Work

Data fraud in clinical trials

Year: 2015

Type: article

Abstract: Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality.

Source: Clinical Investigation

DOI: 10.4155/cli.14.116

Authors: Stephen L George, Marc Buyse

Institution: Duke University

Language: English

Topic: Academic integrity and plagiarism

Subfield: Safety Research

Field: Social Sciences

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Cancer Institute