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Fair and efficient system of investigating alleged misconduct can be devised
| The first 150 words of the full text of this article appear below. |
EDITOR
Only one of the five papers on dealing with research misconduct
in the United Kingdom (that by Riis) mentions the pharmaceutical industry and the national medicines regulatory agencies
and only as an
aside.1 Licences for drugs are granted on studies
conducted by pharmaceutical companies and assessed by the regulators,
so fraud endangers safety.
In the United Kingdom the pharmaceutical industry has been responsible for uncovering misconduct and fraud. The initial evidence is usually obtained by the company's clinical research associates who monitor the centres. Fraud can include falsification of data (even phantom patients) and the ethics review process.
A company loses on average about £650 000 ($1m) a day in delay in
registering a new drug. In addition, conducting a trial to good
clinical practice standards costs about £20 000 ($32 000) a patient.
Thus if a 25-patient study has to be repeated and 100 days are lost a
company can
the MRC's approach An editor's response to fraudsters Deception: difficulties and initiatives Honest advice from Denmark