How patient data is advancing medicine

Many patients agree to donate their health data to research. Mitchell Levesque, Professor of Experimental Immunodermatology at the University of Zurich, explains how this valuable data is structured, secured and stored. He also argues that access to data should be standardized throughout Switzerland, as this is the only way that Swiss research will be able to keep pace with that of other countries.

Mitch Levesque is a researcher and data specialist. “Collecting health data from patients and – thanks to increasing IT capacities – storing it more quickly and cost-effectively is crucial to medical research in Switzerland,” he says. Levesque knows what he is talking about. As Professor of Experimental Immunodermatology at the University of Zurich, he leads clinical trials at the Department of Dermatology and works intensively on the treatment of skin cancer. In 2014, he began setting up a central tissue biobank. It now contains around 10,000 tissue samples from over 5,000 patients who have consented to their data being made available for research in anonymized and encrypted form. The biobank is used by researchers involved in translational cancer research projects being carried out as part of the University Research Priority Programs (URPP) and is part of SKINTEGRITY.CH, a Swiss-wide initiative on skin research.

“Tumor research is impossible without tissue banks,” adds Levesque, who is also a member of the Tumor Profiler Project (link) team, which analyzes patient data in unprecedented detail. The researchers have already had some initial success: the study results have been fed back into everyday clinical practice; in some patients, the cancer has been prevented from progressing further.

Why do patients donate their data?

However, donors suffering from an illness are not always able to benefit directly from research results. “It can take years before results are available,” Levesque explains. Donors are aware of this and have other reasons for donating their data: many want to aid the development of new treatments, drugs and therapies. Others are willing to donate their data out of a sense of solidarity with others who are dealing with illness. Their own family history can also play a role, as research using donor data enables the identification of disease-causing risk factors in future generations. For others, access to clinical trials is of direct personal interest. They gain access to new, as yet unapproved drugs or therapies, particularly in advanced clinical trials.

If patients agree to donate their data, the results of laboratory analyses and physical examinations such as blood pressure, X-rays, photos of skin changes, age or gender are stored. Biological samples such as blood, urine and tissue are also stored.

General consent

The use of patient data and samples for research purposes – known as secondary use – is regulated by the Swiss Human Research Act (Humanforschungsgesetz – HFG). By issuing a declaration of consent, also known as “general consent”, the donors consent to existing and future data and samples being made available. In encrypted or anonymized form, these can also be used by other institutions in Switzerland and abroad for research projects. “Tissue samples are released according to a standardized process in which scientific, legal and ethical aspects are taken into account,” says Levesque. “No conclusions about the donor can be drawn.”

Preventing cell stress 

But what exactly happens to the samples? How are they properly stored and preserved? The biobank at University Hospital Zurich contains, for example, tumor biopsies fixed in formalin or frozen human material that is suitable for molecular analyses. A number of tumor tissue microarrays – for DNA and RNA analyses – are also available. On the DNA microarray, all the genes of the organism that is being analyzed are arranged on a glass plate, the “gene chip”, as single-stranded DNA.

“The sensitive material, such as that from biopsies, is frozen,” explains the researcher. It is important to preserve cells so that they remain viable for years to come. The techniques and tools required to freeze cells properly are challenging. For example, researchers must prevent intracellular ice crystals and cell stress in order to preserve the valuable material along with the important data it contains for further research.

Standardizing data exchange and organizing it at a nationwide level

The methods used to analyze and process tissue samples and store them in standardized data structures must be consistent, as this is the only way that data can be compared. “Extensive data collection opens up new possibilities for treatment and therapy, but overall, the data exchange necessary for research is lacking in Switzerland,” says Levesque. There is an urgent need for agreement on consistent data storage and structuring methods, as this is the only way to ensure that sufficient data is available for research.

“Unfortunately, every hospital today has its own IT system. The patient data is therefore not always compatible with other systems and cannot easily be shared by the hospitals or used for research projects. There is no nationwide digital infrastructure,” says Levesque, looking to other countries, some of which are making faster progress in the area of data exchange.

Using new platforms

Levesque praises the “Biomedical Informatics Platform” launched by Academic Medicine Zurich, stating that it is a good step in the right direction. In the years to come, this will allow for the standardized management of research data in Zurich. The four participating university hospitals will send the anonymized data that they have collected for each research project to the new platform. There it will be collated, stored and standardized.

Levesque is also involved in the Swiss Personalized Health Network (SPHN) initiative. This initiative aims to secure research-relevant molecular and clinical health data and enable the exchange of data required for research. This would enable Switzerland to make progress in the field of data-driven personalized health research at both a national and international level. However, the data specialist warns that Swiss politicians must be prepared to provide cross-cantonal investment, otherwise the country will be left behind.

Health data:
This is data that relates to a person’s health condition. It includes information about health (diseases, symptoms, therapies) and the results of lab tests, but also details of the person’s lifestyle (diet, smoking, etc.). 

DNA (deoxyribonucleic acid):

DNA is the molecule that carries genetic information in cells and is passed on to subsequent generations. It is made up of two opposing strands arranged in a double helix structure.

RNA (ribonucleic acid):

RNA is also a carrier of genetic information, but it plays a key role in protein synthesis and other cellular functions. Unlike DNA, RNA usually consists of a single strand.

Translational research:

Translational research aims to quickly and efficiently translate laboratory findings into clinical applications that benefit patients.

Biobank:

Biobanks are collections of biological samples and related data in a structured form. Biobanks for medical research typically contain tissue samples, blood or other bodily fluids, as well as cells or DNA samples of human origin.

Immunodermatology:

Immunodermatology is a specialism that examines the interactions between the immune system and the skin. The focus here is particularly the immunological aspects of skin diseases.