(UroToday.com) A series of talks were given on the regulations surrounding clinical and genomic data sharing in an attempt to establish a tissue biobank shepherded by the IBCN. In this series, Dr. Dyrskjot discussed the history of the UROMOL collaboration in an attempt to draw insights to guide the current effort.
The UROMOL project was borne out of funding to prospectively study molecular characteristics of NMIBC to identify and validate biomarkers of recurrence and progression. The project was carried out prior to the implementation of GDPR and was expanded to include 10 European clinical centers. Collection of samples were homogenized using SOPs for the collection of tumor, blood and urine carried out between 2008-12. Overall, the consortium collected information in >2,500 patients, with over 1,200 enrolled having tumor tissue procured. The samples were centrally processed through a series of quality checks, including verification of carcinoma cell percentage and central pathology review. This effort has resulted in several high impact publications, staring with characterization of the molecular landscape of NMIBC published in Cancer Cell in 2016. 1 In addition, the project creates enormous value for ongoing and future projects by providing access to a large biobank, comprehensive genomic data including DNA, RNA, and proteome analyses. There has also been the construction of tissue microarrays with long-term clinical annotation. The data has also been deposited into the European Genome-Phenome archive.
However, Dr. Dyrskjot outlines the difficulties of data sharing beyond the EGA. He started by noting the difficulty of sharing data referenced via patient ID, and pointed out that even if a single investigator was able to link the patient identifier to the study subject, data sharing system would break down. Further, sensitive data needs to be handled using data processor agreement/controller to controller agreements that can become very cumbersome to work with. Examples of sensitive data includes the subject’s race, politic views, genetic data, sexual orientation, etc. He further outlined the exhaustive process guarding data sharing. First, permission needs to be obtained from the National Ethics Committee in Denmark to state the purpose of the research, and who has access to data. Then, permission needs to be obtained from the Danish Data Protection Agency to share data; contracts that outline the use of the data along with permissions and terms with local legal institutions need to be made and signed. For Non-EU based groups, security clauses are included in the contracts, to demonstrate GDPR regulations are followed.
The study team is responsible for communication with all the organizations, throughout this laborious process, which creates a huge workload, and the PI is responsible for all matters of contract adherence. The entire process can take up to a year, which is not feasible given the frequency of the requests for data that Dr. Dyrskjot receives on a weekly basis. Dr. Dyrkjot is not overly optimistic about the future, as the process will not be made easier. Instead, he proposes that processed data can be shared with relative ease.
Presented by: Lars Dyrskjot, MSc, PhD, Aarhus University | AU · Department of Molecular Medicine
Written by: Roger Li, Urologic Oncologist, Moffitt Cancer Center, during the International Bladder Cancer Network Annual Meeting, September 28-October 1, 2022, Barcelona, Spain