Hôpitaux Robert Schuman’s Clinical Research Unit


Under the direction of Prof. Dr Claude Braun and Dr Maike Aurich, this unit, which is supervised and financed by the Hôpitaux Robert Schuman’s Foundation (FHRS, Director Mr Georges Heirendt), aims to strengthen the management of these research projects, facilitate research by doctors, and establish and strengthen collaborations with the country’s research institutes. It also ensures that all legal, administrative and financial aspects of each research project are handled in compliance with current regulations and international quality standards such as Good Clinical Practice.

How important is research for patients at HRS?

Supervised and funded by the FHRS, clinical research is an integral part of the Robert Schuman Hospitals’ mission, enabling our patients to benefit from innovative diagnostic and therapeutic approaches. Patients who voluntarily agree to take part in a clinical trial can not only benefit personally, but also enable many other patients to benefit from treatments that would never have been available if they had not been tested beforehand. What’s more, patients who agree to take part in a trial are particularly well supervised and supported.

It also helps hone the scientific curiosity and skills of our nursing staff, and is ultimately a key driver of the quality of care and teaching provided.

Thanks to the strong commitment of its doctors, HRS is currently involved in clinical trials, recruiting patients for interventional clinical studies (with drugs or medical devices) or observational studies, carried out in-house or in collaboration with national industrial (pharmaceutical companies) and academic partners such as the Luxembourg Institute of Health (LIH), the Laboratoire National de la Santé (LNS) or the University of Luxembourg. This highly supervised process is governed by a precise study protocol, and can only be carried out under certain conditions:

  • Aim to increase medical knowledge
  • Be led by competent people
  • Take all measures to protect research subjects
  • Obtain regulatory approvals and take all necessary legal and ethical steps
  • Gathering consent from research participants

These studies have an important role to play for patients, for our physician-researchers and for society as a whole, including the health authorities who fund healthcare. Indeed, these studies provide the scientific basis for recommendations on optimal treatment, and thus help to ensure the best use of available healthcare resources. These recommendations therefore play an important role in speeding up the transfer of basic research findings into everyday practice.

Who’s involved?

The most important stakeholder is, and always will be, the patient, who is at the heart of our concerns. They are the essential link in the chain, and their voluntary participation helps to improve the diagnosis and/or treatment of those who will later be affected by a similar disease.

Secondly, the study investigator at the clinical site plays a major role. He is the one who will propose to his patients to participate in a trial. The patient has no direct contact with the sponsor.

In addition to the support of the FHRS clinical research unit, a whole highly qualified team is involved alongside him: co-investigating physicians, coordinator, pharmacists, laboratory technicians, nurses, ATMs, technicians, and so on.

Within the HRS, we can count on the Hôpitaux Robert Schuman’s Fondation (FHRS, Director Mr Georges Heirendt) for considerable help in developing the unit. Experts from the FHRS Clinical Research Unit will check that the rights, safety and protection of research subjects are satisfied, that the data reported are accurate, complete and consistent with the documents in the patient’s medical file (the source documents), and that the research is conducted in accordance with the protocol, Good Clinical Practice and current legislative and regulatory provisions. The protection of our patients’ data is ensured in collaboration with Claude Poupart, our Data Protection Officer.

Externally, and in addition to the study sponsor (the industrial or academic sponsor who initiates a trial), FHRS works with a number of select partners to bring its clinical projects to fruition. The first partner is the Luxembourg Institute of Health (LIH), with its “Integrated Biobank of Luxembourg” (IBBL), and above all with its Centre d’Investigation et d’Epidémiologie Cliniques (CIEC), which acts as the national coordinating center for clinical research activities. Other national partners include, not surprisingly, the University of Luxembourg, with whom we collaborate on numerous clinical projects, but particularly at teaching level. The LNS is also a first-rate partner for specialized projects.

What is the role of this clinical research unit?

The unit’s role is to centralize requests and to professionalize clinical research within the institution, covering all aspects of commercial and academic research, both economically and organizationally.

The trials or clinical studies carried out by our multidisciplinary teams are as follows:

  • Or local studies carried out in collaboration with the academic world,
  • Studies also carried out at other national and international centers,

The support provided is for any Robert Schuman Hospitals professional wishing to initiate a clinical research activity, or strengthen an existing one. The unit also provides support for clinical investigation when studies are set up, and oversees the dissemination of research information within the establishment. The clinical research unit is also responsible for ensuring compliance with the regulatory and ethical environment specific to clinical research.

The main tasks are as follows:

  • Operational centralization of clinical research among the various stakeholders
  • Study the feasibility of projects as a whole
  • Draw up budget forecasts for research projects
  • Assist principal investigators in drafting responses to calls for tender, writing research reports and publications
  • Assisting principal investigators in the search for dedicated research funds
  • Inform investigators of their commitments and obligations to the sponsor, in line with good clinical practice and regulations
  • Implement, monitor and control the technical and regulatory quality of research at the research sites, under the delegation and responsibility of the promoter
  • Liaise with external partners
  • Participate in coordinating and leading the hospital group’s research activities
  • Participate in training players within the hospital group.

What are the priorities of the clinical research unit?

The development of this unit means that the HRS will gain new scientific legitimacy, and that patients will be able to access the latest therapeutic advances as quickly as possible. Absolute priority is therefore given to studies that offer new hope for treatment or are of indisputable scientific interest.

Our second priority is in line with one of our corporate values: innovation linked to the digitization of data and new medical technologies. Through technologically innovative clinical projects, HRS aims to contribute to the development of the healthcare sector, in particular by working with healthcare technology companies. Our aim is to shorten the path from industrial prototype to clinical application. Our ambitions in the field of patient health technologies are extremely high. We want to take HRS to the pinnacle of medical innovation. Secondly, the pursuit of the research, innovation and teaching missions that the Cliniques share with the University of Luxembourg and the LIH represents the basis for biomedical excellence.

How can I contact the clinical research unit?

Please send your requests to the following address: clinical.research@hopitauxschuman.lu

Specify: Purpose of request: Project name + stage of development (feasibility/startup/clinical phase)

Good clinical practice must be respected. In Luxembourg, no trial, study or clinical experiment may be carried out on human beings with a view to developing biological or medical knowledge without prior authorization from the Minister, with the opinions of the Health Department and the National Research Ethics Committee (CNER) having been sought beforehand. As most clinical research is based on the processing of “personal health data” from an identified person (nominative data) or an identifiable person (coded or pseudonymized data), data protection must also be ensured.