Selection Criteria for Phase I Contract Research Organizations by Pharmaceutical Companies
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Drug Information J o u m l , Vol. 32, pp. 825-830. 1998 F’rinted in the USA. All rights reserved.
SELECTION CRITERIA FOR PHASE I CONTRACT RESEARCH ORGANIZATIONS BY PHARMACEUTICAL COMPANIES PIERRE ROSENZWEIG, MD Head, Clinical Development Department, SynthClabo Recherche, Bagneux Cedex, France
The choice of a Phase I contract research organization is clearly a key point for a successful strategy at this early stage of development. A survey was performed with the help of a questionnaire filled in by 36 pharmaceutical companies operating in France and sponsoring Phase I trials. This survey addressed the following main questions: number and type of Phase I studies, information on Phase I centers, and criteria of choice for a Phase I center Finally, the answers were compared to a similar survey performed five years earlier Key Words: Phase I; Contract research organizations; Survey
INTRODUCTION IT WAS ESTIMATED THAT pharmaceutical companies worldwide spend around $30 billion per year on research and development (R&D). Estimations of the percentage of that amount going to contract research organizations (CROs) varies from 10-20% (1,2). In the human pharmacology domain (alias Phase I, nontherapeutic trials), however, the proportion subcontracted may exceed more than 80% of the global workload, especially when the pharmaceutical company is not a major company and/or does not run its own Phase I facility. Morover, there is a global trend within the industry toward downsizing staff and internal expenses and outsourcing, which shifts the workload to the CROs. Therefore, the choice of a CRO appears critical in determining a successful1 strategy at this early stage in R&D.
Identifying, evaluating, and selecting the best CROs for Phase I studies may look in many aspects quite similar to choosing CROs in the latter stages of drug development. There may, however, be some important specific criteria for selecting CROs for Phase I trials. There is apparently a very wide choice of Phase I CROs as more than 200 CROs claim to offer Phase I services, approximately 130 in Europe and 70 in the United States (3). An investigation from the viewpoint of pharmaceutical laboratories operating in France on different aspects of Phase I trials, with some focus on the criteria for choice of CROs was therefore of interest. The secondary objective was to assess any change from a similar survey performed by the same team five years earlier (4).
METHODS Reprint address: Pierre Rosenzweig, MD, Synthtlabo Recherche, Department of Clinical Development, 31 avenue Paul Vaillant Couturier, BP 110, 92225 Bagneux Cedex, France.
A questionnaire including 14 multiple choice questions was sent in 1995 to the head of clinical pharmacology, R&D, or the medical director of all the pharmaceutical companies
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Pierre Rosenzweig
operating in France and conducting Phase I trials. A Phase I trial was defined as a: “nontherapeutic study performed in patients or in healthy
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