Public Board of Directors papers 27.01.22

information are subject to strict governance and reporting requirements. These activities are undertaken in close collaboration with the University of Manchester where they involve academic ambitions One such collaboration was the Target trial in which the possibility of identifying potential treatments based on genomic analysis was being tested, with results being published in a prestigious journal. Within the specific governance and consent arrangements of this trial data on several hundred patients was appropriately shared with Roche. On one occasion, an error led to a single sample from this trial being mislabelled within Christie Private Care resulting in a potential breach of confidentiality. This matter was investigated according to our normal procedures by our Data Protection Officer and Caldicott Committee which concluded that the incident was “low risk” and the matter was closed. Based on our strong record of industry collaboration, separate discussions took place about the possibility of a much bigger collaboration with two major US companies with extensive capability and expertise in large volume genomic testing and data curation and analysis. The idea was to test the feasibility of offering genomic analysis to all patients at The Christie and using this data as a platform for a wide range of research and clinical applications. A project was set up to examine this possibility and to work through the very many practical, legal, financial, contractual, scientific, political and technological issues that would need to be addressed if this was to work. We recognised that this was at the cutting edge of industry collaboration and that significant development work would be required if it was to succeed. It was the complexities of this project that led to legitimate concerns being raised about the correct protocols being used. It is certainly true that the executive team were keen to see progress on this major undertaking and to understand that the correct governance was in place before any data would have been collected or shared within this wider partnership. In the event the project was halted in February 2020 (not 2021, as incorrectly stated in the “Rapid Review” report) because of concerns raised by academic staff pending a review by the medical directors of the way forward and resource required for such a large-scale programme. In response to the recommendations of the review we can confirm that: • Policies for data access, use of data for research and data sharing are continuously reviewed to maintain compliance with current regulatory frameworks and maintain fitness for purpose. Terms of Reference 4 - Whether there was a failure at The Trust to engage with clinicians in relation to commercial partnerships to ensure that: The scope and benefits were clear; The decision-making including procurement was transparent; The risks had been identified and mitigated before any agreements were signed The “Rapid Review” report confirms the earlier findings by Andrew Hughes that there was extensive involvement and engagement of clinicians in the work to evaluate the potential major commercial partnership with Roche and that, furthermore, it was escalation of concerns by clinicians to the Executive Team that led the project to be paused. The Trust commissioned the review and audit by Professor Andrew Hughes to identify lessons that could be learned from the discussions regarding a clinic-genomic database when evaluating future major commercial propositions. The Trust has reflected on and built these lessons into policy frameworks to guide future programmes. The proposition of creating a large clinic-genomic database in which Christie patients would have genomic profiles and clinical information collected and which would form a unique clinical, research and teaching resource was recognised as being extremely, if not uniquely, complex. In recognition of this complexity a formal project structure was established, overseen by the Managing Director of R+I and Education and reporting to the Chief

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