Research

Each year, numerous national and international studies are conducted in our hospitals and we support employees interested in research topics. They include resident physicians who wish to undertake a doctoral thesis or employees from other healthcare professions who are working towards a masters or doctoral degree. Excellent research management makes Helios an attractive option for medical personnel carrying out research and for employees in other professions. It also makes Helios an appealing company for job applicants.

Collaborative research

We also work closely on research projects with public and private partners and in this way make a contribution to the creation of new knowledge. Research projects are conducted at our hospitals which are in some cases publicly funded. Support for these may come from the innovation fund of the Gemeinsamer Bundesausschuss (G-BA, Federal Joint Committee), from the German Federal Ministry of Education and Research (BMBF), or from the ministries of individual federal states. The projects generally focus on the development of new forms of healthcare provision and on treatment pathways, in other words courses of medical treatment.

Collaborative research projects with manufacturers concentrate on testing new technologies in clinical settings to assess their benefits.

Helios also works with the Robert Koch Institut (RKI) to provide data on severe acute respiratory infections (ICOSARI) and thereby monitor the occurrence of influenza and Covid-19 viruses in hospitals.

Helios Health Institute (HHI): reliable partner for clinical research projects

Since 2021, all research-relevant activities carried out under the auspices of Helios have been consolidated in the Helios Health Institute (HHI). Since 2022, the HHI has been the central point of contact for all employees of Helios hospitals and its subsidiaries who want to conduct research. The Institute validates the study design to ensure compliance with all regulatory requirements for research.

The applicable Helios Group Research Policy stipulates that in order to protect patients, every research project, including all necessary documents, must first be submitted to the HHI for assessment and review. The HHI reviews research projects with regard to regulatory and content-related methodological requirements, performs a legal review of the project contracts, and advises on data protection. This enables hospitals to ensure that scientific, ethical, and legal requirements are met and that the project complies with applicable guidelines or quality standards.

All researchers are required to provide evidence of their qualification to conduct clinical studies and to comply with the provisions of the Helios Group Research Policy. In self-initiated studies, full responsibility lies with the persons leading the study.

In 2023, a total of 300 (2022: 337) studies were reviewed for Helios, most of which had the goal of improving treatment options for patients. The focuses of the clinical studies in our hospitals are on cardiovascular diseases, oncology, and research into the provision of care.

Clinical studies: According to ethical and scientific standards for greater patient well-being

How effective are drugs? Is a medical product really effective? Clinical studies provide answers to these and other questions. They are the prerequisite for the approval of drugs, medical products, and other forms of treatment. Investigations into their efficacy and effectiveness are carried out under specified framework conditions. This enables any adverse effects to be identified at an early stage.

Why does Helios conduct clinical studies?

By participating in studies of this nature, patients have the opportunity to benefit from treatment methods which are not, or not yet, available in day-to-day clinical practice. Helios also offers the opportunity in a number of hospitals to take part in clinical studies, and to benefit from treatment with innovative therapeutic approaches.

What ethical and scientific standards are clinical studies at Helios based on?

Conducting clinical studies is subject to strict requirements. These include the Helios Group Research Policy and numerous external guidelines, national regulatory requirements, the Declaration of Helsinki issued by the World Medical Association, and the requirements of Good Clinical Practice (GCP). The GCP is an international ethical and scientific standard for planning, conduct, documentation, and reporting of clinical studies on humans. Compliance with these standards fosters public trust that the rights, safety and well-being of study participants are being protected and that the data collected in the course of the clinical study are credible. The regular GCP training courses organized by the HHI are compulsory for medical and non-medical staff conducting central study reviews.

How is compliance with these standards monitored?

The conduct of studies is monitored by audits and by inspections carried out by national, higher and regulatory authorities. If there are any complaints, appropriate corrective actions are initiated by the hospital involved and reported to the inspecting authority. In 2023, no external inspections and audits were carried out at the HHI.

What prerequisites have to be complied with at the beginning of a study?

A prerequisite for any study to begin is a vote or review by an independent ethics committee established under state law. All clinical studies are reviewed subject to this legislation by independent experts who are responsible for the relevant German state (Bundesland) or the local state medical association (Landesärztekammer). In the case of study projects being conducted of Helios physicians with university affiliation, the ethics committee of the university involved is responsible for the review of the study, depending on each state’s regulations. In experimental studies, researchers can carry out investigations in the laboratory, for example using tissue samples or blood material. These studies are also reviewed by an ethics committee. All studies using sample material from patients must be evaluated by the ethics committee.

If patients are interested in participating in a clinical trial, they discuss all issues in advance with the responsible investigator. These discussions follow a guideline that includes study-specific patient information approved by the ethics committee, and a declaration of consent. Only after evaluation by the ethics committee, and in accordance with the Helios Group Research Policy, are investigators permitted to use the documents.

In 2023, a total of 300 new studies were conducted or reviewed by Helios. The majority of them had the goal of improving therapies for patients. The studies were initiated at 36 hospitals and 46 studies were conducted on the initiative of Helios employees. The focuses of the clinical studies were oncology, hematology, and cardiology.