Center for Clinical Studies
Main Emphasis
Das Studienzentrum ist die Schnittstelle zwischen Grundlagenwissenschaft und Patientenversorgung in der Klinik und dem angegliederten Versorgungszentrum. Unsere Expertise liegt in der Planung, Organisation und Durchführung klinischer Studien. Unser Spektrum umfasst translationale Forschungsprojekte in enger Kooperation mit Grundlagenwissenschaftlern, Verbundstudien pneumologischer und infektiologischer Fachverbände und Arzneimittelstudien der pharmazeutischen Industrie.
Unser Fokus sind übertragbare und nicht-übertragbare Erkrankungen der Atemwege. Ein Schwerpunkt ist die klinische Tuberkuloseforschung. Andere Studien betreffen Asthma, Allergie, COPD, Pneumonie, Weaning und andere pneumologische Erkrankungen. Zudem führen wir onkologische Studien durch.
For further information please visit our website sz.fz-borstel.de
- Information for Study Participants
- Information for Doctors
- Information for Scientists
- Information for Sponsors
The Center for Clinical Studies Borstel has three main focuses: translational research, diagnostic or biomolecular investigations on clinical biomaterials and trials according to German Medicine Act (Arzneimittelgesetz, AMG) on therapeutic compounds (phases I - IV). On the on hand, the laboratory infrastructure in Borstel facilitates rapid access to clinical and research laboratories on the campus. On the other hand, our close proximity to the hospital wards and the outpatient department of the “Medizinische Klinik” allows easy recruitment of ambulatory and bed-bound patients for clinical research.
Based on this closely woven connection between basic research, laboratories and patient management, we can offer a wide spectrum of resources and options that can be used for scientific purposes. More details about our facilities and staff can be found here. Subsequently, we offer a wide range of services: planning, layout and conduct of Investigator Initiated Trials, conceptual design of study protocols, consultant services for sponsors, CRO / SMO services for sponsors of industry driven projects, etc. Please visit the following sites for further details.
Know-how
Pre-study
- Conceptual design of clinical trials
- Statistical estimations
- Budget calculations
- Creation of study protocols
- CRF design
- Communication with the Ethics Committee
During the study
- Conduct of clinical trials according to ICH-GCP
- Screening and recruiting of participants
- Professional data acquisition and documentation
- Serious Adverse Events (SAE) and Unexpected Adverse Events (UAE) Management
- Cooperation and support for external monitors and CRAs
Post-study
- Data storage
- Statistical analysis
- Writing of reports
- Support and consultant services for publications
2023
Hamada, Y, Gupta, RK, Quartagno, M, Izzard, A, Acuna-Villaorduna, C, Altet, N, Diel, R, Dominguez, J, Floyd, S, Gupta, A, Huerga, H, Jones-López, EC, Kinikar, A, Lange, C, van Leth, F, Liu, Q, Lu, W, Lu, P, Rueda, IL, Martinez, L, Mbandi, SK, Muñoz, L, Padilla, ES, Paradkar, M, Scriba, T, Sester, M, Shanaube, K, Sharma, SK, Sloot, R, Sotgiu, G, Thiruvengadam, K, Vashishtha, R, Abubakar, I & Rangaka, MX 2023, 'Predictive performance of interferon-gamma release assays and the tuberculin skin test for incident tuberculosis: an individual participant data meta-analysis', EClinicalMedicine, Jg. 56, S. 101815. https://doi.org/10.1016/j.eclinm.2022.101815
Lange, C, Köhler, N & Günther, G 2023, 'Regimens for Drug-Resistant Tuberculosis', New England Journal of Medicine, Jg. 388, Nr. 2, S. 189-191. https://doi.org/10.1056/NEJMc2213970
Vierbuchen, T, Agarwal, S, Johnson, JL, Galia, L, Lei, X, Stein, K, Olagnier, D, Gaede, KI, Herzmann, C, Holm, CK, Heine, H, Pai, A, O'Hara Hall, A, Hoebe, K & Fitzgerald, KA 2023, 'The lncRNA LUCAT1 is elevated in inflammatory disease and restrains inflammation by regulating the splicing and stability of NR4A2', PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, Jg. 120, Nr. 1, S. e2213715120. https://doi.org/10.1073/pnas.2213715120
2022
Alter, P, Kahnert, K, Trudzinski, FC, Bals, R, Watz, H, Speicher, T, Söhler, S, Andreas, S, Welte, T, Rabe, KF, Wouters, EFM, Sassmann-Schweda, A, Wirtz, H, Ficker, JH, Vogelmeier, CF & Jörres, RA 2022, 'Disease Progression and Age as Factors Underlying Multimorbidity in Patients with COPD: Results from COSYCONET', International journal of chronic obstructive pulmonary disease, Jg. 17, S. 1703-1713. https://doi.org/10.2147/COPD.S364812
Brandenburg, J, Heyckendorf, J, Marwitz, F, Zehethofer, N, Linnemann, L, Gisch, N, Karaköse, H, Reimann, M, Kranzer, K, Kalsdorf, B, Sanchez-Carballo, P, Weinkauf, M, Scholz, V, Malm, S, Homolka, S, Gaede, KI, Herzmann, C, Schaible, UE, Hölscher, C, Reiling, N & Schwudke, D 2022, 'Tuberculostearic Acid-Containing Phosphatidylinositols as Markers of Bacterial Burden in Tuberculosis', ACS infectious diseases, Jg. 8, Nr. 7, S. 1303-1315. https://doi.org/10.1021/acsinfecdis.2c00075
Chesov, E, Chesov, D, Maurer, FP, Andres, S, Utpatel, C, Barilar, I, Donica, A, Reimann, M, Niemann, S, Lange, C, Crudu, V, Heyckendorf, J & Merker, M 2022, 'Emergence of bedaquiline resistance in a high tuberculosis burden country', The European respiratory journal, Jg. 59, Nr. 3, 2100621. https://doi.org/10.1183/13993003.00621-2021
Freundt, K, Herzmann, C, Biedziak, D, Scheffzük, C, Gaede, KI & Stamme, C 2022, 'Surfactant protein A enhances the degradation of LPS-induced TLR4 in primary alveolar macrophages involving Rab7, β-arrestin2, and mTORC1', INFECTION AND IMMUNITY , Jg. 90, Nr. 2, S. e0025021. https://doi.org/10.1128/IAI.00250-21
Lüthgen, M, Rüller, S & Herzmann, C 2022, 'Characteristics of the deventilation syndrome in COPD patients treated with non-invasive ventilation: an explorative study', RESPIRATORY RESEARCH , Jg. 23, Nr. 1, S. 13. https://doi.org/10.1186/s12931-022-01924-y
Head
Scientific staff