http://bmj.com/cgi/content/full/324/7330/169
BMJ 2002;324:169 ( 19 January )
Letters
Maintaining the integrity of the scientific record
Scientific
standards observed by medical journals can still be improved
New
policy is unlikely to give investigators more control over studies
Scientific standards observed by medical
journals can still be improved
The
average scientific standard of what pharmaceutical sponsors present to
regulators is far superior to that observed by medical journals.1 Despite
laudable efforts recently by various editors in employing
statistical reviewers, much still finds its way into print that is,
essentially, nonsense. If the Medicines Control Agency did its gate
keeping job as badly I would be alarmed.
Despite Smith's comments, ethical standards are often not superior outside
the pharmaceutical industry. During my work for the industry I came
across the following behaviour from the sort of external
investigator that Smith would like the industry to use: the faking
of data; the changing of procedures in the interests of personal
research without approval being sought from either the company or
the ethics committee; and refusal to agree to abide by the
prespecified (and mutually agreed) analysis because this would
jeopardise the possibility of publication.
One example of refusal to abide by the prespecified analysis was
particularly illustrative of the arrogance towards the industry that
may be encountered if one works in it. I was informed that my source
of employment meant that my opinion regarding statistical analysis
carried no weight. (This was a crossover trial, a topic on which I
had written a monograph.)2
A third and academic opinion was insisted on, and when this person,
although chosen by the investigator, agreed with me the investigator
then disagreed with us both. To my then employer's credit, it
refused to be party to the publication that resulted, even though
the results would have been more positive to it than the
prespecified analysis was.
I believe that a much greater improvement in our evidence base would be
obtained if the Medicines Control Agency influenced the standards
observed by medical journals than if the editors of these journals
influenced the regulatory process. My hope for the future is that
sponsors and regulators will move towards publication of regulatory
dossiers on the web. This development should not, of course, be seen
as an attack on journal editors.
Stephen Senn
University College London, London WC1E 6BT stephen@senns.demon.co.uk
Professor Senn is a consultant to the pharmaceutical
industry. This letter represents his personal opinion.
|
1. |
Smith R. Maintaining the integrity of the scientific
record. BMJ 2001; 323: 588 |
|
2. |
Senn S. Cross-over trials in clinical research.
Chichester: Wiley, 1993. |
New policy is
unlikely to give investigators more control over studies
I
have worked in contract research organisations for the past 20 years.
During this time I have worked on many trials designed by these
organisations or by pharmaceutical companies. I have also worked on
some trials in which the investigator was given full control over
the study and its analysis, interpretation, and reporting; the
sponsoring company simply provided funding and technical help. I
have no hesitation in saying that the trials controlled by the
companies are conducted to a far higher scientific standard than
those left in the control of the investigators.1
It would be astonishing if it were otherwise. Most investigators who take
part in these trials are not professional researchers, they are
primarily clinicians. Their training is aimed at treating patients;
if they had any training in research methods it was usually a single
course in statistics in the first or second year of their degree,
before they really appreciated how important rigorous research
methods are in order to do good science.
Pharmaceutical companies and contract research organisations, on the other
hand, have staff whose primary professional skill lies in knowing
how to run a clinical trial efficiently and in such a way that it
gives meaningful and unbiased results. The analysis and
interpretation of data from a major clinical trial take a team of
people many weeks to achieve. It would be impossible for individual
investigators to do this to a satisfactory standard, even given the
appropriate skills, while at the same time juggling with their
primary duties as doctors.
Currently, when the industry publishes its trials it usually does so under
the name of the principal investigator in the belief that this will
help influence medical opinion. Instead of giving investigators
greater control over design, interpretation, and publication, the
effect of the new policy outlined by Smith may well be that more
trials will now be published under the names of the professional
trialists who actually designed and analysed them. This is perhaps a
better way of addressing the criticism that editors and readers are
being deceived.
Dennis O Chanter
Quintiles, Glengorse, Battle, East Sussex TN33 0TX dennis.chanter@quintiles.com
The views expressed in this letter are the author's personal views.
|
1. |
Smith R. Maintaining the integrity of the scientific
record. BMJ 2001; 323: 588 |
|
Related editorials in BMJ:
Maintaining the integrity of the scientific record.
Richard Smith
BMJ 2001 323: 588.
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.