Queensland Clinical Trials & Biostatistics Centre

News

QCTBC Reports the First Clinical Exploratory Study on Cardio-metabolic Effects of GLP-1R Agonist
Sanjoy Paul invited to speak at World Diabetes Congress, Dubai, 4-8 December 2011
Sanjoy Paul invited to speak at Chinese Diabetes Society Scientific Meeting, Beijing, 23-26 November 2011
QCTBC-UQCCR winsUQ-CIEF grant to initiate Proteomics Study in Ovarian Cancer, November 2011
QCTBC Collaboration with Chinese Academy of Sciences & Peking University to Develop Proteomics Pipeline in Diabetes, November 2011

About Us

The Queensland Clinical Trials & Biostatistics Centre (QCTBC) is a school centre within the School of Population Health. The Centre was formed in September 2009 with the goal of promoting and running high quality clinical, non-clinical and biostatistical methodological studies, both locally and internationally.

QCTBC provides the necessary expertise and intrastructure to design, conduct, and facilitate high quality clinical trials, non-trial clinical studies and biostatistical research with both academic and industry collaborators. All professionals of the Centre are GCP trained, and conduct clinical studies strictly following the regulatory requirements (FDA) and pharmaceutical industry standard. The Centre is currently running Phase 1, -2 and -3 clinical trials, leading several clinical studies including evaluation of cardiometabolic effects of new anti-diabetes drug (GLP-1R agonists), proteomics and metabolomics, and methodological studies in Clinical Biostatistics. In addition, the Centre provides high quality consulting services to clinical researchers and bio-pharmaceutical companies.

Clinical Trials

QCTBC has the infrastructure & trained manpower to be able to conduct early and late phase clinical trials strictly following the regulatory guidelines (FDA) and biopharmaceutical industry standard. The Centre uses regulatory approved and industry standard electronic data capture systems (EDC) to develop clinical database and manage multicenter and multinational clinical studies. Systems are in place to ensure Clinical Data Interchange Standards Consortium (CDISC) compatible clinical and safety reporting to the regulatory bodies. The Centre has been actively involved in the design, protocol development, setup, database development, database management, statistical analysis and reporting, as well as the general management of clinical trials in a range of disease areas, with local and international academic and industry collaborators. QCTBC has a strong record of accomplishments in the field of study design, including designing multinational mega ‘outcome’ trials and complex early phase clinical studies. Further, the Centre has recently designed a complex PK/PD study, with the aim of developing a robust dosing algorithm for antibiotics in the field of intensive care medicine. The Centre has successfully conducted several ‘simulation’ studies to support study designs where reliable background clinical information was not available.

Study Design

QCTBC offers high-quality consulting services in the following aspects of study design:
Identification & choice of multiple primary and secondary study outcomes
Basis and justification for the number and time-window of study visits
Comparative power analyses for the primary outcome(s) with extensive simulation results, if necessary
Approach to adverse event reporting
Statistical analysis approaches
Development of study protocol

Clinical Database Development & Management

QCTBC has the technical expertise and experience in developing databases for clinical and longitudinal epidemiological studies, including all phases of clinical trials. The Centre promotes the use of regulatory approved electronic data capture (EDC) systems for all clinical studies that conform to GCP and regulatory guidelines such as 21 CFR Part 11, and is built on a modern architecture using leading standards. Key aspects of the database development and management include:

Development of electronic case report form (eCRF)
Development of a robust clinical database, on OpenClinica® platform
Validation of database and development of associated standard operating procedures (SOP)
Training of project research staff, including provision of appropriate manualWeb hosting of database
Randomisation services
Management & continuous monitoring of database
Interim data download, following study specific SOPs
Quality Assurance & Quality Control
Database lock and data download

Biostatistical Consulting

Development of Study Design & comparative power analysis
Development of statistical analysis plans for interim and main analyses of the studies
Development of charter for Data Safety & Monitoring Boards (DSMB), and provision of analysis and reporting for the DSMB
Statistical analyses
Specialised analyses for safety reporting
Statistical & clinical reporting
Active participation in manuscript writing

Please contact Dr. Sanjoy Paul for all clinical trial related queries.

Biostatistical Consulting

Development of Study Design & comparative power analysis
Development of statistical analysis plans for interim and main analyses of the studies
Development of charter for Data Safety & Monitoring Boards (DSMB), and provision of analysis and reporting for the DSMB
Statistical analyses
Specialised analyses for safety reporting
Statistical & clinical reporting
Active participation in manuscript writing

Please contact Dr. Sanjoy Paul for all clinical trial related queries.

Statistical consulting

QCTBC offers high-level biostatistical consulting services to both academic and corporate clients, in various fields of clinical studies.

Biostatistical Consulting

QCTBC offers high-level biostatistical consulting services to a number of Australian and international research institutes in various fields of clinical studies, including large clinical epidemiological studies in different disease areas. The biostatistical consulting services include:

Development of Study Design & comparative power analysis
Database development with regulatory compliance
Database management
Development of statistical analysis plans for interim and main analyses of the studies
Development of charter for Data Safety & Monitoring Boards (DSMB), and provision of analysis and reporting for the DSMB
Statistical analyses
Specialised analyses for safety reporting
Statistical & clinical reporting
Active participation in manuscript writing

Download consultancy request form and email the completed form to qctbc-consulting@sph.uq.edu.au. For details on the consultancy policy, please contact QCTBC.

Collaborations

We collaborate in clinical studies with academic and commercial organisations at all levels.

QCTBC is leading several studies in clinical trials and non-trial clinical studies in active collaboration with highly reputed international research institutes and pharmaceutical companies.

Active international collaborators:

University of Oxford, UK
Imperial College London, UK
University of Leicester, UK
University of North Carolina, USA
University of Minnesota, USA
Amylin Pharmaceuticals Inc., USA
Medtronic, USA
Hospira, USA
Chinese Academy of Sciences, China
Peking University, China
Guangzhou Zhongyi Pharmaceutical Co. Ltd., China

Collaborations within Australia:

Diamantina Institute, UQ
University of Queensland Centre for Clinical Research (UQCCR)
Baker IDI, Melbourne
Centre for Research in Geriatric Medicine, School of Medicine, UQ
Griffith Institute for Health & Medical Research, Griffith University
Dermatology Research Centre, School of Medicine, UQ
Cancer Collaborative Group, Princess Alexandra Hospital, Queensland Health
Diabetes and Endocrinology Department, Princess Alexandra Hospital, Queensland Health
Australian Leukaemia & Lymphoma Group

Major projects

Read about our major research projects.

Clinical Trials:

Phase III Clinical Trial: The efficacy and safety of a diabetes medicine comprising of traditional Chinese medicine and glibenclamide. In collaboration with Peking University People's Hospital, China

Phase III Clinical Trial: Promoting activity for frail aged in post-acute hospital settings – a randomised controlled trial of accelerometry. In collaboration with Centre for Research in Geriatric Medicine, UQ

Phase I Clinical Trial: Rheumatoid Arthritis. In collaboration with Diamantina Institute, UQ

Phase II Clinical Trial: ALLG-MM8 Trial. In collaboration with Cancer Services, Princess Alexandra Hospital

Clinical / Biostatistical Studies:

Initiation of Insulin in Type 2 Diabetes Patients Using CGMS Based Glycaemic Assessment

Prediction of incipient hypoglycaemia using continuous blood glucose monitoring system

Amylin Pharmaceuticals Inc., USA: Exploring the dynamics of inter-relationships between clinical & biochemical parameters in type 2 diabetes patients

Amylin Pharmaceuticals Inc., USA: Dynamics of weight change and glycaemic control in Type 2 Diabetes patients treated with Exenatide or Insulin

Imperial College, London, & University of Leicester, UK: Statistical analysis of disease progression in Type 2 Diabetes patients

University of Leicester, UK: Comparison of diabetic cardiovascular risk factors between the caucasian and South-Asian populations

Cancer Services & Pathology Queensland: WT1 Biomarker study

University of Oxford: Plant Sterols in Type 2 Diabetes

QCTBC Publications

A selection of our most recent publications.

Journal articles published by QCTBC (2009-2012)

Paul S, Best J, Klein K, Han J, Maggs D. Effects of HbA1c and weight reduction on blood pressure in patients with type 2 diabetes mellitus treated with exenatide. Diabetes, Obesity and Metabolism 2012. In Press.

Martin-Khan M, Flicker L, Wootton R, Loh P, Edwards H, Varghese P, Byrne GJ, Klein K, Gray L. The diagnostic accuracy of telegeriatrics for the diagnosis of dementia via video conferencing. Journal of the American Medical Directors Association 2012. In Press.

Khadem G, Scott IA, Klein K. Retrospective study of evaluation of iron deficiency anaemia in a tertiary hospital. Internal Medicine Journal 2012. In Press.

Mollee P, Tiley C, Cunningham I, Moore J, Prince M, Cannell P, Gibbons S, Tate J, Paul S, Mar Fan H and Gill DS. A Phase II Study of Risk-Adapted Intravenous Melphalan in Patients with AL Amyloidosis. British Journal of Haematology 2012. Article first published online: 6 Mar 2012.

Paul S, Thomas G, Majeed A, Khunti K, Klein K. Women develop type 2 diabetes at higher body mass indices than men. Diabetologia 2012. Article first published online: 21 Feb 2012.

Salih S, Paul S, Klein K, Lakhan P, Gray L. Screening for delirium within the interRAI acute care assessment system. The Journal of Nutrition, Health and Aging 2012. In press.

Klein K, Gueorguieva I, Aarons L. Population pharmacokinetic modelling of S-warfarin to evaluate the design of drug–drug interaction studies for CYP2C9. Journal of Pharmacokinetics and Pharmacodynamics 2012; 39: 147-160.

Gray JX, McMillen L, Mollee P, Paul S, Lane S, Bird R, Gill D, Saal R, Marlton P. WT1 expression as a marker of minimal residual disease, predicts outcome in acute myeloid leukemia when measured at post-consolidation. Leukemia Research 2012; 36(4): 53-8.

Muir J, Xu C, Paul S, Staib A, McNeil I, Singh P, Davidson S, Soyer HP, Sinnott M. Incorporating teledermatology into emergency medicine. Emergency Medicine Australasia 2011; 23: 562-568.

Bertin-Maghit S, Pang D, O’Sullivan BJ, Best S, Duggan E, Paul S, Thomas HE, Kay TWH, Harrison LC, Steptoe R, Thomas R. IL-1β produced in response to islet autoantigen presentation differentiates T-helper 17 cells at the expense of regulatory T cells: implications for the timing of tolerizing immunotherapy. Diabetes 2011; 60: 248-257.

Neil HAW, Ceglarek U, Thiery J, Paul S, Farmer A, Holman RR. Impact of atorvastatin and omega-3 ethyl esters 90 on plasma plant sterol concentrations and cholesterol synthesis in type 2 diabetes: A randomised placebo controlled factorial trial. Atherosclerosis 2010; 213: 512-517.

Enriquez-Puga A, Baker R, Paul S, Villoro-Valdes R. Effect of educational outreach on general practice prescribing of antibiotics and antidepressants: a two-year randomised controlled trial. Scand J Prim Health Care 2009; 27: 195-201.

Invited Lectures & Workshops (2010-2012)

Paul S. Modelling and clinical risk analysis. World Diabetes Congress Dubai, United Arab Emirates, 4-8 Dec, 2011.

Paul S. Trajectory analysis of blood pressure before death in patients with type 2 diabetes. 15^th Scientific Meeting of the Chinese Diabetes Society Beijing, China, 23-26 Nov, 2011.

Paul S. Effects of GLP-1 receptor agonist exenatide on cardiometabolic outomes in patients with type 2 diabetes. 15^th Scientific Meeting of the Chinese Diabetes Society Beijing, China, 23-26 Nov, 2011.

Paul S. The importance of smarter clinical study design to optimise related costs. World Pharma Trials Australia Forum, Melbourne, 8 Sep, 2011.

Paul S. Serum glycated albumin as a biomarker for glycaemic control in diabetic patients. Translational Research Excellence Conference (TRX10), Brisbane, QLD, 2010.

Paul S. Statistics for clinical trials and grant applications. Workshop in "Meet the Professors" session of ADS & ADEA 2010 Annual Scientific Meeting, Sydney, NSW.

Paul S. Recent studies in the management of type 2 diabetes patients and a simulation study to explore long-term scenario. Invited lecture at New Zealand Clinical Research Conference 2010, Auckland, New Zealand.

Paul S. Clinical Trials – An Overview of Design, Data Management & Analysis Aspects. Workshop presented at New Zealand Clinical Research Conference 2010, Auckland, New Zealand.

Paul S. Hypertension Management in Diabetes Patients - A Simulation Study. ARCS 2010 Annual Conference, Sydney, NSW, 28 May 2010.

Paul SK. Epidemiological view of hypertension management in diabetes patients and a simulation study to explore long-term scenario. Keynote speaker at a meeting organized by the China International Medical Foundation to finalise clinical guidelines on blood pressure control in diabetic patients, Beijing, China, 7 Mar 2010.

Paul S. Data management in clinical studies. Research Centre for Clinical and Community Practice Innovation, Griffith University, QLD, Mar 2010.

Conference Abstracts (2010-2012)

Paul S, Best JH, Klein K, Maggs D. Risk factors associated with hypoglycemia in patients treated with either exenatide once weekly or insulin glargine. 72^nd Scientific Sessions of the American Diabetes Association, Philadelphia, PA, USA, 8-12 Jun, 2012.

Paul S, Klein K, Thomas G, Khunti K. Blood pressure trajectories before death in patients with type 2 diabetes. 72^nd Scientific Sessions of the American Diabetes Association, Philadelphia, PA, USA, 8-12 Jun, 2012.

Paul S, Best JH, Khunti K, Klein K. Five-year population level trajectory of HbA1c (AIc) and its association with mortality in patients with type 2 diabetes (T2DM). 72^nd Scientific Sessions of the American Diabetes Association, Philadelphia, PA, USA, 8-12 Jun, 2012.

Zhang X, Zhang C, Chen Z, Ji L, Paul S. Serum metabolic analysis in the progression of glucose intolerance. 72^nd Scientific Sessions of the American Diabetes Association, Philadelphia, PA, USA, 8-12 Jun, 2012.

Paul S, Best J, Klein K, Han J, Maggs D. Effects of GLP-1 receptor agonist exenatide on cardiometabolic outcomes in patients with type 2 diabetes. Abstract No. DU-2335, World Diabetes Congress, Dubai, United Arab Emirates, Dec 4-8, 2011.

Paul S, Khunti K, Klein K. Trajectory effects of HbA1c and blood pressure on cardiovascular disease and mortality – A simulation study. Abstract No. DU-2334, World Diabetes Congress, Dubai, United Arab Emirates, Dec 4-8, 2011.

Paul S, Best J, Klein K, Han J, Maggs D. Glycemic and weight lowering effects of exenatide once weekly are associated with blood pressure changes in patients with T2DM. Poster 1077-P, 71^st Scientific Sessions of the American Diabetes Association, San Diego, CA USA, Jun 24-28, 2011. Diabetes 2011; 60: Suppl.1.

Paul S, Khunti K, Klein K. Time-varying effects of blood pressure on cardiovascular disease: A simulation study. Poster 525-P, 71^st Scientific Sessions of the American Diabetes Association, San Diego, CA USA, Jun 24-28, 2011. Diabetes 2011; 60: Suppl.1.

Mollee P, Tiley C, Cunningham I, Moore J, Prince M, Cannell P, Gibbons S, Tate J, Paul S, Gill DS. A phase II study of risk-adapted intravenous melphalan in patients with AL amyloidosis. Poster presentation 53^rd Annual Meeting and Exposition of the American Society of Hematology (ASH)/Symposium on the Basic Science of Hemostasis and Thrombosis, San Diego, CA, USA, Dec 10-13, 2011. Blood 2011; 118(21): 1700-1700.

Thomas R, Street S, Ramnoruth N, Pahau H, Law S, Brunck M, Hyde C, O'Sullivan B, Capini C, Tran A, Ng J, Paul, S. Feasibility, safety and clinical effects of a single intradermal administration of autologous tolerising dendritic cells exposed to citrullinated peptides in patients with rheumatoid arthritis. Meeting abstract No. 2430, presented at 75^th Annual Scientific Meeting of the American College of Rheumatology/46th Annual Scientific Meeting of the Association of Rheumatology Health Professionals, Chicago, IL, USA, Nov 4-9, 2011. Arthritis and Rheumatism 2011; 63(10) Suppl. S: S946-S946.

White D, Pahau H, Duggan E, Paul S, Thomas, R. Outcome of an intensive treat-to-target disease modifying drug regimen in early rheumatoid arthritis within the first month sets the response trajectory for one year. Poster presentation at ARA-RHPA 52^nd Annual Scientific Meeting, Brisbane, QLD, 14–17 May 2011. Internal Medicine Journal 2011; 41:42-42.

Paul S, Davies M, Gray L, Webb D, Mostafa S, Khunti K. Interaction effects of risk factors on HbA1c in south Asian and white caucasian populations. Poster 1355-P, 71^st Scientific Sessions of the American Diabetes Association, San Diego, CA USA, Jun 24-28, 2011. Diabetes 2011; 60 Suppl. 1.

Paul SK, Best J, Haughton M, Maggs D. Dynamics of weight change and glycaemic control in type 2 diabetes patients treated with exenatide BID or insulin. Presented at 70^th Scientific Sessions of the American Diabetes Association, Orlando, FL USA, 25-29 Jun, 2010. Diabetes 2010; 59 Suppl. 1: A181-A181.

Paul S, Davies L, Gray L, Webb D, Khunti K. Comparison of effects of risk factors on glycaemic measures in south Asian and white Caucasian people. ADS ADEA 2010 Delegate Handbook page 217. Presented at Australian Diabetes Society Annual Conference, Sydney, NSW, Australia, Sep 2010.

QCTBC staff

The QCTBC team

Sanjoy Paul, PhD MSc
Director, Associate Professor in Biostatistics

Margaret Haughton, PhD MAppSc BSc
Project Manager

Kerenaftali Klein, PhD MSc BSc(Hons)
Biostatistician

Namitha Sara Bobby, MCA BCA(Computer Sciences)
Data Manager and Programmer

Gijo Thomas, MSc BSc (Biostatistics)
PhD Student / Research Assistant

Other School of Population Health statisticians working on clinical studies:

Peter Baker, PhD
Senior Lecturer, Biostatistics

Rob Ware, PhD
Senior Lecturer, Biostatistics

Contact QCTBC

We are based at the Princess Alexandra Hospital in Brisbane, Queensland, Australia.