Clinical trials of many new drugs and treatments are flawed and possibly
unethical, a study suggests.
Experts in the United States have found that many researchers fail to
follow international guidelines when they are carrying out studies funded
by the pharmaceutical industry.
They also fail to protect their independence and ensure that their
findings are published, particularly if the results are unfavourable.

It is a worry if a drug company is able to find some way of stopping
publication of the results of a study

|
|
Dr Michael Wilks, BMA
|
Doctors said the discovery raised serious questions about the integrity
of some studies.
They added that it could also stop patients from volunteering to take
part in future trials.
Countrywide survey
Doctors at the Duke Clinical Research Institute surveyed 108 medical
colleges across the US.
Researchers were asked if they followed guidelines issued by the
International Committee of Medical Journal Editors last year.
These guidelines were drawn up by the editors of more than 500 medical
journals across the world and are aimed at ensuring studies are robust and
of a high standard.
However, the study, which was funded by the institute, revealed that
researchers rarely followed the guidelines when they were carrying out
research funded by industry.
Just 1% said they had full access to all of the data from the clinical
trial. The same proportion said they were able to decide when and where
the results of their studies were published.
The survey also showed that many of the contracts between medical
colleges and industry were inadequate.
Dr Kevin Schulman, professor of medicine at Duke University Medical
Center, said the results were surprising.
"We didn't expect to find full compliance with the guidelines but we
were surprised by the extent to which the agreements entered into by
medical schools did not protect the independence of investigators in
clinical studies and the integrity of their research."
But he added: "This is the first study to look at compliance with the
new ICMJE guidelines so we hope it will offer medical schools a road map
for how they might improve their agreements with industry sponsors."
Warning
However, Dr Jeremy Sugarman, director of the Center for the Study of
Medical Ethics and Humanities at the university, warned that patients
could stop volunteering to take part in clinical trials if researchers
failed to strengthen their procedures.
"Patients often participate in clinical trials not only for personal
benefit, but also because they believe they are contributing to scientific
knowledge as a whole.
"If trial data are not made available to others, this may break an
implicit promise to research participants that their contributions will be
used in such a way."
Dr Michael Wilks, chairman of the British Medical Association's medical
ethics committee, said the findings were worrying.
"It is a worry if a drug company is able to find some way of stopping
publication of the results of a study which is not favourable to its
product."
But he added: "It is different in the UK. Studies are approved by
research ethic committees before they can go ahead and I don't think there
would ever be a case where they would allow a study to proceed if there
was a chance that the drug company could prevent publication of the
findings."
The study is published in the New England Journal of Medicine.