Fraud in Medical Research: An International Survey of Biostatisticians

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Abstract

The characteristics of scientific fraud and its impact on medical research are in general not well known. However, the interest in the phenomenon has increased steadily during the last decade. Biostatisticians routinely work closely with physicians and scientists in many branches of medical research and have therefore unique insight into data. In addition, they have methodological competence to detect fraud and could be expected to have a professional interest in valid results. Biostatisticians therefore are likely to provide reliable information on the characteristics of fraud in medical research. The objective of this survey of biostatisticians, who were members of the International Society for Clinical Biostatistics, was to assess the characteristics of fraud in medical research. The survey was performed between April and July 1998. The participation rate was only 37%. We report the results because a majority (51%) of the participants knew about fraudulent projects, and many did not know whether the organization they work for has a formal system for handling suspected fraud or not. Different forms of fraud (e.g., fabrication and falsification of data, deceptive reporting of results, suppression of data, and deceptive design or analysis) had been observed in fairly similar numbers. We conclude that fraud is not a negligible phenomenon in medical research, and that increased awareness of the forms in which it is expressed seems appropriate. Further research, however, is needed to assess the prevalence of different types of fraud, as well as its impact on the validity of results published in the medical literature. Control Clin Trials 2000;21:415–427

Introduction

The public awareness of scientific fraud has increased remarkably since the late 1980s when a controversy made front-page news, instead a paper investigated for fraud had as coauthor a Nobel laureate [1]. During the 1990s scientific fraud was disclosed on numerous occasions [2]. In fact, it was recently suggested that fraud now is “endemic in many scientific disciplines and in most countries” [3]. However, the clandestine character and consequential lack of reliable information make it difficult to study scientific fraud. The characteristics and frequency of scientific fraud, therefore, are generally unknown, and its impact on medical research is unclear.

Biostatisticians routinely work closely with physicians and scientists in many branches of medical research and have unique insight into data. In addition, they have the methodological competence to detect fraud and could be expected to have a special professional interest in the validity of results. Biostatisticians therefore could provide unique and reliable information on the characteristics of fraud in medical research.

The objective of this study was to assess the characteristics of fraud in medical research by surveying members of the International Society of Clinical Biostatistics (ISCB).

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Material and methods

The ISCB is an international society for biostatisticians, which, in April 1998, had 442 members in 31 countries on six continents. Most of the members (69%) were from the European Union, of whom 80 lived in the United Kingdom, 54 in Germany, and 39 in Sweden. Forty-three members lived in the United States. Eighteen countries had fewer than ten members each (Table 1). The ISCB has a subcommittee on fraud, which was set up following the expression of concerns both about fraud and inappropriate

Results

One hundred sixty-three members and three nonmembers completed questionnaires. We report here information from the 163 members who responded. The response rate for members was 37% (see Table 1). Several responders expressed their concern about anonymity (nationality, age, and sex could identify them). Eleven members also declined to disclose their nationality. Most responders mailed or faxed their questionnaires to the survey office; only 23 (14%) used the Web.

Table 2 shows the distribution of

Discussion

This survey of biostatisticians found that knowledge of fraudulent projects is surprisingly common. Although only 163 of the 442 members (37%) responded to the survey, 81 (51%) reported that they knew of at least one fraudulent project in their proximity in the past 10 years. Even if these 81 responses included all episodes of fraud known to the 442 ISCB members, the prevalence estimate of ISCB members knowing of fraudulent projects in their vicinity in the past 10 years would be 18%. Although

Acknowledgements

The International Society for Clinical Biostatistics (ISCB) covered costs for printing and mailing of the questionnaires of this survey. The full results of the study were presented at the ISCB meeting at Dundee, Scotland, UK, August 24–28, 1998, and are available from the first author. The views expressed in this paper are those of the authors, not necessarily of the organizations with which the authors are affiliated.

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