Sharp has been the clinical trial partner of the University of Edinburgh since 2012, working closely with the teams to manage several long-running trials, including the Fluoxetine Or Control Under Supervision (FOCUS) trial.
Fluoxetine is a selective serotonin reuptake inhibitor or SSRI. This group of drugs alter the levels of chemicals in the brain. They are most often used to treat patients with depression but have other effects on the way the brain works. There is some evidence fluoxetine may speed up and enhance recovery after brain damage.
The FOCUS trial is a randomised controlled trial which aims to find out whether fluoxetine given to people for six months after a stroke improves long-term recovery, even if they do not have depression.
The University of Edinburgh has been running the trial since August 2012, with recruitment closing in March 2017.
The Challenge Identified
As the study was nearing a close the Client determined that several sites which had already ceased patient recruitment had surplus clinical trial stock available. They approached Sharp Clinical for a solution that would allow the product to be redistributed and put to use at alternative sites. The intention was to minimize product waste.
The Sharp Solution
The Sharp project management team devised a strategy whereby Sharp arranged collection of the surplus stock from each of the sites and had it returned to Sharp where it would be collated, inspected and, if deemed suitable for use, returned to usable stock. The client was then able to request shipments from the surplus supplies to be dispatched to sites that needed it.
The Positive Outcome
The client could make full use of all available supplies, right down to the last bottle, with zero wastage. Sharp has been working with this client since 2012 on four different projects. The relationship represents an excellent example of the customer partner collaboration that Sharp strives for and best illustrates our values of partnership and expertise.
The client was delighted with the partnership and Sharp’s involvement in the trial;
“A truly historic week with our last drug pack being dispatched. With Sharp’s help we have managed to ensure we had exactly the drug we needed to the very last pack!
Randomisation closed on the 31st March and the best news is that the trial target has been reached and surpassed so we are all very happy here.
Thank you so much for all your work on FOCUS. It’s been a real team effort and it has been a pleasure working with Sharp.”
The Sharp team responsible for delivering this clinical trial demonstrates the expertise and commitment that Sharp brings to our customers projects, from Quality Assurance to Project Management, in order to deliver the best solution for our client and their patients.
The Patient Impact
In the UK 150,000 people have a new stroke each year, and stroke is the main cause of disability in the community. Although there have been major advances in stroke treatments in the last few years, new treatments are still needed to reduce the long-term physical and emotional problems faced by stroke survivors.
Recovery from stroke can take many weeks or months and involve physiotherapy and other rehabilitation efforts by patient, carers and professionals. The aim of the FOCUS trial is to see if treatment with fluoxetine can speed up the rate of recovery and reduce long-term disability.
Small studies have shown that fluoxetine may have other beneficial effects on the brain, and may even help repair the damage caused by stroke. This may reduce the wide range of physical, psychological and emotional problems that are common after stroke. Much larger trials, such as FOCUS, are needed to confirm whether fluoxetine is beneficial before it can be used in routine care.
For more information on the FOCUS trial, click here.