HRA Approval in action: First patient and first site recruited in a global study
Published on 29 March 2017
Biotechnology company Amgen was keen to get HRA Approval for an international research study into the effectiveness of a new treatment for patients with aggressive B-cell Non-Hodgkin’s lymphoma.
Amgen wanted to examine the use of a drug delivered intravenously to patients whose cancer has relapsed or is resistant to treatment.
Sarah Durston, Head of Clinical Operations, explained:
“This study is a high priority for Amgen and will be recruiting over 300 seriously ill patients at 145 sites worldwide.”
After quickly gaining HRA Approval, the first study site set up and the first patient recruited were both in the UK. Sarah attributes this success to a combination of Amgen’s proactive study start-up team and the responsiveness of the HRA assessment team.
“We proactively contacted HRA to ask for support because this was the first time we had applied using the new approval process. The HRA team was extremely helpful at explaining what we needed to do, and even came to visit us to go into more detail. We received the initial assessment letter very quickly and this was soon followed by approval,” said Sarah.
“There was initially some confusion over how to manage the Administration of Radioactive Substances Advisory Committee (ARSAC) approval in conjunction with HRA Approval and we fed this back. I have found that the HRA team welcome feedback and are well represented at industry meetings promoting a good understanding among commercial organisations involved in clinical research.
“Overall applying for HRA Approval was a very positive experience and the HRA team has asked for a follow-up meeting to capture all the learning.”
HRA has offered to visit any company that wants to learn more about the approval system and we have already made many visits. We also regularly attend regional fora to speak to non-commercial sponsors and welcome invitations to more meetings.
If you would like to meet the HRA Approval team contact us on: email@example.com