Further lessons from the TGN1412 tragedyBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38929.647662.80 (Published 03 August 2006) Cite this as: BMJ 2006;333:270
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Dr Goodyear refers to the Ethics and Pharmaceutical Medicine
guidelines published by the Faculty of Pharmaceutical Medicine in his
editorial in the BMJ of August 5th on the TGN1412 clinical trial.
While the Faculty agrees that guidelines are important we would wish
to emphasise that our guidelines were not written to cover all possible
eventualities related to clinical trial design but to remind those
responsible that they should think very carefully about the consequences
of any action before exposing a research subject to risk. The greatest
consideration should go into ensuring that sufficient expertise has been
brought to bear on the question of the study design, for no guidelines can
foresee the potential problems that novel research materials may present.
It is the view of this Faculty that good science is indivisible from
good ethics, and it is the responsibility of the pharmaceutical physician
who is acting as principle investigator to ensure that the safety of the
patient or research subject must always take precedence over any other
interest. The investigator must ensure that appropriate expertise is
sought and incorporated into a clinical trial design before research
subjects are exposed to risk.
This response is submitted on behalf of the Faculty of Pharmaceutical Medicine who are my employers
Competing interests: No competing interests