It’s becoming more difficult to conduct independent clinical research – Alkomiet Hasan

It’s becoming more difficult to conduct independent clinical research – Alkomiet Hasan

University clinics are under increasing financial pressure. For the next generation, this raises the question of whether conducting free scientific scholarship and clinical research simultaneously is still possible.

Research physicians are privileged; they can leave academia anytime and work exclusively in clinical practice. In the local medical research and care landscape, it is even possible to give academia a try without assuming any relevant personal risk. The freedom to work actively in patient care, while still teaching and researching with a comparatively high salary and relatively secure position, is a fair characterisation of what it is like to work at a university hospital.

"Fewer and fewer young doctors are aiming for careers in university hospitals"

However, in recent years these institutions have begun to look less attractive to the next generation of medical scientists. Fewer and fewer young doctors are aiming for careers in university hospitals – and the reasons they give are not work-life balance issues or the desire for greater flexibility, as much as the research itself. Increasingly, the freedom of research, teaching and patient care is being understood as a burden – as lack of freedom, even.

Inevitably, the question arises of whether academic freedom is even possible for doctors at all. Naturally, it is not just about a direct limiting of academic freedom or of particular research topics. There still exists a diverse array of excellent research possibilities for doctors who would like to work as either pure research scientists or ‘clinician scientists’. In this view, we physicians are indeed privileged compared to other scholars and scientists. Nevertheless, a topic of discussion at present is whether the current organisational structure of a university hospital does not indeed contain elements that in practice, at least in part, stand in opposition to the postulate of freedom of teaching and research.

"Clinics, whether publicly or privately financed, must still operate cost-effectively"

The dual role of university hospitals – patient care on the one hand, teaching and research on the other – contains tensions that may limit academic freedom. At the same time, trends in case law (see, for example, BvR 1553-14) should be distinguished from subtle limitations of scientific freedom in clinical practice. Clinics, whether publicly or privately financed, must still operate cost-effectively. Indeed, university hospitals are also geared towards cost-effectiveness, which is why many of the doctors who work there must tend primarily to patient care. This means that research time is relegated to evenings and weekends, despite clear divisions of labour in the job description for research and teaching, and this is experienced as servitude. Furthermore, if structural investments are made only on the basis of revenues from patient care, the call for profitability thus intensifies even more and gives way to profit-orientation. How, then, can research and teaching be free when economic interests take up so much of their space?

To make the tensions between academic freedom and profitability in clinical practice even clearer, we can use the example of a seriously ill individual, such as a child with a particular inborn error of a metabolic disorder or a young adult with therapy-resistant schizophrenia, or a person with a rare rheumatic disease. From the standpoint of modern research-based treatment, we may recommend longer hospital stays for such patient groups, as well as higher daily treatment costs, often with so-called off-label uses of medication. From a purely economic standpoint, such treatments are viewed critically and lead to discussions between researching physicians, administrators, and benefactors.

"clinical research translates what happens in the laboratory into clinical practice"

I should emphasise here that as a rule in Germany, a treatment choice has to be made according to the Specialist Standard: as such, a specialist examines the indications of a treatment in accordance with medical standards. This kind of evidence-based medicine does not always correspond directly to a treatment within the scope of a particular on-label therapy; on the contrary, in individual cases, and based on current scientific knowledge, a deviation or off-label use is called for. This research-based procedure has become increasingly limited by economic considerations, for example if a possibly effective experimental therapy is not listed in the catalogue of services. This worsens considerably on a federal level; that is, if scientifically recognised drugs with added value for patients are no longer remunerated on the basis of the Arzneimittelmarktneuordnungsgesetz (Pharmaceuticals Market Reorganisation Act, or AMNOG), and are therefore no longer offered in Germany, treatment deemed necessary also cannot be implemented. Naturally, the AMNOG does not limit academic freedom directly, but the consequences yielded by such a law reduce the scope of clinical use of new drugs.

All this becomes particularly dramatic in clinical research. Such research is a core element of university hospitals, especially in times when biomedical research is increasingly being shifted to non-university institutions. Furthermore, clinical research translates what happens in the laboratory into clinical practice. Only through this kind of research can therapies develop that are independent of industry but also close to the patient. This also makes it possible for medicine to evolve. Co-operation between clinical research and industry, on the other hand – for example in the context of licensing studies – does not provoke the same economic criticisms, as corresponding costs are borne by the contracting companies. Whether the freedom of the involved researcher is always given in such co-operations, however, is up for debate.

To prevent such critical issues and to promote the translation of fundamental knowledge into practice, investigator-initiated trials (IIT) – that is, studies that are initiated through scientists and doctors – should be an essential element of research at university hospitals. These are usually studies with specific scientific questions about patient-centred care that serve no commercial interest, but have the potential of the research’s direct use for patients.

„Ethical aspects must set the limits of academic freedom“

Carrying out clinical research is structurally and financially complex. I would like to hypothesise that it is becoming increasingly difficult to carry out such IITs. Consequently, this can in principle limit the freedom of an entire branch of research. In addition – as is often the case in science – there are financial constraints. For example, the possible (public) support for IITs does not cover the implementation costs; additionally, benefactors view these sorts of studies critically, because they fear ineffectiveness (which, of course, is exactly what is being tested).

The financial side can be solved, for example, through special DFG-programmes for the support of clinical research; through the establishment of a national fund, in which industry must pay in a specific amount; and through a research budget for the benefactors. At the same time, legal and official hurdles remain that are essential for patient safety; the current requirements do not, however, differentiate between a study carried out by a university working group and one planned by a large corporation. This has intensified in recent years, and many young physicians (in addition to more senior individuals) distance themselves from this sort of research. Special conditions could be created here, such as state provision of federal cost-free monitoring programs.

Does all of this mean that academic freedom is limited? I would answer no since the position of a research physician is still a privilege, and the endowments of German university hospitals are still, by international comparison, excellent. Even so, this environment is changing and financial pressure is increasing. As such, the image of the university hospital as a space for free and independent biomedical research is fading.

When we discuss whether academic freedom within biomedical research is limited, we inevitably debate within ethical frameworks; popular examples include reproductive medicine, human stem cell research, or research on non-consenting individuals (children, intensive care patients, people with dementia). As such, a rejection of studies should not be understood as a restriction on academic freedom. The question of whether ethical conditions restrict academic freedom in medical research cannot be answered by any one person. Instead, I will refer here to the statements and recommendations of the German Ethics Council. The title of its 2018 annual convention, ‘Human Dignity in Our Hands,’ already charts out the responsibility of every researching physician. Ethical aspects must set the limits of academic freedom in medical and especially clinical research.

That this is done according to clear rules is, in my view, the greatest freedom of the researching doctor in Germany; the freedom to research in a legally and ethically clear, and yet dynamic, environment, where the responsibility for human beings always comes first.

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