STH First Global Site Open and First Global Patient to an Oncology Trial
APHINITY for Industry supports global Sheffield success
Commercial clinical research is a highly competitive environment, so opening the first site and recruiting the first patient to a global study are significant challenges. The Cancer Clinical Trials Centre at Sheffield Teaching Hospital NHS Foundation Trust has recently achieved these goals for the first time through the APHINITY study. When you take into account the focus, size and profile of APHINITY, you gain a true understanding of the scale of their success.
APHINITY is testing the effectiveness of a drug called Pertuzumab on the aggressive HER2 positive form of breast cancer, at 700 sites worldwide. The study is sponsored by Roche and aims to see if Pertuzumab can prevent the return of breast cancer in women who have been successfully treated for the condition. But APHINITY cannot be viewed in isolation.
In November last year, findings from a study called CLEOPATRA revealed that Pertuzumab offered a step-change in treatment for patients with HER2 positive breast cancer. It attracted world-wide media coverage and brought attention to the progress of APHINITY. 700 sites attempted to be the first to open and recruit the first patient to APHINITY, but Sheffield Teaching Hospitals Foundation Trust managed to lead the world.
First site and first patient are seen as key performance indicators by the life-sciences industry because they demonstrate that resident research infrastructure provides an environment in which commercial studies can flourish. Jenny Gray, NCRN industry lead, explains why it is particularly challenging for UK sites supporting cancer studies to out-perform global competitors:
“Our ethical and regulatory processes ensure world-renowned standards for patient safety and data efficacy, but they also slow down set-up. In addition to these national approvals, each participating NHS Trust must give local approval for the study to run at their site. Oncology studies are complex to set up, include detailed radiological risk assessments and require input from almost all NHS service support departments. This increases the number of departmental sign-offs required, making it challenging for UK sites to open faster than anyone else.”
Sheffield Teaching Hospital’s success signified a remarkable turnaround in its research fortunes. Principal Investigator Professor Rob Coleman contextualises their progress:
“For many years we have been a research active site, but with a reputation for slow trial set up and long time to first patient enrolled. We struggled to coordinate the research set-up procedures required, and often staff shortages and inadequate funding stalled any progress. It wasn’t until we were able to effectively integrate the support of the Comprehensive Local Research Network (CLRN) with our existing NCRN resources that our performance began to improve.”
Over the last year, Sheffield Teaching Hospitals R&D have been first to complete Research and Development approvals for a number of studies in the UK. While the team has proved consistently quick and efficient they do not work alone and the Research Coordinator is quick to highlight the benefit of Network support:
“I have a really strong relationship with Lesley Bruce, the Manager for the North Trent NCRN. Her team has a streamlined system that I have co-opted into. They help us to establish if we can support a study quickly, by promptly supplying the information R&D need to ensure Governance and contract arrangements are finalised.”
This system is exemplified by the Network’s Clinical Trials Executive, a group that features the Research Coordinator and Lesley, alongside relevant staff such as data managers, pharmacists, research nurses, principal investigators and patient representatives.
This synchronization can be viewed across the NCRN as a whole. The last ten years have seen progression within UK-based cancer research in a number of ways. With NCRN support, every NHS hospital and cancer centre in England is now actively involved in cancer research. Additionally, the number of cancer patients participating in research has soared from one in 26 diagnosed, to around one in six patients – a higher proportion than any other European country or the USA. And the number of Industry studies recruiting to time and target has continued to increase.
Professor Coleman feels that initiatives promoted by the NCRN are helping sites such as Sheffield become more competitive:
"The model contract and costing template are both helping to speed up our negotiations with sponsors. Also, the central NCRN team make sure all principal investigators are aware of the time-to-target focus of commercial studies, which is vigorously disseminated by the Local Research Networks amongst site staff."
APHINITY provides further evidence that the delivery of cancer research in the UK is improving. For Professor David Cameron, Chief Investigator for APHINITY, this direction of travel gives room for optimism:
“The set-up of APHINITY was a joint process, with a commitment to collaboration on all sides throughout the UK. For example, sponsors often decide what sites they want, but Roche made the most of Network expertise, which was aided by UK-wide knowledge. Although we have a long way to go, APHINITY shows there is light at the end of the tunnel. We can compete with the rest of the world, but not by working alone.”