The Clinical Trials and Biostatistics Unit (CTBU) designs, conducts, and facilitates high quality clinical trials, non-trial clinical studies, and biostatistical research – with both academic and industry collaborators. The unit uses regulatory approved and industry standard electronic data capture systems (EDC) to develop clinical databases and manage multi-centre and multi-national clinical studies. Staff are trained in good clinical practice (GCP) and conduct clinical studies according to regulatory requirements and pharmaceutical industry standards.
The unit also leads a number of clinical studies in the field of diabetes and cardiovascular disease. Our current research activities include:
- evaluation of the cardiometabolic effects of new anti-diabetes drugs
- clinical epidemiological studies using large longitudinal data
- identification and validation of ‘omics’ based biomarkers for autoimmune and metabolic diseases.
We also provide consulting services to both clinical researchers and bio-pharmaceutical companies.
Clinical Trials and Biostatistics unit – research services
The Clinical Trials and Biostatistics Unit is currently conducting phase I, II and II multi-centre and multi-national clinical trials and studies in various therapeutic areas, strictly following regulatory guidelines (FDA) and industry standard. Our group promotes the use of regulatory approved electronic data capture systems for all clinical studies. Systems are in place to ensure Clinical Data Interchange Standards Consortium (CDISC) compatible clinical and safety reporting to relevant regulatory bodies.
Professor Paul has a strong record of accomplishments in the field of study design, including designing multinational mega ‘outcome’ trials and complex early phase clinical studies. We also conduct simulation studies to support study designs, where required.
Consulting services in various aspects of study design including:
- identification and choice of primary and secondary outcomes
- protocol development
- comparative power analyses
- statistical analysis approaches.
Clinical database development and management
Key aspects include:
- electronic case report form (eCRF) development
- OpenClinica platform database development
- database web-hosting
- project research staff training
- randomisation services
- database monitoring
- database lock
- data downloads as required.
- development of statistical analysis plans
- statistical analyses
- specialised analyses for safety reporting
- development of charter for Data Safety Monitoring Boards (DSMB)
- statistical and clinical reporting
- active participation in manuscript writing.
Please contact Dr Sanjoy Paul for all clinical trial related queries.
Group Leader: Professor Sanjoy Paul
- Dr Margaret Haughton, Project Coordinator
- Dr Mayukh Samanta, Biostatistician
- Dr Kerenaftali Klein, Affiliate (Biostatistician)
- Julius Agbeve, Clinical Data Manager
- Ebenezer Owusu Adjah, PhD Student
- Olga Montvida, PhD Student
Journal articles (2012-2016)
Klein K, Hennig S, Paul SK. A Bayesian modelling approach with balancing informative prior for analysing imbalanced data. PLoS ONE 2016; In press
Roberts JA, Gordon YSC, Joynt GM, Paul SK, … , Lipman J. Sampling antibiotics in renal replacement therapy (SMARRT): an observational pharmacokinetic study in critically ill patients. BMC Infectious Diseases; 2016; 16:103.
Khunti K, Nikolajsen A, Thorsted BL, Andersen M, Davies MJ, Paul SK. Clinical inertia with regard to intensifying therapy among people with type 2 diabetes treated with basal insulin. Diabetes Obes Metab 2016; 18(4):401-9.
Paul S, Agbeve J, Maggs D, Best JH. Comparison of trajectories of self-monitored glucose levels by hypoglycaemia status over 52 weeks of treatment with insulin glargine or exenatide once weekly. J of Diabetes 2016; 8(1): 148-157.
Paul SK, Klein K, Majeed A, Khunti K. Association of smoking and concomitant use of metformin with cardiovascular events and mortality in people newly diagnosed with type 2 diabetes. J of Diabetes In press Jul 2015; (doi: 10.1111/1753-0407.12302).
Paul SK*, Klein K, Thorsted BL, Wolden ML, Khunti K* (*contributed equally). Delay in treatment intensification increases the risks of cardiovascular events in patients with type 2 diabetes. Cardiovasc Diabetol 2015; 14:100.
Khunti K, Davies M, Majeed A, Thorsted BL, Wolden ML, Paul SK. Hypoglycaemia and risk of cardiovascular disease and all-cause mortality in insulin treated people with type 1 and type 2 diabetes – a cohort study. Diabetes Care 2015; 38(2): 316-322.
Dulhunty JM, Roberts JA, Davis JS, Webb SAR, Bellomo R, Gomersall C, Shirwadkar C, Eastwood GM, Myburgh J, Paterson DL, Starr T, Paul SK, Lipman J. A multicenter randomized trial of continuous versus intermittent β-lactam infusion in severe sepsis. Am J Resp Crit Care Med 2015; 192(11):1298-305.
Paul SK, Klein K, Maggs D, Best JH. The association of the treatment with glucagon-like peptide-1 receptor agonist exenatide or insulin with cardiovascular outcomes in patients with type 2 diabetes: a retrospective observational study. Cardiovasc Diabetol 2015; 14(1):10.
Paul SK and Samanta M. Predicting upcoming glucose levels in patients with type 1 diabetes using a generalized autoregressive conditional heteroscedasticity modeling approach. Int J Stat Med Res 2015; 4:188-198
Benham H, Nel HJ, Law SC, Mehdi AM, Street S, Ramnoruth N, Pahau H, Lee BT, Ng J, Brunck MEG, Hyde C, Trouw LA, Dudek NL, Purcell AW, O’Sullivan BJ, Connolly JE, Paul S, Lê Cao KA, Thomas R. Citrullinated peptide dendritic cell immunotherapy in HLA risk-genotype+ Rheumatoid Arthritis patients. Sci Transl Med 2015; 7(290): 290ra87.
Vicenzino B, McPoil TG, Stephenson A, Paul SK. Orthosis-shaped sandals are as efficacious as in-shoe orthoses and better than flat sandals for plantar heel pain: A randomized control trial. PLoS ONE 10(12): e0142789.
Harris PNA, Peleg AY, Iredell J, Ingram PR, Miyakis S, Stewardson AJ, Rogers BA, McBryde ES, Roberts JA, Lipman J, Athan E, Paul SK, Baker P, Harris-Brown T, Paterson DL. Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial. Trials 2015, 16(1):24.
Paul SK, Maggs D, Klein K, Best JH. Dynamic risk factors associated with non-severe hypoglycaemia in patients treated with insulin glargine or exenatide once weekly. J of Diabetes 2015; 7:60-7.
Wyssusek K, Keys A, Yung J, Moloney E, Sivalingam P, Paul SK. Evaluation of perioperative predictors of acute kidney injury post orthotopic liver transplantation. Anaesth Intensive Care 2015; 43:757-63.
Fatehi F, Gray LC, Russell AW, Paul S. Validity study of video teleconsultation for the management of diabetes: a pilot randomized controlled trial. Diabetes Technol Ther 2015; 17:717-725
Badve S, Paul S, Klein K, Clayton P, Hawley C, Brown F, Boudville N, Polkinghorne K, McDonald S, Johnson D. The Association between body mass index and mortality in incident dialysis patients. PLoS ONE 2014; 9(12):e114897.
Thomas G, Klein K, Paul S. Statistical challenges in analysing large longitudinal patient-level data: The danger of misleading, clinical inferences with imputed data. J Indian Soc Agric Stat 2014; 68: 39-54.
Thomas G, Khunti K, Curcin V, Molokhia M, Millett C, Majeed, Paul S. Obesity paradox in people newly diagnosed with type 2 diabetes with and without prior cardiovascular disease. Diabetes Obes Metab 2014; 16(4):317-325.
Roberts JA, Paul SK, Akaova M, … , Lipman J for DALI Study Authors. DALI: Defining antibiotic levels in intensive care unit patients: Are current beta-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis 2014; 58:1072-83.
Pahau H, Brown MA, Paul S*, Thomas R*, Videm, V* (* contributed equally). Cardiovascular disease is increased prior to onset of rheumatoid arthritis but not osteoarthritis: the population-based Nord-Trondelag health study (HUNT). Arthritis Res Ther 2014; 16:R85
Hansen AR, Hughes BGM, Paul S, … , Joubert WL. A single institution, retrospective review of peri-operative chemotherapy in adult and adolescent patients with operable osteosarcoma. Asia Pac J Clin Oncol 2014; doi: 10.1111/ajco.12167 [Epub ahead of print]
White D, Pahau H, Duggan E, Paul S* and Thomas R* (*contributed equally). Trajectory of intensive treat-to-target disease modifying drug regimen in an observational study of an early rheumatoid arthritis cohort. BMJ Open 2013; 3(7) pii: e003083.
Green JB, Bethel AM, Ring A, Kaufman KD, Shapiro DR, Paul S, Califf RM and Holman RR for the TECOS Investigators. Rationale, design, and organization of a randomized, controlled trial evaluating cardiovascular outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J 2013; 166:983-989e7.
Khunti K, Fisher H, Paul S, Iqbal M, Davies MJ, Siriwardena N. Severe hypoglyaemia requiring emergency medical assistance by ambulance services in the East Midlands: A retrospective study. Prim Care Diabetes 2013; 7:159-165.
Ji LN*, Tong XL, Wang HY, … , Paul S* (*joint first authors). The efficacy and safety of a diabetes medicine comprising of traditional Chinese medicine and glibenclamide. PLoS ONE 2013; 8:e56703.
Khunti K, Weston C, Gholap N, Molokhia M, Paul S, Millett C, Curcin V, Majeed A, Davies MJ. All-cause mortality in relation to glycated haemoglobin in individuals with newly diagnosed type 2 diabetes: a retrospective cohort study. Br J Diabetes Vasc Dis 2013; 13:22-30.
Paul S, O’Regan K, St John A, Champion S, Stuart K, Crawford D. Interaction of serum ferritin and body mass index in patients with chronic hepatitis B: Improved prediction of cirrhosis. Hepatology 2013; 57(5): 2094-5.
Travers C, Byrne G, Pachana N, Klein K, Gray L. Prospective observational study of dementia and delirium in the acute hospital setting. Intern Med J. 2013; 43:262-269.
Peel N, Kuys S, Klein K. Gait speed as a measure in geriatric assessment in clinical settings: a systematic review. J Gerontol A: Biol Sci Med Sci 2013; 68:39-46.
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 Obes Metab 2012; 14: 826-834.
Klein K, Aarons L, ter Kiule FO, Nosten F, White NJ, Edstein MD, Teja-Isavadharm P. Population pharmacokinetics of halofantrine in healthy volunteers and patients with symptomatic falciparum malaria. J Pharm Pharmacol 2012; 64:1603-1613.
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. Br J Haematol 2012; 157:766-769.
Paul S, Thomas G, Majeed A, Khunti K, Klein K. Women develop type 2 diabetes at higher body mass indices than men. Diabetologia 2012; 55:1556-1557.
Salih S, Paul S, Klein K, Lakhan P, Gray L. Screening for delirium within the interRAI acute care assessment system. J Nutr Health Aging 2012; 16:695-700.
Klein K, Gueorguieva I, Aarons L. Population pharmacokinetic modelling of S-warfarin to evaluate the design of drug–drug interaction studies for CYP2C9. J Pharmacokinet Pharmacodyn 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. Leuk Res 2012; 36: 53-8.
Invited Lectures & Workshops (2012-2016)
Paul S. International Expert Group Forum Meeting, organised by AstraZeneca during the Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy) Conference, Istanbul, Turkey, 4 Nov 2015. Therapeutic inertia and the risk burden in patients with type 2 diabetes and the cardiovascular consequences.
Paul S. European Association for the Study of Diabetes 51st Annual Meeting, Stockholm, Sweden, 14-18 Sep 2015. Therapeutic inertia for glycaemic and blood pressure control in patients with type 2 diabetes mellitus and the cardiovascular consequences.
Paul S. Charles Sturt University, School of Computing and Mathematics, 28 Sep 2015. Prediction of glucose levels in patients with diabetes.
Paul S. Peking University Diabetes Forum, Beijing, China, 9-10 May 2015. Longitudinal profiles of body weight, blood pressure and lipids and their association with mortality risk in people with type 2 diabetes.
Paul S. Australian and New Zealand Obesity Society Annual Scientific Meeting, 16-18 Oct 2014, Sydney. Obesity paradox in people with newly diagnosed type 2 diabetes.
Paul S. American Diabetes Association, San Francisco, CA USA 13-17 Jun, 2014. Longitudinal profiles of blood pressure, lipids and HbA1c and their association with vascular and mortality risks in patients with T2DM under cardioprotective medications.
Paul S. Leicester Diabetes Centre, University of Leicester, UK, 14 Mar 2014. Clinical inertia and the associated cardiovascular risk in patients with type 2 diabetes.
Paul S. Bydureon Speaker Summit, AstraZeneca P/L, Melbourne, 30 Nov – 1 Dec, 2013. Current research in GLP-1 receptor agonists.
Paul S. University of Leicester, UK 12 Apr 2013. Evaluation of the trajectory of glycaemic control and its effects on vascular risks and mortality in type 2 diabetes patients: statistical challenges.
Paul S. BioPharma Australasia Convention, Sydney, 23-24 Aug, 2012. The importance of efficient study design to optimise trial-related costs.
Paul S. BioPharma Australasia Convention, Sydney, 23-24 Aug, 2012. Value focused clinical development: Directing your effort at things that matter (panel discussion).
Paul S. American Diabetes Association, Philadelphia, USA, 8-12 Jun 2012. Risk factors associated with hypoglycemia in patients treated with either exenatide once weekly or insulin glargine.
Conference Abstracts (2012-2016)
Paul S, Klein K. Clinical inertia, glycaemic burden and the associated cardiovascular risk: Evidence from US population with incident T2DM. 75th Scientific Sessions of the American Diabetes Association, Boston, MA USA, 6-9 Jun, 2015.
Paul S, Klein K, Shaw JW, Best JH. Glycemic control and long-term vascular risks in patients treated with insulin and incretin-based therapy. 74th Scientific Sessions of the American Diabetes Association, San Francisco, CA USA 13-17 Jun, 2014.
Paul S, Klein K, Majeed A, Khunti K. Longitudinal profiles of blood pressure, lipids and HbA1c and their association with vascular and mortality risks in patients with T2DM under cardioprotective medications. 74th Scientific Sessions of the American Diabetes Association, San Francisco, CA USA 13-17 Jun, 2014.
Klein K, Best J, Marso SP, Maggs D, Paul SK. Long-term cardiovascular outcomes with exenatide twice daily compared to insulin: A retrospective longitudinal study. European Association for the Study of Diabetes Annual Meeting, Barcelona, Spain, 23-27 Sep, 2013.
Paul S, Thorsted BL, Wolden M, Klein K, Khunti K. Delay in treatment intensification increases the risks of cardiovascular events in patients with type 2 diabetes. European Association for the Study of Diabetes Annual Meeting, Barcelona, Spain, 23-27 Sep, 2013.
Pahau H, Videm V, Paul S, Thomas R. Cardiovascular risk factors and events are more frequent prior to the onset of theumatoid arthritis than in the general population. American College of Rheumatology and ARHP Annual Meeting, Washington, DC, USA, 9-14 Nov, 2012.
Paul S, Klein K, Maggs D, Best J. Hypoglycaemia risk in type 2 diabetes: a multivariate analysis comparing exenatide once weekly with insulin glargine experience in a large clinical trial dataset. European Association for the Study of Diabetes Annual Meeting, Berlin, Germany, 1-5 October, 2012.
Khunti K, Fisher H, Paul S, Iqbal M, Davies M, Siriwardena A. Severe hypoglycaemia requiring emergency medical assistance by ambulance services in the East Midlands, UK. European Association for the Study of Diabetes Annual Meeting, Berlin, Germany, 1-5 October, 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. 72nd 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. 72nd 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). 72ndScientific 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. 72nd Scientific Sessions of the American Diabetes Association, Philadelphia, PA, USA, 8-12 Jun, 2012.
Studies in diabetes
Professor Paul’s group is conducting a number of early and late phase clinical trials in various therapeutic areas, including metabolic and autoimmune diseases, critical care, rheumatology, blood cancer, and geriatric medicine.
- Identification and validation of novel ‘omics’ based biomarkers that predict disease progression
- Development of early warning systems for hypoglycaemia
- Research program in clinical epidemiology and longitudinal data
- Evaluation of obesity paradox in patients with type 2 diabetes
- Evaluation of cardio-metabolic effects of GLP-1 receptor agonists in type 2 diabetes
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