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Kooperationspartner des Instituts für Biometrie

  • ASTERIX - Advances in Small Trials dEsign for Regulatory Innovation and eXcellence, Grant Agreement No. 603160.

     

    Spineli LM, Jenz E, Großhennig A, Koch A. Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease. Orphanet J Rare Dis [Internet]. 2017;12(1):140. Available from: http://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0692-3


    Lasch F, Weber K, Chao MM, Koch A. A plea to provide best evidence in trials under sample-size restrictions: the example of pioglitazone to resolve leukoplakia and erythroplakia in Fanconi anemia patients. Orphanet J Rare Dis [Internet]. 2017;12(1):102. Available from: http://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0655-8


    Hasford J, Koch A. Ethische Aspekte der klinischen Prüfung bei seltenen Erkrankungen. Bundesgesundheitsblatt - Gesundheitsforsch - Gesundheitsschutz [Internet]. 2017;60(5):556–62. Available from: http://link.springer.com/10.1007/s00103-017-2537-6


    Gonnermann A, Kottas M, Koch A. Biometrische Entscheidungsunterstützung in Zulassung und Nutzenbewertung am Beispiel der Implikationen von heterogenen Ergebnissen in Untergruppen der Studienpopulation. Bundesgesundheitsblatt - Gesundheitsforsch - Gesundheitsschutz. 2015;58(3):274–82.


    Ristl R, Frommlet F, Koch A, Posch M. Fallback tests for co-primary endpoints. Stat Med. 2016;35(16):2669–86.


    Hilgers R-D, Roes K, Stallard N. and for the IDeAl, Asterix and InSPiRe project groups. Directions for new developments on statistical design and analysis of small population group trials. Orphanet J Rare Dis [Internet]. 2016;11:1–10. Available from: http://dx.doi.org/10.1186/s13023-016-0464-5.


    Koch A, Ziert Y. Does it help that efficacy has been proven once we start discussing (added) benefit? Biometrical J. 2016;58(1):89–103.

     

    Gonnermann A, Framke T, Großhennig A and Koch A. No solution yet for combining two independent studies in the presence of heterogeneity. Statistics in Medicine. 2015; 34 (16) pp. 2476-2480, DOI: 10.1002/sim.6473.

  • RIACT - Randomisierte multizentrische Doppelblindstudie der Phase III bei Patienten nach Nierentransplantation mit einer akuten zellulären Rejektion im Nierentransplantat nach Banff-Kriterien (Grad IA/IB) oder Banff Borderline Rejektion mit simultanem Kreatininanstieg (20% über baseline Kreatinin) und histologischem Nachweis eines Infiltrates mit CD20-positiven Lymphozyten zum Nachweis der Überlegenheit einer Therapie mit Steroidboli plus Rituximab/MabThera® im Vergleich zu einer alleinigen Therapie mit Steroidboli bezüglich der Nierenfunktion nach einem Jahr.

     

    Schiffer L, Schiffer M, Merkel S, Schwarz A, Mengel M, Jürgens C, Schroeder C, Zoerner AA, Püllmann K, Bröcker V, Becker JU, Dämmrich ME, Träder J, Großhennig A, Biertz F, Haller H, Koch A, Gwinner W. Rationale and design of the RIACT-study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial. Trials. 2012 Oct 26;13:199. doi: 10.1186/1745-6215-13-199.

  • ABACOPD Study - Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD.

     

    Rohde GGU, Koch A, Welte T. Randomized double blind placebo-controlled study to demonstrate that antibiotics are notneeded in moderate acute exacerbations of COPD – The ABACOPD Study. BMC Pulmonary Medicine 2015, 15:5

  • ASCONET - Teilprojekt 1 (Kohortenstudie) des Verbundes COSYCONET - Einfluss systemischer Manifestationen und Komorbiditäten auf den klinischen Zustand und Verlauf bei Patienten mit chronisch-obstruktiver Lungenerkrankung (COPD).

     

    Jörres RA, Welte T, Bals R, Koch A, Schnoor M, Vogelmeier C. Einfluss systemischer Manifestationen und Komorbiditäten auf den klinschen zustand und den Verlauf bei COPD. Eine Übersicht über die Kohortenstudie COSYCONET. Deutsche Medizinische Wochenschrift 2010, 135: 446-449.

     

    Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, GläserS, Holle R, Watz H, Korn S, Adaskina N, Biertz F, Vogel C, Vestbo J,Wouters EFM, Rabe KF, Söhler S, Koch A, Jörres RA, for the COSYCONET Study Group. The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir.Med. 2016; 112(18-24).

  • Prohearing - Randomized, double-blind, placebo-controlled phase II clinical trial on ACEMg mediated hearing preservation in cochlear implant patients receiving different electrode lengths.

     

    Scheper V, Leifholz M, von der Leyen H, Keller M, Denkena U, Koch A, Karch A, Miller J, Lenarz T. ACEMg-mediated hearing preservation in cochlear implant patients receiving different electrode lengths (PROHEARING): study protocol for a randomized controlled trial. Trials. 2016; 17:394. DOI 10.1186/s13063-016-1526-7.
     

  • NEO-CIRC - Dobutamine for NEOnatal CIRCulatory failure defined by novel biomarkers.

  • Hep-Net: German Network of Competence on Viral Hepatitis.

     

    Heidrich B, Cordes HJ, Klinker H, Möller B, Naumann U, Rossle M, Kraus MR, Böker KH, Roggel C, Schuchmann M, Stoehr A, Trein A, Hardtke S, Gonnermann A, Koch A, Wedemeyer H, Manns MP, Cornberg M (2015): Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Response (OPTEX Trial): A Prospective, Randomized, Two-Arm, Multicentre Phase IV Clinical Trial. PLoS One 2015; 10(6):e0128069.

     

    Deterding K, Grüner N, Buggisch P, Wiegand J, Galle PR, Spengler U, Hinrichsen H, Berg T, Potthoff A, Malek N, Großhennig A, Koch A, Diepolder H, Lüth S, Feyerabend S, Jung MC, Rogalska-Taranta M, Schlaphoff V, Cornberg M, Manns MP, Wedemeyer H (2013); for The Hep-Net Acute HCV-III Study Group. Delayed versus immediate treatment for patients with acute hepatitis C: a randomised controlled non-inferiority trial.Lancet Infect Dis. 2013 Mar 21.

    pii: S1473-3099(13)70059-8.

    doi: 10.1016/S1473-3099(13)70059-8.

     

    Wedemeyer H, Yurdaydìn C, Dalekos GN, Erhardt A, Çakaloğlu Y, Değertekin H, Gürel S, Zeuzem S, Zachou K, Bozkaya H, Koch A, Bock T, Dienes HP, Manns MP(2011); HIDIT Study Group. Peginterferon plus adefovir versus either drug alone for hepatitis delta. N Engl J Med. 2011 Jan 27;364(4):322-31. doi: 10.1056/NEJMoa0912696.

  • Massenspektrometrie-Ntx: Nicht invasive Diagnose der akuten Rejektion bei Nierentransplantatempfängern mittels Massenspektrometrie in Urinproben - eine multizentrische Phase III-Diagnostik Studie.

     

    Zapf A, Gwinner W, Karch A, Metzger J, Haller H, Koch A. Non-invasive diagnosis of acute rejection in renal transplant patients using mass spectrometry of urine samples - a multicentre phase 3 diagnostic accuracy study. BMC Nephrology (2015) 16:153, doi: 10.1186/s12882-015-0146-x

  • IVIST01: A multicentre, randomized, open-labeled study to steer immonosuppressive and antiviral therapy by measurement of virus- (CMV, ADV, HSV) specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients

     

    Ahlenstiel-Grunow T, Koch A, Großhennig A, Frömke C, Sester M, Sester U, Schröder C and Pape L. A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): study protocol for a randomized controlled trial. Trials 2014, 15:324.

  • TRANSNephro: Transition von Adoleszenten nach Nierentransplantation in die Erwachsenenbetreuung – Analyse der Versorgungssituation und prospektive, multizentrische Untersuchung eines neuen Transitionsmodells unter Einsatz von Fallmanagement und zeitgemäßer Telemedizin über Smartphones

     

    Kreuzer M, Prüfe J, Bethe D, Vogel C, Großhennig A, Koch A, Oldhafer M, Dierks ML, Albrecht UV, Müther S, Brunkhorst R, Pape L. The TRANSNephro-study examining a new transition model for post-kidney transplant adolescents and an analysis of the present health care: study protocol for a randomized controlled trial. Trials 2014, 15:505.   doi:10.1186/1745-6215-15-505

  • DIGIT-HF: DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure

    A multicenter, randomized, double-blind, placebo-controlled study to demonstrate that digitoxin reduces a composite of overall mortality and hospitalization for worsening heart failure in patients with chronic heart failure and reduced ejection fraction
    EudraCT: 2013-005326-38

     

    Bavendiek U, Aguirre DL, Koch A, Bauersachs J (2017): Assumption versus evidence: the case of digoxin in atrial fibrillation and heart failure. European Heart Journal, 0, 1–5. doi.org/10.1093/eurheartj/ehw577.



  • Pneumocephalus: Prospektive randomisierte Studie zur Analyse der Wirkung von 100% reinem normobarem Sauerstoff zur Behandlung des postoperativen Pneumocephalus nach neurochirurgischen Eingriffen in halbsitzender Position

     

    Hong B, Biertz F, Raab P, Scheinichen D, Ertl P, Grosshennig A, Nakamura M, Hermann EJ, Lang JM, Lanfermann H, Krauss J. Normobaric hyperoxia for treatment of pneumocephalus after posterior fossa surgery in the semisitting position: a prospective randomized controlled trial. PLoS One. 2015 May 20;10(5):e0125710. doi: 10.1371/journal.pone.0125710. eCollection 2015.

  • ONLINE-TICS: Randomized observer-blind clinical trial to demonstrate the efficacy and safety of internet-delivered behavioral treatment for adults with tic disorders.

     

    Jakubovski E, Reichert C, Karch A, Buddensiek N, Breuer D, Müller-Vahl K: The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders. Front Psychiatry; 7:119. doi: 10.3389/fpsyt.2016.00119.

  • CANNA-TICS: Randomized double-blind placebo-controlled trial to demonstrate the efficacy and safety of nabiximols in the treatment of adults with chronic tic disorders.

  • CHANGE-MRI: Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA) (CTEPH DIAGNOSIS Europe - MRI)




  • EPAZ: A randomized phase II trial comparing pazopanib with doxorubicin as first line treatment in elderly patients with metastatic or advanced soft tissue sarcoma

     

    Karch A, Koch A, Grünwald V (2016): A phase II trial comparing pazopanib with doxorubicin as first-line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (EPAZ): study protocol for a randomized controlled trial. Trials 2016, 17(1):312. doi: 10.1186/s13063-016-1434-x.

  • AOK-Studie: Evaluation der Effekte einer Präventionsmaßnahme zur Rückengesundheit

     

    Haufe S, Wiechmann K, Stein L, Kueck M, Smith A, Meineke S, et al. (2017): Low-dose, non-supervised, health insurance initiated exercise for the treatment and prevention of chronic low back pain in employees. Results from a randomized controlled trial. PLoS ONE 12(6): e0178585. doi.org/10.1371/journal.pone.0178585.


     

     

     

  • A randomized multicenter open-label controlled trial to show that mucous fistula refeeding reduces the time from enterostomy closure to full enteral feeds (MUCous FIstula REfeeding (“MUC-FIRE”) trial)

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