1 / 2024 // LEOPOLDINA / NEWS 5
cal study on vulnerable people . Are there already ideas for how to achieve this ? Pfister : We weigh up risks and benefits every day in our profession . In the declaration , however , the severity of the illness has to date not been considered at all . Differentiating between light illnesses and diseases that could lead to a child ’ s death if left untreated is extremely important in our view . Wiesing : We make this differentiation in terms of treatments , so this should also be the case in research . Pfister : Especially since almost all child oncology treatments take place as part of clinical studies . Today , 70 to 80 percent of children and adolescents with cancer are initially treated as part of studies . This means that a strict differentiation between therapy and research is not possible .
We have the impression that the “ subsidiarity principle ”, according to which children and adolescents are only able to access new treatments after trials on enough adults , is interpreted differently in different countries and even within the European Union ( EU ).
What about adults not capable of consent ? They also count as a vulnerable group .
Wiesing : Yes , and that is why , following the principle of subsidiarity , research on new treatments should first take place on non-vulnerable people . But what does this actually mean ? Practically , it can lead to delays in the availability of new treatments , so we should then think about how we can reduce this time period in a way that is ethically acceptable .
When it comes to adults not capable of consent , group benefits of research is excluded as a criterion for permissibility , for example in studies on people with dementia . This is not the case for adolescents . However it is possible that some of them , in their healthier days , would have liked to help other patients by participating in research . Pfister : From paediatric research we know that 95 percent of families hope that the studies their child participates in also help other children , and this is very often the case when it is assumed that the currently affected child only has a small chance of benefiting from the study in question . Wiesing : We feel it is important to really look at the practical effects of differing regulations . But we are still at the beginning of this discussion .
What are you expecting to take away from the international conference “ Research with vulnerable people ” in May ? Pfister : We would like to better understand how countries can differently interpret the universally applicable Declaration of Helsinki and the EU regulations , including the Clinical Trial Regulation and the Data Protection Ordinance . In paediatrics especially , we see again and again that studies considered unproblematic in countries such as France , Italy , the Netherlands , United Kingdom and Scandinavia , meet with much more difficulty in Germany and need more time to receive approval from the authorities . What adjustments can we make here ? We need to look at how these regulations are interpreted and implemented . Wiesing : With the conference we ’ re aiming to bring together the work of various stakeholders . We consider the Leopoldina ’ s task to be the development of recommendations based on good data and a differentiated perspective .
■ THE INTERVIEW WAS CONDUCTED BY ADELHEID MÜLLER-LISSNER
Conference “ Research with vulnerable people ”
SYMPOSIUM ON NEWEST INSIGHTS INTO CAR-T CELL THERAPY
Experts in the area of CAR-T cell therapy are meeting on 8 to 9 April for an international symposium at the Leopoldina . The focus will be on the newest insights and implications of CAR-based treatments ( chimeric antigen receptors ) for uses other than the usual treatment of tumours .
For a long time , CAR-T cells were considered cancer treatment ’ s last hope . The T-cells of people with cancer are changed in such a way that the tumour cells can be specifically identified and eliminated . These cells are specific immune cells that are taken from the patient ’ s blood . They are then genetically modified in a laboratory so that they can target and switch off the immune cells ( B-cells ) attacking the organs . The modified T-cells are then returned to the body via infusion .
Nowadays the therapy is also used for auto-immune illnesses , infectious diseases , and most recently for illnesses such as cardiac fibrosis and cellular senescence . The presentation and discussion of current treatment approaches will be the focus of the symposium coordinated by the immunologist Georg Schett ML and the haematologist Andreas Mackensen . ■ STB
Image : Keith Chambers | Science Photo Library
Discussion “ CAR-T cell therapy for non-malignant diseases ”