Case study: Remote monitoring has enabled crucial cancer research to continue during the pandemic
The Royal Surrey team are conducting clinical trials to investigate whether a novel therapeutic drug (177Lu-PSMA-617) can extend the lives of patients with Metastatic-Castration Resistant Prostate Cancer, an advanced type of prostate cancer that has spread to other parts of the body and is not responding to treatment.
Each year more than 47,500 men in the UK are diagnosed with prostate cancer and more than 11,500 die from the disease. It is the second most common cause of cancer death in men, accounting for 14%.
The Royal Surrey Hospital site, which has patients enrolled on the National Institute of Health Research-supported VISION study, was able to continue remotely monitoring participants throughout the pandemic using the Veeva Vault content management platform.
Marie-Claire Flavin, Radiation Oncology Research Team Leader who introduced the system, found it invaluable. She said: “The benefits of using the system have been huge. Most importantly, we were able continue to support the sponsor with monitoring and checking participant information by uploading redacted patient data throughout the pandemic. This was much easier than monitoring with the use of video calls with a screen share.
“Also, because we can continually upload data after completing an electronic patient report form, the data is verified as soon as it is entered, preventing a bulk upload and enabling an easier workload around data locks.
“A further benefit was that the system reduced the footfall we needed on site and the issue of multiple monitors wishing to attend at the same time when restrictions are reduced.”
To implement Veeva Vault, the first task was revising the contract with the project sponsor to increase costs for monitoring, as the preparation for virtual visits takes longer than in person.
A Data Protection Impact Assessment also needed to be in place to ensure correct governance. This required a new data sharing agreement and it took a few drafts to ensure that all parties were satisfied. An additional amendment was included to state that this was only for monitoring purposes, as the full contract was for the entire use of the system.
Marie-Claire found the most difficult part of the process was the time it took to draw up the contract. “We needed to liaise with Veeva Vault’s American team and, because of the time difference, communication was often delayed. It could take a day to get a reply to an email. It also meant that many evenings were spent on calls and webinars”, said Marie-Claire.
On whether she thinks remote data collection will continue once the coronavirus pandemic has finished, Marie-Claire said: “I think it will ultimately depend on funding for the system between the pharmaceutical company and Veeva Vault. However, I certainly found the system easy to accommodate and would highly recommend it to continue.
“We were lucky that the pharmaceutical company we are working with on this project collaborated with Veeva Vault. Without this platform we would not have been able to continue work on this important study during the pandemic.”
The VISION study, led by Guy's and St Thomas' NHS Foundation Trust, was recruiting patients across 12 sites across the UK as well as internationally.
Read more about the VISION study on the Journal of Clinical Oncology website.