Talking Point: Responding to Trial Emergencies
pharmafile | April 6, 2010 | Feature | Research and Development |
Unblinding is only done when it is deemed essential for the patients by the subject’s physician or a regulatory body, and procedures for emergency unblinding should be described in the study protocol or other study documentation.
Trial sponsors must provide 24 hour access for out of hours emergency unblinding, but this can be a challenge for many sponsors.
Arrangements for ensuring 24 hour access need to be reliable and cost effective.
Unblinding is one of the 24 hour telephone support services provided by Guy’s and St Thomas’ Emergency Scientific and Medical Services (eSMS), in addition to emergency medical response, clinical advice and adverse event reporting.
Rita Fitzpatrick, Head of eSMS, says “Clients come to us for a variety of reasons, some struggle to maintain 24 hour availability of staff, particularly clinicians, others just want greater resilience and responsiveness out-of-hours.
“We aim to be flexible and provide support that meets each client’s individual requirements, including short periods of daytime cover for staff meetings or similar circumstances. “Clients find this useful when there are unexpected problems such as the recent heavy snowfalls that made it difficult for their staff to get into work.”
eSMS’s 24 hour capability and experience in providing emergency medical response is unique among providers who offer support for clinical trials.
The information team are on-site 24 hours a day so that they can maintain rapid response times and always have direct and immediate access to all trial documentation and other information resources, whether in hard copy or available online.
The team of medical consultants are on-call and also respond rapidly at any time of day or night.
eSMS was developed 20 years ago by a team of clinicians and information scientists, who had been providing a 24 hour emergency medical information service since 1977.
The service has grown significantly in recent years and now supports approximately 300 trials.
“Most of the studies we support are based in the UK, but several Sponsors based outside the UK who initially approached us about cover for a single UK-based study, have seen the benefit of having the support for the full trial portfolio,” says Rita Fitzpatrick. “Increasingly we are being approached to provide cover for global studies. Guy’s and St Thomas’ NHS Foundation Trust has been working with telephonic interpreting services for many years, so we are confident that we can deal with telephone enquiries from non-English speakers.”
eSMS aims to provide the same high quality of service at all times and with so many different trials to support, staff training is a priority to ensure that the team can locate information rapidly, accurately assess each enquiry, and provide an appropriate response.
Resilience, reliability and continuity planning are key concerns for a service that provides rapid emergency access to information on behalf of clients.
eSMS has contingency plans to ensure normal operation can continue when threatened by staff sickness or travel disruption, or emergencies that require evacuation of the building.
The information team is very proud of its record of uninterrupted operation for more than 30 years.
“For companies who are looking at new ways of using limited resources, outsourcing may be the best way to provide support for some aspects of drug safety.
“eSMS can provide expertise and support that are a cost-effective alternative to on-call rotas and multiple cascade systems” says Fitzpatrick.
At a time when drug safety requirements are increasing across all stages of the product life cycle, eSMS aims to play an increasing role in supporting the pharmaceutical industry in this vital area of drug development.
A REAL LIFE EXAMPLE
In the early hours of a Saturday morning a trial subject presents to A&E with a suspected myocardial infarction.
The A&E registrar needs to know if trial drug interacts with anticoagulant or thrombolytic medications. He telephones the ‘Emergency Contact’ number on the patient card. An eSMS Information Scientist answers the call immediately and within five minutes:
• gives advice on contraindicated medications, from the Investigator’sBrochure
• gives information about treatment options, from the Study Protocol
• confirms that unblinding is not required in this instance, but can be done if the situation changes
An eSMS Medical Consultant contacts the A&E registrar within 15 minutes to discuss further medical management.
Guy’s and St Thomas’ NHS Foundation Trust
Website: www.medtox.co.uk
Contact: esms@gstt.nhs.uk
