ISSN:0898-9621    

DOI:10.1080/08989629208573802

出版商:Taylor&Francis Group    

年代:1992

数据来源: Taylor

摘要:

The National Cancer Institute funds and coordinates a large international system of clinical trials, involving many large and small institutions and thousands of patients, which is organized into a dozen cooperative groups. Compliance with the study requirements and data accuracy are monitored at several levels within these collaborative groups. In addition, for approximately 9 years an on‐site data audit process has been conducted by each group. We report the organization and audit methods of one of these groups, the CALGB. In 3 cycles of auditing each CALGB institution, involving over 2300 patients, there have been only 2 instances of scientific improprieties, a rate of only 0.4% in 459 institutional audits. A more worthy result of this on‐site data auditing has been the improvement in compliance with protocol and administrative requirements. Although a system of on‐site reviews of patient records expends both scarce research funds and investigator time, the CALGB has demonstrated the value of such audits for improving the quality of clinical research. The audit system developed by CALGB could be used as a model for others to verify clinical research.

ISSN:0898-9621    

DOI:10.1080/08989629208573803

出版商:Taylor&Francis Group    

年代:1992

数据来源: Taylor

摘要:

This paper is concerned with the use of statistical procedures for testing the reliability of data in the tables and appendices of research reports. A comparison is made between the circumstances faced by quality assurance auditors and those faced by financial statement auditors. This leads to a proposal that quality assurance auditors (1) use statistical procedures which explicitly recognize the risk of not detecting unreliable data, and (2) that such risk be subjectively evaluated in conjunction with other evidence pertaining to the laboratory's compliance with standard operating procedures, FDAGood Laboratory Practices,etc.A distinction is drawn between (1) the above strategy for incorporating statistical evidence into a quality assurance audit, and (2) an alternative strategy based upon an adaptation of theMilitary Standardsapproach to statistical testing. The Military Standards were original set up for continued testing of production lots. Issues are raised about applicability of the latter strategy, and hence the degree of protection provided by it to concerned parties (i.e., both legal and otherwise).The second part of the paper presents the statistical framework of the proposed strategy. While it could be extended to other applications, the focus of the current analysis is on reasonably reliable laboratory environments. Consequently, confirmatory evidence rather than forensic evidence is being sought. It is shown how the research data can be analyzed using statistical samples of varying intensity, depending upon (1) the quality assurance auditor's worst case expectations for individual segments of the data, and (2) the implications of errors in these segments. The procedure focuses on stratified sampling for rare events, an uncharted area of mathematical statistics.

ISSN:0898-9621    

DOI:10.1080/08989629208573804

出版商:Taylor&Francis Group    

年代:1992

数据来源: Taylor

摘要:

The“objectivity”; of leading scientists is examined in light of their citations of other people's work when they are presenting their own work. Can“direct competitors”; be“objective”; in their views regarding historical credits? Can the reward system be influenced by bias citation? In this paper, we have examined the work of Brown and Goldstein on Familial Hypercholesterolemia (FH), which led to their sharing the Nobel Prize in 1985. As an illustrative example of citations, we have analyzed the important contributions of Khachadurian to this work and have looked at how these•contributions were cited by Brown and Goldstein. We show evidence that Khachadurian was a major contributor to the discoveries which led to the diagnosis and mechanism of FH. However, it appears that only part of these discoveries were adequately cited by Brown and Goldstein. Moreover, the part of the work that was not adequately cited by Brown and Goldstein may have contributed to inadequate citation by everyone else in the scientific community. The evidence indicates that Khachadurian's work deserves greater recognition. It is argued that scientists of high moral character and integrity are susceptible to bias when dealing with their own work. It is then argued that prudence suggests that leading scientists who are“direct competitors”; cannot be assumed to be completely“objective”; when presenting their own work.

ISSN:0898-9621    

DOI:10.1080/08989629208573805

出版商:Taylor&Francis Group    

年代:1992

数据来源: Taylor