Out-of-hour procedures for clinical trials
pharmafile | December 8, 2010 | Feature | Research and Development | GCP, Good Clinical Practice, Guy’s and St Thomas’ NHS Foundation Trust, Katherine Kennedy, clinical trials, trial safety
When a clinical trial subject is involved in a medical emergency, the hospital team need rapid access to information about the trial and the Investigational Medicinal Product (IMP), and may also need to unblind the treatment allocation.
The regulations governing the conduct of clinical trials require that sponsors should have a system in place to deal with enquiries outside normal working hours, but they do not specify how this should be arranged. Similarly, the regulatory inspectorate will want to see evidence of an effective service, but regard the specific arrangements as a ‘business decision’ for each sponsor.
For many sponsors, maintaining adequate out-of-hours cover is a challenge, and because the volume of enquiries is low, weaknesses and inadequacies in the arrangements can easily go undetected. Common major findings during Good Clinical Practice (GCP) inspections include:
• No clear out-of-hours emergency procedures
• Failure to test these procedures
• Failure to supply trial subjects with emergency contact details.
For over 20 years Emergency Scientific and Medical Services (eSMS) have provided an emergency telephone response service on behalf of clinical trial sponsors. Emergency unblinding, medical support and medical information are available within minutes 24 hours a day, and all enquiries are answered by experienced office-based staff with expertise in handling complex medical emergency enquiries.
Patient safety is paramount and resonates throughout the service, which is part of the Guy’s and St Thomas’ NHS Foundation Trust.
Providing information to support medical treatment of trial participants is not simply about being able to ‘unblind’ a patient rapidly. In reality, most emergency situations triggering enquiries to a sponsor’s emergency contact number do not require a ‘code break’. Information about the possible treatment allocations is often sufficient enough to enable the doctor to decide how to treat the patient, or whether to discontinue the study drug.
So what arrangements do sponsors need to have in place 24 hours a day, 365 days a year to provide optimum continuity of care for trial participants – and to support physicians who know nothing about the trial or IMP?
The patient card
The patient card may be the only information available to the medical team in an emergency. Subjects may not have their medication with them and may be unconscious or otherwise unable to provide vital details about the trial.
The details provided on the patient card should be carefully considered, for example if medication packs are crucial to unblinding is this information available on the card?
If pack numbers change throughout the trial how is this information captured on the card?
Documented procedures
Arrangements for ensuring that all out-of-hours medical enquiries, including unblinding requests, are dealt with appropriately and promptly should be clearly set out in a Standard Operating Procedure and circulated to all staff involved in maintaining those arrangements.
Accessible 24 hours a day, 365 days a year
All staff on the ‘Emergency Contact’ rota must be fully aware of their responsibilities and the importance of providing a prompt, round-the-clock response to medical emergencies and other urgent requests for information.
Ideally emergency enquiries should obtain an immediate response. Systems that rely on multiple cascades, call-back services or non-specialist routing services can introduce delay and compromise safety, so are best avoided.
Ensure that the on-call staff have 24 hour access to the trial information.
If randomisation information is held on-site how will on-call staff access it out-of-hours? How long are their journey times? Are site security staff aware that on-call staff may need out-of-hours access? Will they need to be escorted? Do they know the alarm codes?
Functionality; tried and tested
Formal testing should be carried out to provide evidence that an emergency response is always available.
A recorded telephone landline offers the most robust option for access by enquirers.
Adequate contingency planning to maintain the function of the service in an extraordinary circumstance should be evident. Plans should include an option to divert calls from the landline to a mobile provider in the event of operational problems with the landline.
If emergency contact arrangements rely on mobile telephones, a second network provider should be considered.
All lines should be routinely tested for connectivity and, less frequently, for staff availability.
If study specific information (IB, protocol, etc.) is normally accessed electronically, a print copy should also be available as a back-up.
Alternatively if share-point or stored records are accessed using a laptop, the robustness of the internet connection should be tested and a suitable back-up put in place.
Expertise, experience and training
All staff providing the service must be adequately qualified, trained and experienced.
Up-to-date training records should be available at all times, including job descriptions which include responsibilities relating to the trial.
If you are considering using a routing service: their experience in dealing with medical enquiries and ability to recognise drug names medical and clinical trials terminology; evidence of staff training in GCP and Data Protection.
Reporting, expedited and reconciliation reports
Procedures should be in place to ensure every enquiry is promptly documented and reported to the sponsor.
Reconciliation reporting at the end of every service period is best practice to prevent an unreported code break occurring out-of-hours.
In the case of a death or event with public health consequences is the escalation process clearly defined?
If the wellbeing of the patient is inherent in the service, design regulatory compliance will follow.
Katherine Kennedy is an information scientist at Guy’s and St Thomas’ NHS Foundation Trust.
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