Clinical Trial Management

Objectives

The Hannover Clinical Trial Center GmbH (HCTC) is an academic contract research organization (ARO) providing the broad spectrum of clinical trial management services. The main shareholder of HCTC is the Hannover Medical School (MHH). HCTC acts as the sponsor representative in case of an investigator initiated clinical trial (IIT) under MHH sponsorship. Special emphasis is given to clinical studies employing cell and gene therapy products. HCTC combines the clinical expertise and academic leadership of a premier German teaching hospital with the full-service operational capabilities of a contract research organization. 

Clinical trial support:

  • Set-up of knowledge database for regulatory and legislative issues related to ATMPs (advanced-therapy medical products)
  • Preparation of GCP compliant SOPs for initiation and conduct of clinical trials with special emphasis on advanced-therapy medicinal products (ATMP)
  • Guidance in product development in preparation of first-in-man (FIM) clinical trials
  • Regulatory approval process of clinical trial protocols employing ATMPs
  • Project management of clinical trials
  • Clinical monitoring
  • Data management
  • Collaboration with the Institute of Clinical Pharmacology: Safety and pharmacovigilance supervision (electronic reporting system in compliance with the ICH-E2b Guideline)
  • Collaboration with the Institute of Biometrics: biostatistical design and evaluation of clinical trials
  • Associated member of KKS-Networky

Academic Collaborations

  • E. Mischak-Weissinger, Hannover Medical School, bone marrow transplantation
  • M. Sauer, Hannover Medical School, Pediatric Oncology, stem cell therapy
  • M. Manns, Hannover Medical School, Department of Gastroenterology
  • J. Bauersachs, Hannover Medical School, Department of Cardiology
  • R. Stripecke, Hannover Medical School, Department of Hematology and Oncology, REBIRTH Unit Regenerative Immune Therapies
  • H. Wedemeyer, Hannover Medical School, Department of Gastroenterology
  • Th. Lenarz, Hannover Medical School, Department of Oto-Rhino-Laryngology
  • Duke Clinical Research Institut (DCRI), Durham, North Carolina, USA
  • Harvard Clinical Research Institute (HCRI), Boston, USA
  • University of Florida, Department of Pulmonary Medicine, Miami, USA
  • Mario Negri Center for Diabetes Research, Bergamo, Italia
  • Steno Diabetes Research Center, Kopenhagen, Danmark
  • Institute for Clinical and Experimental Medicine, Diabetes Centre, Prague, Czech Republic
  • Athens University, Hippokration Hospital Diabetes Center, Athens, Greece
  • University Medical Center, Department of Medicine, Groningen, The Netherlands
  • University of Glasgow, Institute of Cardiovascular and Medical Sciences, Glasgow, United Kingdom
  • Institut Curie, Department of Medical Oncology, Paris, FranceDirection de la Recherche Médicale et de l'Innovation, CHU de Toulouse-Hôtel Dieu Saint-Jacques, Toulouse, France
  • Clinical Trials Center, University Zurich, University Hospital Zurich, Switzerland

Publications

2013 - ongoing

2016

Samuels S, Balint B, von der Leyen H, Hupe P, de Koning L, Kamoun C, Luscap-Rondof W, Wittkop U, Bagrintseva K, Popovic M, Kereszt A, Berns E, Kenter GG, Jordanova ES, Kamal M, Scholl S. Precision medicine in cancer: challenges and recommendations from an EU-funded cervical cancer biobanking study. Br J Cancer. 2016;115(12):1575-83.

Lindhardt M, Persson F, Currie G, Pontillo C, Beige J, Delles C, von der Leyen H, Mischak H, Navis G, Noutsou M, Ortiz A, Ruggenenti PL, Rychlik I, Spasovski G, Rossing P. Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY): essential study design and rationale of a randomised clinical multicentre trial. BMJ Open. 2016;6(3):e010310.

Deterding K, Spinner CD, Schott E, Welzel TM, Gerken G, Klinker HH, Spengler U, Wiegand J, zur Wiesch JS, Pathil A, Cornberg M, Umgelter A, Zollner C, Zeuzem S, Papkalla A, Weber K, Hardtke S, von der Leyen H, Koch A, von Witzendorff D, Manns MP, Wedemeyer H. Six weeks of sofosbuvir/ledipasvir treatment of acute hepatitis C virus genotype 1 monoinfection: Final results of the The German HepNet Acute HCV IV Study. Hepatology. 2016;63(1 Supp):416a-7a.

2015

>Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S, www.raids-fp7.eu RAc. From prospective biobanking to precision medicine: BIO-RAIDs - an EU study protocol in cervical cancer. BMC Cancer. 2015;15:842.

Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S, www.raids-fp7.eu RAc. From Prospective Biobanking to Precision Medicine: Bio-Raids - an Eu Study Protocol in Cervical Cancer. BMC Cancer. 2015;15:842.

Barthold M, Fischer I, Schröder C, Albrecht U, Rohde B. Klinische Forschungsvorhaben mit Medizinprodukten: Vorgehen einer akademischen Institution. Deut Z Klin Forsch 5, 2015, 34-38.

2014

Siwy J, Schanstra JP, Argiles A, Bakker SJ, Beige J, Boucek P, Brand K, Delles C, Duranton F, Fernandez-Fernandez B, Jankowski ML, Al Khatib M, Kunt T, Lajer M, Lichtinghagen R, Lindhardt M, Maahs DM, Mischak H, Mullen W, Navis G, Noutsou M, Ortiz A, Persson F, Petrie JR, Roob JM, Rossing P, Ruggenenti P, Rychlik I, Serra AL, Snell-Bergeon J, Spasovski G, Stojceva-Taneva O, Trillini M, von der Leyen H, Winklhofer-Roob BM, Zurbig P, Jankowski J. Multicentre Prospective Validation of a Urinary Peptidome-Based Classifier for the Diagnosis of Type 2 Diabetic Nephropathy. Nephrol Dial Transplant. 2014;29(8):1563-70. Epub 2014/03/05.

2006 - 2012

2012

Pincha M, Sundarasetty BS, Salguero G, Gutzmer R, Garritsen H, Macke L, Schneider A, Lenz D, Figueiredo C, Blasczyk R, Ruggiero E, Schmidt M, von Kalle C, Puff C, Modlich U, von der Leyen H, Wicke DC, Ganser A, Stripecke R. Identity, Potency, in Vivo Viability, and Scaling up Production of Lentiviral Vector-Induced Dendritic Cells for Melanoma Immunotherapy. Hum Gene Ther Methods. 2012;23(1):38-55.

Wicke DC, von der Leyen H. Behandlung der Restenose bei koronarer Herzkrankheit mittels NO-Synthase-Gentherapie (CAR-MP583): Ergebnisse der REGENT-I-Extension Studie. Deutsche Z Klin Forschung. 2012;5/6:34-7.

2011

Walter C, Rohde B, Wicke DC, Pohler C, Luhrmann A, von der Leyen H. [Regulatory Framework of Innovative Therapies : From Bench to Bedside]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011;54(7):803-10. Regulatorischer Rahmen fur neuartige Therapien. Vom Labor zur klinischen Prufung.

2009

Voelkel C, Lührmann A, Baum C, von der Leyen HE. Retrovirus mediated hematopoietic gene therapy: A European regulatory perspective with special focus on the situation in Germany. Cell Ther Transplant. 2009;1:e.000044.01. doi:10.3205/ctt-2009-en-000044.01

2007

H. von der Leyen, C.L. Voelkel, Hannover Clinical Trial Center - Zentrale Schnittstelle für das Management innovativer klinischer Forschung, Biospektrum, 7-2007, 801-2.