Clinical trials data integrity

The Cancer Bioinformatics Infrastructure Objects (caBIO) [16] (http //ncicb.nci.nih. gov/core/caBIO) is the primary architecture for data integration at the National Cancer Institute (NCI). It is based on a data warehouse that is used to integrate several of the NCI data sources. The content of the caBIO data warehouse is refreshed approximately biweekly and consists of variety of National Institutes of Health datasets, including genomic, expression, pathway, and clinical trials data. 

The clinical trial protocol is a detailed written plan that outlines how the study procedures are to be carried out and how the data are to be collected and analyzed. It insures the quality and integrity of the trial, particularly when multiple research sites are participating in data collection (Chow and Liu, 1998). The purposes of the protocol are to outline ... 

Statistics analysis is an integral part of a clinical trial. A clinical trial protocol includes information on statistical parameters that the trial is expected to be based on and methods for the analysis of data. 

Potentially, these data can then be deconvolved into simpler qPCR-based assays that are more amendable to routine clinical use, as in the case of the prognostic assays for breast cancer (35,36). However, as these technologies mature they are being incorporated into an increasing number of clinical trials (for recent reviews, see Refs. 37,38,39). Furthermore, novel clinical trial designs have been proposed that integrate knowledge learned from these platforms as interim endpoints to facilitate more efficient adaptive trials. 

The Food and Drug Administration relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials, and to verily the quality and integrity of data submitted, the FDA s Division of Scientific Investigations (DSI) conducts inspections of clinical investigators study sites. DSI also reviews the records of institutional review boards to be sure they are fulfilling their role in patient protection. 

To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, the FDA performs inspections of clinical trial study sites and anyone involved in the research, says David A. Lepay, M.D., Ph.D., senior advisor for clinical science and director of the FDA s Good Clinical Practice Program. Lepay says that the quality of clinical trials has improved markedly since the agency started inspecting them back in 1977. 

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