Clinical trials

Early-phase and proof-of-concept studies

We are a highly specialized, academia-affiliated research center for early-phase and proof-of-concept clinical trials

 

Fraunhofer ITEM has many years of experience and expertise in the field of clinical airway research, complemented by a unique state-of-the-art infrastructure for performing clinical trials. Our focus of research is on airway diseases, in particular asthma, COPD, and allergic rhinitis, and on interstitial lung diseases, especially idiopathic pulmonary fibrosis (IPF). Other therapeutic areas have been added over the past five years, including atopic dermatitis, inflammatory diseases and vaccine studies. 

At the Clinical Research Center Hannover (CRC Hannover), one of Europe’s leading-edge non-hospital clinical research centers, we operate in a collaborative working environment that includes outpatient clinics and overnight facilities for study participants, advanced medical equipment, magnetic resonance imaging (MRI) systems, and a state-of-the-art biobank for storing biological samples.

In cooperation with our partner at the CRC Hannover, the Hannover Medical School, we conduct clinical trials also in other therapeutic areas, mainly atopic dermatitis, psoriasis, and sleep disorders.

Fraunhofer ITEM scientists have developed a wide range of challenge models to test the human response, for example, to inhaled allergens (inhaled allergen challenge; Fraunhofer Allergen Challenge Chambers in particular). We have direct access to human samples such as bronchoalveolar lavage (BAL), sputum, serum, and plasma, and have our own immunological lab where we have access, for example, to flow cytometry and chip cytometry and can perform ultrasensitive biomarker measurements on an MSD multiplex platform.

A large database of both prescreened patients (with asthma, allergic rhinitis, COPD, atopic dermatitis, or idiopathic pulmonary fibrosis) and healthy volunteers and a professional recruitment team ensure reliable time lines in the performance of clinical trials. Our research department furthermore has access to five challenge chambers – the Fraunhofer Allergen Challenge Chambers in particular – for proof-of-concept studies with sophisticated study designs using natural pollen (grass, birch), allergen extracts (e.g. cat, house dust mite), ozone, or hypoxia.

Our service portfolio for clinical trials

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  • Scientific consultancy
  • Identification of an appropriate proof-of-concept model and study design for your clinical trial
  • Development of study protocols
  • Conduct of clinical trials
  • Preparation of patient information and informed consent forms (ICFs)
  • Submission of requests for ethical review of monocenter clinical trials
  • Recruitment of patients and healthy volunteers
  • Update and archiving of trial-related documents
  • Process monitoring by a separate quality assurance department

Our clinical research methods and technologies

Sleep laboratory

In 2018 Fraunhofer ITEM in Hannover extended the diagnostic capabilities in its clinical research by setting up a sleep laboratory. The aim is to investigate the effects of new drugs monitpring sleep disorders and other psychosomatic problems such as anxiety.

 

Fraunhofer Sputum Core Facility

Our sputum center is highly experienced in the organization, preparation (training, accreditation) and centralized sample analysis in multicenter clinical trials.

Exhaled particles

Tiny particles, collected non-invasively, are a rich source of information, e.g. about the biochemical composition of the lung mucosal fluid. In addition, exhaled particles enable insights into airway dimensions. 

Biomarkers

We process and analyze human biospecimens by means of a broad spectrum of innovative technologies and methods and use primary cells as in-vitro disease models.

Medical imaging

State-of-the-art imaging technology (MRI scanner for research only) enables noninvasive methods for quantifying morphological and functional biomarkers in our clinical research.

 

Respiratory diagnostics

Spirometry, bronchoscopy, body plethysmography, rhinomanometry, impulse oscillometry and others – we offer a broad spectrum of methods for use in clinical trials.

 

Challenge models

We have developed several challenge models and established our unique Fraunhofer Allergen Challenge Chambers, where up to 20 test subjects at the same time can be exposed to pollen and other allergens under controlled conditions.

Inflammation monitoring

Our repertoire for detailed observation and monitoring of inflammatory processes in the lungs includes a broad range of invasive and noninvasive methods.

Chip cytometry

Chip-based cell analysis, i.e. chip cytometry, allows iterative staining of cellular markers like in flow cytometry, but in addition enables analyses in stored samples.

 

CRC Hannover – one of Europe’s largest clinical research centers

The CRC Hannover, one of Europe’s largest non-hospital clinical research centers, pools competencies in early-phase and proof-of-concept studies in different therapeutic areas.
© Fraunhofer ITEM
The CRC Hannover, one of Europe’s largest non-hospital clinical research centers, pools competencies in early-phase and proof-of-concept studies in different therapeutic areas.

The whole Fraunhofer ITEM clinical research team operates in the Clinical Research Center Hannover (CRC Hannover), one of Europe’s largest non-hospital clinical research centers. The CRC Hannover opened in 2014 and maximizes benefits for patients by enabling leading academic experts to pool their expertise and collaborate. In this clinical research center, three legally independent research organizations are working under one roof. While clinical investigators of Fraunhofer ITEM and the Hannover Medical School perform early-phase clinical trials with new drugs and medical devices, researchers of the Helmholtz Center for Infection Research are conducting here a part of Germany’s largest health study, known as “German National Cohort” study.

Read more about the CRC Hannover

Out team

Our team at Fraunhofer ITEM
© Fraunhofer ITEM, Felix Schmitt

Our team of 46 dedicated specialists – including clinical investigators, study coordinators, clinical trial nurses, medical documentation specialists, clinical method developers, and biomarker analysts – will conduct your study in compliance with the highest quality standards.

Our renowned experts, (co-)authors of numerous publications with many years of experience in clinical and medical research, are able to provide the specific support you need in performing your clinical research project.

Our investigators

Contact

Jens Hohlfeld

Contact Press / Media

Prof. Dr. Jens Hohlfeld

Division Director of Airway Research

Phone +49 511 5350-8101

Philipp Badorrek

Contact Press / Media

Dr. Philipp Badorrek

Head of Department of Clinical Airway Research

Phone +49 511 5350-8130

Karine Danielyan, MBA

Contact Press / Media

Karine Danielyan, MBA

Business Development Airway Research Division

Phone +49 511 5350-8327