Information collected about you during the course of the trial will be kept strictly confidential in the same way as all of your other medical records. Information about your disease and progress will be sent by your doctors to the FOxTROT Study Office at the University of Birmingham Clinical Trials Unit (BCTU), on paper and electronically, where it will be securely stored under the provisions of the 2018 Data Protection Act and/or applicable laws and regulations. Your details will also be sent to NHS Information Centre so that NHS and government records can be used to follow your progress. Your GP, and the other doctors involved in your clinical care, will be kept informed, but otherwise all information about you and your treatment will remain confidential.
If you take part in the study, your relevant medical records may be inspected by authorised individuals from the BCTU and by Cancer Research UK (who are funding the study). They may also be looked at by the regulatory authorities. The purpose of this is to check that the study is being carried out correctly.
The CT scans taken during the course of the trial and the associated CT reports will be stored and reviewed, in confidence, by the FOxTROT Lead Radiologist at The Royal Marsden NHS Foundation Trust.
A pharmaceutical company, Amgen, is providing antibody (panitumumab). At the end of the study, a copy of the trial data will be sent to Amgen or its subsidiary companies. It will not be possible to identify you from these data and it will be kept strictly confidential.
When the trial is complete, the results will be published in a medical journal but no individual patients will be identified. If you would like to obtain a copy of the published results, please ask your doctor.
You can decide not to continue with study treatment at any time but, if you do, we would still like to follow up your progress. An important aim of the study is to find out how many patients complete their treatment and how people get on if they withdraw from treatment. For this reason, your data and samples would remain on file and be included in the final study analysis. In line with Good Clinical Practice guidelines, at the end of the study, the data will be securely archived for a minimum of 15 years. Arrangements for confidential destruction will then be made. If you withdraw consent for your data to be used, it will be confidentially destroyed.
If you consent, the research staff involved in FOxTROT may, in the future, access electronic data from your central NHS records, for example through the Health and Social Care Information Centre (HSCIC). This will provide researchers with information that is routinely gathered and stored during your visits to primary care and hospital, and will allow researchers to find out about your health after the trial has ended and the long-term effects of the treatments. By using routinely collected data we will be able to do this without needing to contact you further. In order to do this, we would need to send your name, gender, date of birth and NHS number with any request for information.
Your data is held, with your permission, in the interest of public health, and in line with the current Data Protection Act (2018).
For more information on how we use your data please see the Birmingham Clinical Trials Units' Data Sharing and Protection Policy.