimes these market support studies are designed to show no more than that the study drug has a comparable efficacy, safety, or cost effectiveness profile to other important drugs or therapies. Market support studies are often designed though to test whether the drug profiles of a specific drug (or compound in phase 3b) provide competitive marketing advantages for that study drug. In addition, these studies can provide physicians with new or
488 unique physicians, who had been involved as principle investigators at 534 phase 4 clinical trials sites, were randomly selected. Appraximately 75% of the investigators came fiom sponsor company-run clinical trials, with the remaining 25%fiom CRO-run clinical trials. An analysis of covariance indicates that investigators in sponsor company-run clinical trials subsequently prescribe significantly more of the study drug, particularly in phase 3b trials.
added exposure to the study drug, enabling participating physicians to obtain a better understanding of how the study drug works in their specific practice and with their particular patients. Market support studies may provide evidence for a competitive marketing advantage, and equally imp
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