Trial experts: ER doctors not always right about when to unblind
Clinical trial participants seeking emergency care – such as after a road traffic accident – pose a problem for Accident & Emergency doctors who do not know what therapies the patients have taken. Physicians need to know that the drugs they prescribe will not interact with the trial therapy.
But trial subjects are generally issued with a card saying only the name of the trial investigator and the anonymised name of an active ingredient, which they may or may not be taking.
Even if A&E [ER] doctors are able to reach trial managers in an emergency, they are not always medically qualified to give clinical advice. Conversely, medical monitors of trials may need to remain blinded and cannot be of use, according to Rita Fitzpatrick, General Manager of UK trial services firm ESMS.
ER docs lack trial know-how
Fitzpatrick’s company provides a telephone service for sponsor companies, bringing together the unblinded trial protocol and doctors who can make a clinical assessment of the patient.
“The doctors have all the documentation from the sponsor, and access to the IRT [Interactive Response Technology] in order to unblind the patient if it is clinically necessary.”
But ideally, ESMS’s doctors can avoid unblinding – and therefore dropping the patient from the trial – by advising the attending doctor about drug interactions without giving them all the details.
“Generally speaking A&E doctors don’t have backgrounds in clinical research – they don’t understand the consequences of unblinding and will say they absolutely need to know what drug the patient is on.
“But if we can give some [general] information about the pharmacology –and tell them they can take such-and-such an antibiotic or painkiller [without giving away the drug’s specifics], it helps everyone.
“It helps the patient, because it probably took them some time to get on the trial, and also the pharmaceutical company; if the trial has been running for some time they will lose a lot of their data.”
Almac collaboration
ESMS has announced a collaboration with UK contract manufacturing organisation (CMO) to offer its emergency response service alongside Almac’s own IRT service, which allows sponsors to manage clinical trials remotely.
“It came to light that these [emergency] queries were coming through to the Almac technical support desk – which is for things like password retrieval,” said Fitzpatrick. “So we thought there was a neat fit between the two organisations to provide this service together.”
ESMS currently works with nine out of the top 20 pharma companies, she told us. The organisation has been running since 1996 out of Guy’s Hospital, London, but spun out into a limited company three years ago.
