(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. This was capped off by Dr. Lotan’s discussion of the concept of the IBCN biobank.
He first remarked that urine biomarkers has hitherto not been incorporated into bladder cancer management guidelines, with no role in hematuria workup, a very limited role in surveillance, and no role in therapy selection. The cause of this is that there has not been any clinical consequences based upon a marker result that has been defined. Dr. Lotan further assessed that the failure of these markers to make a clinical impact is due to the failure of research to adhere to clinical needs. This is further hampered by high expectation regarding accuracy, reproducibility, poor trial design, and the lack of validation and collaboration amongst investigators.
Marker development is shepherded through several phases: discovery of the biomarker within the laboratory, the establishment of an association to clinical endpoint, validation, assay development and clinical validation, commercialization and assessment of clinical benefit. Every step except for first requires clinical samples. Some of the roadblocks that exist in the way of biomarker development include distinguishing prognostic vs. predictive biomarkers, validation usually requires collaboration amongst several study centers. Each step takes time, money, and organization. Some the of the specific questions include how do you get centers to participate; how many patients can you expect from each center; and how long will it take to enroll. The time component is significant since there is a need to contract with each center, which makes it very costly to open trials. Finally, the development of biomarkers is not associated with the huge potential for financial upside that is seen in drug development, hence tempering the enthusiasm surrounding marker development.
To address many of these problems, Dr. Lotan proposed that IBCN should serve as a central repository of sample exchange (urine blood, tissue), through developing contracts with academic institutions or other urologic practice groups for the transfer of de-identified data. In such a system, any individual/company who wants to evaluate a marker does not need to go individually contact each participating institution, but instead can coordinate with IBCN. Sponsors of studies can ask for a certain number of samples, accordingly, IBCN may put out a call to members to see who is interested in study, and has the capacity to provide samples. Members would send samples directly to the company/individual through this network. There will be a cost that’s pre-established for acquiring samples that is paid out after the sample is received with clinical data. As a reward, each member who contributed over a certain percent (5-10%) of samples gets authorship on any scientific output, while the IBCN may charge a fee for the coordination efforts. If implemented, Dr. Lotan speculates that this system may save 6-12 months of activation time, as well as to provide cost savings, and results in increased intellectual benefits.
Presented by: Yair Lotan, MD, Professor of Urology, Chief of Urologic Oncology, and holder of the Helen J. and Robert S. Strauss Professorship in Urology at UT Southwestern Medical Center. Medical Director of the Urology Clinic at UT Southwestern and Parkland Health and Hospital System
Written by: Roger Li, Urologic Oncologist, Moffitt Cancer Center, during the International Bladder Cancer Network Annual Meeting, September 28-October 1, 2022, Barcelona, Spain