49 Fraud and Misconduct

in Clinical Research

Jane Barrett

49.1 Introduction

Research misconduct strikes at the very heart of
scientific objectivity. It raises doubts about the
integrity of the science and our trust in the work
of others. We must be able to believe in the relia-
bility of scientific research.
There has been much published on the inci-
dence, detection and prosecution of publication
fraud, rather less on fraud and misconduct in clin-
ical research, but we should be equally concerned
about research fraud. The Consensus Conference
on Misconduct in Biomedical Research convened
by the Faculty of Pharmaceutical Medicine and the
Royal College of Physicians of Edinburgh in 1999
defined research misconduct as ‘behavior by a
researcher, intentional or not, that falls short of
good ethical and scientific standards’. Frank
Wells, co-founder of MedicoLegal Investigations
Ltd., the only specialist research fraud investiga-
tion company in Europe, prefers ‘the generation of
false data with the intention to deceive’.

49.2 How common is research

fraud?

Carelessness is common, research fraud less so, but
botharealmostimpossibletoquantify.TheUSFood

and Drug Administration (FDA) has offered esti-

mates of around 5% of clinical trials. Some autho-

rities suggest a rate of 1%, some up to 7%. My

experience suggests a figure around the 3% mark.

The number of clinical trials running at any one time

must be in the hundreds of thousands, leaving poten-

tialforanunacceptablenumberofstudiesproducing

data that are unreliable or even fabricated. More

than 70% of the audiences of two separate inter-

nationalclinicalresearch conferences withinthelast

two years agreed they had seen clinical research

fraud. Most had done nothing about it.

49.3 Fraud or misconduct?

It is tempting to use the words fraud and miscon-

duct almost interchangeably, but in most cases,

they can be differentiated. In broad terms, research

fraud is defined as wilful behavior that breaches the

principles of good practice in research. Fraud must

have an element of deliberate action: true fraud is

not an accidental act.

The definition of research malpractice provided

by the Wellcome Trust is a useful starting point,

and it makes clear the element of intent:

‘The fabrication, falsification, plagiarism or decep-

tion in proposing, carrying out or reporting results of

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9