The Role and Responsibilities of the Investigator in Ensuring Quality Laboratory Data
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Drug Information Joumnl. Vol. 31, pp. 723-727. 1997 F’rinted in the USA. All rights reserved.
THE ROLE AND RESPONSIBILITIES OF THE INVESTIGATOR IN ENSURING QUALITY LABORATORY DATA SAMANTHA OWEN,BSc, PHD Assistant Director Virology, Quintiles S.A., Lingolsheim, France
Due to the importance of laboratory analyses in clinical studies, whether for toxicity monitoring, assessment of plasma levels, or eficacy assessments, a suitable infrastructure should be created at the investigational site to ensure adherence to the specified protocol requirements for these laboratory parameters. This will ensure meaningful and quality data at the end of the study. Thus, there are certain requirements to consider when selecting investigational sites such as feasibility, equipment, expertise, and personnel. This article will discuss the ways in which a sponsor can develop this infrastructure, the role and responsibilities of the investigator, and the means of maintaining the infrastructure. Key Words: Laboratory data; Specimen collection; Specimen identification; Shipment; Analysis
endpoints and may, therefore, be used to prove the effectiveness of an NCE in the LABORATORY DATA FORM both a funda- Food and Drug Administration (FDA) accelmental and key part of regulatory submis- erated approval procedure for diseases that sions in new drug applications. Laboratory are serious and life-threatening. Another analyses are crucial in monitoring the possi- common example of a laboratory surrogate ble toxicities of new chemical entities (NCE) endpoint is plasma cholesterol as an indicator as well as in assessment of plasma levels in of the eficacy of cardiovascular NCEs in Phase VII clinical studies. In addition, labo- clinical trials. Laboratory analyses are, thereratory analyses can be used to assess the e f i - fore, important in every phase of an NCE’s cacy of an NCE. For example, in trials for development program and should be given a the treatment of HIV infection the CD4 cell significant proportion of the investigator’s count, which is a surrogate endpoint, is moni- and sponsor’s time to ensure that the final tored throughout the study. Surrogate end- data are accurate and reliable. points can be measured sooner than clinical Laboratory analyses, whether for toxicity monitoring or specialist efficacy parameter measurements, can occur in a variety of sceResented at the DIA Workshop “Quality Issues in Lab- narios; the clinical trial center, that is, hospioratory Data: A Ractical Guide to Building Quality tal laboratory; a core laboratory which perinto Laboratory Data for Registration,” October 17-18, forms specialized tests often on a batched 1995, Copenhagen, Denmark. basis; and finally, a central laboratory. Reprint address: Dr. Samantha Owen, Quintiles S.A., 4. Route de la Riviere, B.P. 306,67382 Tanneries Whichever type of laboratory is used, it is important to install an infrastructure at the Cedex, Lingolsheim, France.
INTRODUCTION
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Samantha Owen
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