Date: 03 July 2017
A research team which recruited the most patients to a surgery study has received glowing praise from the study sponsor and Contract Research Organisation (CRO).
The Ear, Nose and Throat/Surgery research team at Central Manchester University Hospitals NHS Foundation Trust (CMFT) was among four centres nationally to deliver EARN 4837.
The team worked in collaboration with NIHR Clinical Research Network, Greater Manchester.
It looked at the possible benefit of how a new drug may improve the hearing of patients who have received a cochlear implant.
The study was double-blind, placebo-controlled with a crossover design, meaning that during two dosing windows patients would receive the drug or the placebo.
Each of the fives patient recruited were able to tell when they were receiving the active study drug as they had noticeably improved hearing during this time. This was confirmed by the Research Nurse and Audiologists working on the study.
CMFT did not have the Chief Investigator for the Phase 2 study, but was the best performing site nationally.
The team, based at Manchester Royal Infirmary, recruited five patients. Its target was three to five when recruitment started in June 2016.
During the close-out meeting at the site, representatives from both the sponsor, Autifony Therapeutics, and CRO, SynteractHCR, praised the team for its excellent work, and said they would be delighted to work with CMFT on future studies.
SynteractHCR described working with the CMFT team as "an absolute pleasure".
Bradley Tallon, Senior Clinical Trials Coordinator for Vascular, ENT, Trauma & Orthopaedics in CMFT’s Surgery and MVR Trials Office, said: “The entire team has worked tremendously hard to meet our recruitment target and I would like to thank everyone for their commitment which made us the best performing centre in the country.
“Knowing how much effort has gone into the study at CMFT, it was particularly pleasing to receive such positive feedback from our sponsor and CRO, who were both hugely impressed.
“Having reached this high standard, this should now be the benchmark for Surgery studies going forward and I look forward to working collectively with the team to achieve more successful outcomes.”
The team at CMFT consisted of Principle Investigator Simon Lloyd, Consultant Otologist and Skull Base Surgeon, Emma Stapleton Co-Investigator, Clinical Fellow ENT, Martin O’ Driscoll, Head of Audiology, Unai Estibariz de Martinez, Audiologist, Deborah Mawman, Audiologist, Rojy Santosh, Lead Research Nurse, Bradley Tallon, Senior Clinical Trials Coordinator, Majid Nazir, Clinical Trials Administrator, Jess Nichols, Research Nurse, Jesha Mathews, Research Nurse.
You may also be interested in