Sweden hopes high-tech biomarker database will help trial recruitment
Tobias Sjöblom is Chair of U-CAN, a programme run out of Sweden’s Uppsala University with a grant from the government to create a large registry of standardised data, tumour and blood samples and biomolecules from cancer patients before, during and after therapy.
The data is used for therapeutic and academic purposes but also “to improve the attractiveness of Sweden for clinical trials,” Sjöblom told Outsourcing-Pharma.com, adding that the platform could change the way the country performs patient recruitment for complicated oncology studies.
Given Sweden’s relatively small population, “it can prevent some of the overenthusiasm [by CROs] – the clinic is typically very positive in the number of patients it can recruit for a trial.” Trials without enough patients can end up failing.
“This will get you a more precise answer as to how many patients are eligible, with very little work. You don’t need to go through records.”
The scheme was also praised by the head of Stockholm-Uppsala Life Sciences, Ola Bjorkman: “Saving a month in a clinical trial means a month saved in year five, which could be hundreds of millions of euros. It’s really important for pharma companies to get reliable figures on these things.”
Improvement
Sweden has a long history of keeping electronic medical records and “quality registries” of patient details. But typically it takes 12 months for forms on a cancer patient’s disease and treatment to be filled in and registered.
As a result, the lag of one year means the patient details are not helpful to CROs looking to recruit for oncology trials.
“They want real-time information to decide whether to do clinical trials. We also need much more detailed information than what is in the quality registries,” said Sjöblom.
The U-CAN databases collect biomolecules, tumour and blood samples, radiological images and other patient data, all in a standardised format. The programme has been running since 2010 at Uppsala and Umeå University Hospitals and has begun in the surrounding counties.
Almost 7,000 cancer sufferers are now in the system. The project aims to cover 30% of Sweden’s oncology patients.
U-CAN offers pharma companies research collaborations using longitudinal information and biobanked material.
It is currently working on a Phase I trial for personalised breast cancer vaccines with German firm Biontec, “where the personalisation is based on the inexpression and mutation profile of the patient tumour – it’s one of the more sophisticated early clinical trials.”
U-CAN is also collaborating with Swedish firm Olink, which develops antibody-based assays for plasma, and with a company looking for patients for circulating tumour DNA (ctDNA) research.
