CASE STUDY

Effective management of Russian embargo minimises disruption to studies

Situation
On 28 May 2007 the Russian Federal Customs Service imposed a total ban on the export of all biological samples. This resulted in a potential long term delay in clinical trials –potentially costing sponsor companies vast sums of money as well as a very real and immediate danger to patients enrolled on trials where the results would have been used to gauge patient safety.

Objective
To find a suitable solution to minimise disruption to running trials and to ensure that patient safety –always the single primary concern in any trial –remained assured.

Solution
As soon as ACM-Pivotal learnt of the ban (primary information received from our close ties within Russia; in most cases before the sponsor was aware of the issue), we performed an in-depth analysis of how our running trials could potentially be affected and the impact to patient safety.

Where the trial design permitted, we advised to postpone patient visits and where sample stability and patient safety monitoring permitted, we advised sites to store samples at the appropriate temperature for the interim. Where neither scenario was possible, we sought to identify a suitably accredited laboratory within Russia that we could re-route the samples to. In addition ACM-Pivotal implemented a system for the data capture and transfer of results generated from these third party laboratories, in a central database so as to minimise impact to the data management company/sponsor.

For one sponsor, ACM-Pivotal identified a suitable laboratory in St Petersburg for the re-routing of all samples. We immediately provided investigator sites with updated Laboratory Manuals and Request Forms explaining the change in procedure. As time was of the essence we provided these documents in electronic and hard copy formats and enlisted the aid of the local CRAs (Contract Research Associates; also known as Site Monitors) for immediate distribution. Both English and Russian versions of the documents were provided to any sites that required them. With the assistance of the CRO staff and our selected courier partners, our Project Managers effectively managed the re-routing of samples to this single location.

ACM-Pivotal advised the laboratory on the sample types to be expected and the panel of testing to be performed at each possible visit by providing them with comprehensive instructions and summarized wall charts. All patient reports generated by the laboratory were sent to ACM-Pivotal where the results were entered into a study and laboratory specific database. We specified that a copy of the Request Form be sent together with the results so that any data queries or inconsistencies could be handled directly by our Data Managers.

The data was transferred to the sponsor at regular intervals –as was their preference –with a final clean database being transferred once the ban was lifted.

Benefits
By utilising our experienced team of Project Managers and our close ties with both CROs and courier companies, ACM-Pivotal was able to quickly grasp the implications of the ban, identify a solution and then implement the action plan allowing for no major disruption to any of our running trials.

By selecting a suitable laboratory within Russia, and by managing the conduct of the study logistics, analysis and reporting ourselves, our sponsors enjoyed the benefit of having one less aspect to worry about. ACM-Pivotal’s proactive approach and flexibility allowed for exceptional handling of the situation and solidified relationships with our sponsor companies.

The ban was officially lifted during the week of 18 June 2007 following an agreement made between the Russian Ministry of Health and the Federal Customs Services. All shipments resumed as normal.