4 1 / 2024 // LEOPOLDINA / NEWS

International conference on the framework conditions for clinical studies on vulnerable people

The Leopoldina Working Group ( WG ) “ Framework conditions for clinical studies on vulnerable people ” started their work in summer 2023 . On 14 – 15 May 2024 a Leopoldina conference in cooperation with the German Medical Association and the World Medical Discussion will take place on this topic in Munich / Germany . A discussion with the Leopoldina members and spokespersons of the WG , paediatrician Stefan Pfister and medical ethicist Urban Wiesing .

Which groups of people are particularly vulnerable , Mr Wiesing ? Urban Wiesing : The question takes us directly to the heart of the problem : Are we talking about people that are much more likely to be treated unjustly , about higher damage potential from certain treatments , or is it more a question of being able to consent ? By some attempted definitions the list of vulnerable groups risks becoming extremely long . In an exaggerated sense , we could say that only white , well-off , cis men in their prime should be excluded . Yet this does not get us any further . So we have to be more specific and ask what characterises certain groups and which different measures can protect them . For example , are pregnant people fundamentally vulnerable or only in a certain regard ?

Mr Pfister , you treat children and adolescents with cancer . Are they all equally vulnerable ? Stefan Pfister : Here too , we have to differentiate . From the age of 12 and up , adolescents are considered partially capable of consent , patient information is already today adjusted to the age of children and is available for various age groups . The concept of vulnerability should provide protection in a positive sense . Should it , however , mean less

Stefan Pfister ML has been a Member of the Leopoldina since 2020 and is one of the two spokespersons of the Working Group “ Framework conditions for clinical studies on vulnerable people ”. He is Head of the Division of Pediatric Neurooncology at the German Cancer Research Center ( DKFZ ) in Heidelberg / Germany and Director of the Hopp Children ’ s Cancer Center Heidelberg ( KiTZ ). Image : Jung | DKFZ

or even no access to innovative treatments , it can also be a disadvantage . The concept of vulnerability then turns from a privilege into a problem , especially for children and adolescents with life-threatening or even fatal diseases .

While excellent studies now show that most medicines for children , calculated based on body surface size , is metabolised in the same way as in adults , we are still seeing long latency periods due to regulations aimed at actually protecting these groups when it comes to using medicine . Studies indicate around six years on average . This is absolutely unacceptable . Wiesing : We already differentiate in

Urban Wiesing ML has been a Member of the Leopoldina since 2011 and has been one of the two spokespersons of the Working Group “ Framework conditions for clinical studies on vulnerable people ” since 2023 . The medical ethicist and historian is Director of the Institute for Ethics and History of Medicine at the University of Tübingen / Germany .

Image : Universitätsklinikum Tübingen

terms of ability to consent . From a certain stage of development adolescents have a right to object to participation in research . Adolescents with chronic illnesses often understand their illness better than adults . If they can estimate the “ scope and significance ” of the research , they ought to give their “ informed consent ” to participating in a study .

The World Medical Association ’ s Declaration of Helsinki also refers to the risks and burdens related to participation in clinical studies . The aim of your working group is to specify what is actually meant by the stipulated “ minimum risk ” and “ minimum burden ” in a clini­