Each year, substantial capital is invested in research and development activities within the life science industry. This research, together with all the research conducted in the academic sphere, presents great potential to influence personalised medicine and healthcare of the future. Medicine, treatments, diagnostics and testing – virtually everything has a more personal approach with greater opportunities to tailor treatment for each patient. That is the idea. Life science research has a strong approach, but the challenge in translating vision into action remains.
No matter how great the results – research findings can be difficult to implement in clinical practice. This is one of the biggest risks to the life sciences research today; forgetting to investigate the application area before throwing a lot of money into the hotpot of brilliant research.
Centre for Research Ethics and Bioethics (CRB) at Uppsala University examines the possibilities for future implementation of research findings from the patient’s perspective. In many cases, the ethical aspect is investigated too late. CRB aims to spread awareness of the issue in order to increase the benefits of investments in life science research.
The ethical perspective
How do we communicate risk to the patient? This requires research at clinical level. “The life science industry is investing extensive amounts of resources in understanding the genetics, but much less on implementing the results in practice. This is a major problem worldwide. We need to promote international collaborations and increase understanding of how important it is to investigate the clinical applications early in the development process”, CRB Director Professor Mats Hansson explains.
There are many private players who deliver genetic risk information based on tremendous amounts of research. The overall risk of developing a particular disease depends only partly on genetics, and very much on lifestyle and environment. “We need to increase our knowledge of how patients are likely to manage risk information regarding genetics. Often when conducting research in genetics, there are incidental findings. There is a lively debate about how this should be handled”.
Some believe that all information should be assigned to the patient. Others argue that since the findings have not yet been validated through large-scale studies, it is unnecessary to provide information that may not mirror reality. “How much information does the patient need? How much information does the patient want? How should expected benefits in terms of an immediate favourable treatment response be balanced against risk of future serious adverse reactions? These are issues that we work here at CRB”, says Mats Hansson.
Conducting research on gene interaction with epigenetics and the environment requires large international collaborations with scientists from around the world. As an example, studies of rare diseases are conducted across geographical borders.
“In a particular example related to a skin disease in children, the research required collaboration of over 100 clinics in 30 countries. It took over two years to develop a basis for ethical approval, even though 97 percent of the ethical review boards accepted without further questions. This is a perfect example of bureaucracy shortcomings and the risk of delaying important findings that could benefit the patients”, Mats Hansson continues.
The European Commission has presented a proposal on how to deal with personal data. The way of storing, managing and analysing personal data will be the same in all EU member states. Mats Hansson argues the importance of having regulations that support life science research. The biggest challenge is presented by the Committee on Civil Liberties, Justice and Home Affairs, suggesting that research must not be exempted from the EU directive for how personal data will be handled, implying more strict procedures for consent that are not always in the best interest of the patients.