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Letters to the Editor
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Clinical trials
Informing professionals when trials are terminated
From Mrs T. Sargent, MRPharmS, and others
We would like to raise awareness of potential issues arising from the
process employed in termination of the Illuminate clinical trial.
Our trust was notified by a fax to the office of the principal investigator
in the trust on Sunday 3 December 2006. The principal investigator was
on annual leave and fortunately a research nurse found it on Monday 4
December.
Our pharmacy service became aware of the trial termination from an article
in The Sunday Times. Initially on Monday morning, we were unable to contact
the trial sponsor, but we did have telephone conversation with the research
nurse who told us of the receipt of the fax. Later that day we were able
to make contact with the clinical trial sponsor. Our pharmacy service
did not receive any notification of termination direct from the sponsor
except at our instigation. If it had not been for the vigilance of one
of our pharmacists we might have supplied a withdrawn medicine to patients
after the trial had been terminated.
We are concerned that the Illuminate trial sponsor did not see the benefit
of contacting the pharmacy services of the institutes participating in
the trial. Such an undertaking would have immediately guaranteed quarantining
of all the trial stock and enabled each clinical trial pharmacist to
have an informed dialogue with his or her local clinical trial investigator,
trust research personnel and trial participants.
We would hope that all clinical trial sponsors note our concerns and
the potential clinical risk issues raised.
Should the need for an immediate cessation of a clinical trial be required
in the future, then we request that the clinical trial sponsor communicates
direct and immediately with the trial sites’ pharmacy services,
disseminating accurate information on procedures to follow and clinical
risk to participants.
Tenesa Sargent
Pauline Martin
Michael Pettit
Brighton and Sussex University Hospitals NHS Trust
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CHARLES SHEAR, on behalf of the Pfizer torcetrapib team, responds:
The
early termination of a global clinical trial programme, particularly
one
of this scope and size, is never easy or without potential issues.
Your correspondents’ suggested proposal is novel and may have merit.
We believe that, as the programme sponsor, we fulfilled our global obligation
to inform the local principal investigator (or delegate) based on good
clinical practice, as well as the public, promptly. Specific emergency
situations will differ in risk and communication plans should be adapted
accordingly.
Our number one concern was patient safety and making sure patients
stopped taking study medication immediately. We simultaneously used
mass media and investigator
notification by telefax as our communication procedures given the timing
of the decision (weekend) and nature of the risk.
Follow-up, both verbal and written, was transmitted within two days following
the decision to terminate the programme to ensure that every worldwide Illuminate
investigator and subject was informed. |
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The
Pharmaceutical Journal