Monthly Seminar: Beginners guide to adaptive and platform clinical trials

This month's Biostatistics seminar will be presented by Professor Robert Ware who leads the Griffith Biostatistics Unit at Griffith University. He has expertise in statistical inference, clinical trial design and data linkage studies. He has over 20 years' experience as an academic biostatistician and has co-authored more than 450 manuscripts. He collaborates with Griffith colleagues on biomedical, clinical and public health projects.

Seminar Overview

The popularity of adaptive and platform trials has increased markedly in recent years. Adaptive designs can make clinical trials more flexible by utilising results accumulating within the trial to modify the trials’ course in accordance with pre-specified rules. These trials are often more efficient, informative and ethical than trials with a traditional fixed design since they can often be completed more quickly and at lower cost. Platform trials can study multiple interventions for the same disease, with new interventions added, assessed and removed as the trial progresses. This seminar will introduce adaptive and platform trials, and discuss their advantages and disadvantages compared to traditional trial designs.

Thursday 18th April from 12:00 - 13:00 in G39_1.16 (Gold Coast campus - Griffith University) and by MS Teams

Designing, managing, analyzing, and interpreting data in health research studies

Griffith Biostatistics Unit is an expert at designing, managing, analysing, and interpreting data in health research studies. Maintaining the highest quality standards in health research involving human participants is essential, and design and statistical methods play a vital role in ensuring the validity and reliability of study results.

Given its significance, our work has far-reaching implications in clinical, public health, and health service research areas. Our researchers take a proactive approach to advancing the field through both methodological and applied research, while also collaborating with many clinical and biomedical investigators at Griffith University and Gold Coast University Hospital to advance cutting-edge findings.

What we do

Research

We lead our own research programs and collaborate both within Griffith and externally to enable the delivery of high-quality research. We work with a wide variety of partners and undertake a wide variety of research activities, including partnering on large grant applications, leading methodological research, and advising on and conducting the data management and analysis phases of research projects.

Education

We provide a series of research training activities, including seminars and short courses in our expert areas. We provide supervision and mentoring to early career researchers, and have extensive experience supervising higher degree research students who either want to undertake methodological work, or who could benefit from specific quantitative expertise.

Consultancy

We have extensive experience providing support to large and small projects. We have experience partnering with academic and commercial organisations, and can advise on all stages of the research journey, from study design to data collection to analysis and presentation. When partnering with the BBE team, health researchers will receive expert guidance and consultancy services based on rigorous, evidence-based approaches.

Our strengths

Our strengths define us as a cohesive and accomplished team, setting the foundation for our exceptional capabilities. With a team of dedicated professionals and academics at our core, we consistently showcase impressive expertise in addressing intricate challenges head-on. We seamlessly integrate various disciplines, including biostatistics, bioinformatics, data management, and epidemiology, to establish ourselves as a driving force in contemporary health research. Our collaborative approach fuels synergies that lead to pioneering insights, while our adept use of advanced computational techniques propels us toward innovative solutions that push the boundaries of health science. Our unwavering commitment to enhancing healthcare outcomes through rigorous research, insightful data analysis, and methodologies rooted in robust research practices underscores our determination to make a tangible impact in the field. By merging Clinical Epidemiology, Biostatistics, and Data Management, we emphasize the pursuit of top-tier research, leaving a lasting imprint on the trajectory of health advancements. Our strengths encompass not only our skill set but also our resolute pursuit of excellence, solidifying our role in shaping a healthier future for all.

Research team

Professor Robert Ware

Professor Ware is a biostatistician and clinical epidemiologist who has worked as an academic biostatistician for more than 20-years. He has extensive experience working with clinical colleagues on both randomised trials and cohort studies and has developed an extensive theoretical and practical knowledge of the design, conduct and analysis of both observational and experimental studies. Robert has led the Biostatistics team at Griffith since 2016.

Professor Angus Ng

Professor Angus Ng is an experienced biostatistician, with expertise in statistical modelling and computation, image analysis, machine learning, and survival analysis. In the field of mixture model-based cluster analysis he has pioneered the theoretical development of random-effects models for the analysis of complex heterogeneous and correlated data. Angus is an Associate Editor of the Journal of Statistical Computation and Simulation and a member of the ARC College of Experts.

Dr Ping Zhang

Dr Zhang is a health informatician and bioinformatician. Ping’s passion is utilising data analysis and computational modelling to get the maximum value from complex real-world data. She has developed computational modelling techniques and applied them to various health related research, such as diagnosis of cancers, influenza, cardiovascular diseases and diabetes, prediction of progression of Alzheimer’s, vaccine target identification and vaccine scheduling optimisation.

Dr Diana Hermith-Ramirez

Dr Hermith-Ramirez is an expert in bioinformatics, data analysis, biostatistics, and data management. She has a background in molecular biology and computer science. Her research focuses on computational and biostatistical approaches to analysing biological and clinical data, particularly in public health and clinical research. Diana is committed to using her skills to make a positive impact on health and medical research. She is currently a clinical research data manager for several NHMRC and MRFF-funded projects.

Dr Asmaa El-Heneidy

Dr El-Heneidy is a Research Fellow in Biostatistics at the Menzies Health Institute Queensland. Her PhD studies were focused on Infectious Disease epidemiology. These applied interests reflect her passion for understanding the transmission dynamics, risk factors, and prevention strategies associated with these specific health concerns. By conducting research in these areas, Asmaa contributes valuable insights to the development of effective interventions and evidence-based policies.

Dr Brett Dyer

Dr Dyer is a biostatistics research fellow whose research has focused on investigating the association between diabetes and frozen shoulder using primary care medical records. His main passion is using causal inference methods, especially using causal mediation analysis. Additionally, Brett has gained experience in analysing electronic health records, prognostic factor research, survival analysis, and joint modelling of longitudinal and time-to-event data.

Ms Lyn McPherson

With a background in librarianship, Lyn McPherson worked as a research assistant in cancer prevention research. After managing a large NHMRC funded RCT she became research coordinator of the Queensland Centre for Intellectual and Developmental Disability. She has expertise in all stages of the research process from literature review and project design to publication. She has worked at Griffith University part-time since February 2018.

Mrs Emily Young

Emily Young has a BHthSc and completed her Masters in Epidemiology while working as a biostatistican for Professor Ware. She is currently the biostatistician for two large NHMRC funded clinical studies: one birth cohort study ad one stepped-wedge randomised trial. Emily has developed methodological and practical expertise in the design and analysis of experimental and observational data.

Mr Maharshi Patel

Maharshi Patel is a research assistant specializing in biostatistics, equipped with a versatile skill set. He actively engages in clinical projects within the healthcare and medical contexts. Maharshi's commitment to refining his skills in data management and analysis, alongside his diverse expertise, positions him to make a substantial impact in healthcare research. His proficiency in statistical methods underscores his dedication to making meaningful contributions to population health.

Ms Nazneen Sultana

Nazneen Sultana is an early-career biostatistician who is currently undertaking a PhD focusing on healthcare in mass gathering events. Nazneen’s PhD study is within the School of Nursing and Midwifery where she is under the supervision of A/Prof Jamie Ranse, Prof. Julia Crilly and Prof. Robert Ware. With an education background in statistics, her research interests include statistical modelling, missing data analysis, and time series modelling.

Ms Laura McCosker

Laura McCosker is an early career researcher in public health. Laura has a background in nursing, and as well as being enrolled in her PhD is completing an MPH through UNSW. Laura has a passion for improving health outcomes for at-risk, hard-to-reach populations. Her Ph.D focuses on vaccination delivery in people experiencing homelessness. As part of her studies Laura has conducted RCTs testing different strategies to improve vaccination uptake in this hard to reach population.

Ms Hasitha Kuruwita

Hasitha Kuruwita is an early career researcher in the field of computational modelling. Her primary research focus is around the implementation of artificial intelligence methods in healthcare, with a specific interest in big data analytics. Currently, she is pursuing her industrial Ph.D. under the supervision of Dr Ping Zhang, focusing on utilizing machine learning to develop predictive models for intensive care outcomes in patients with traumatic brain injury.

Dr Ajeevan Gautam

Dr Gautam has seven years of experience as a clinical anatomist and medical doctor. He is currently enrolled as a full-time PhD student under the supervision of Prof Angus Ng. His PhD Thesis focuses on optimising analytical methods when investigating clinical and interventional techniques in the field of cardiovascular medicine. Ajeevan is committed to having a positive influence on medical research and health. Dr Gautam has worked internationally as a clinician and biostatistician.

Dr Iresha Udayamalee

Dr Udayamalee is a dental surgeon with more than 17 years experience who has Master's and MD degrees in Dental Public Health. She is a research fellow at the School of Medicine and Dentistry, Griffith University and her passion for big data analysis and computational modelling led her to pursue her PhD in Artificial intelligence-mediated personalized treatment planning for Inflammatory Bowel Disease in which she is currently enrolled under the primary supervision of Dr Ping Zhang.

Mrs Nikki Fozzard

Nikki Fozzard is a biostatistician who has worked at Griffith University since 2012. She has a background in biomedical science, particularly in molecular biology and genetics. Nikki completed her Master of Biostatistics in 2021 and is currently pursuing a PhD under the supervision of Professor Robert Ware. Nikki has a full-time role as an academic in the School of Pharmacy and Medical Sciences as a lecturer in undergraduate biostatistics, where she has received many awards for her innovative teaching.

Ms Mari Takashima

Mari Takashima is a registered nurse and early career researcher with clinical epidemiology and biostatistics skills. She is passionate about improving patient care through evidence-based practice. Her research interests are paediatric respiratory infections, vascular access, nursing education, and research methodologies. She has experience in project management, data management, and statistical analyses in clinical trials and observational studies.

Dr Philip Jones

Philip Jones is an emergency medicine physician and biostatistician who currently works at Logan Hospital. As well as his clinical work, Philip undertakes biostatical analysis with emergency department colleagues from the Gold Coast University and Logan Hopitals. Philip recently graduated with an M.Biostat, degree from UQ, and has ongoing collaborations with the COVERED COVID research program and multiple ultrasound research studies through the Sonar Group.

Dr Adenike Soogun

Dr Adenike Soogun recently completed her PhD in Statistics from the University of Cape Town. Adenike is an Adjunct Research Fellow at Griffith University. She has expertise in statistical modelling, data analysis of complex data, teaching and research supervision across multidisciplinary areas. Her research interests include Bayesian spatial modelling, survival analysis, machine learning, predictive and copula modelling. Adenike has over 10 years’ experience in research and teaching.

Publications

Highlights


Snelling, P. J., P. Jones, D. Bade, R. Bindra, J. Byrnes, M. Davison, S. George, M. Moore, G. Keijzers and R. S. Ware (2023). "Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures." New England Journal of Medicine 388(22): 2049-2057.

A multicentre RCT showed that, in children presenting to an emergency department with a suspected upper arm fracture, initial diagnosis with ultrasound was non-inferior to X-ray in terms of physical function 4-weeks after injury. Prof Ware was Senior Author.

Ng, S. K., R. Tawiah, G. J. McLachlan and V. Gopalan (2023). "Joint frailty modeling of time-to-event data to elicit the evolution pathway of events: a generalized linear mixed model approach." Biostatistics 24(1): 108-123.

This paper is the first to use joint frailty modelling approach in survival analysis of time-to-event data with recurrent and terminal events, providing a powerful and robust method to elicit the pathway of comorbid conditions in cancer patients. Prof Ng was Lead Author.

Xiang, J., Xu, H. Pokharel, S. Li, J. Xue, F and P Zhang (2022). “Building a knowledge base for colorectal cancer patient care using formal concept analysis.” BMC Medical Informatics and Decision Making 21(11), 1-9.

A hierarchical clustering method was used to build a knowledge base with a population of colorectal cancer patients, from which the information retrieved can be used for treatment planning recommendations towards personalised medicine. Dr Zhang was Senior Author.

El-Heneidy, A.R. S. Ware, S. B. Lambert and K. Grimwood (2022). "Sapovirus infections in an Australian community-based healthy birth cohort during the first 2-years of life." Clinical Infectious Diseases 76(6):1043-49.

The epidemiology of sapovirus infections in a high-income country is described using community-based birth cohort data. Sapovirus infections are common in Australian children under 2-years of age. Asmaa El-Heneidy was the first author.

Dyer B. P., T. Rathod-Mistry, C. Burton, D. van der Windt and M Bucknall (2023). “Diabetes as a risk factor for the onset of frozen shoulder: a systematic review and meta-analysis.” BMJ Open 13(1):e062377.

This systematic review and meta-analysis summarised longitudinal observational studies to conclude that diabetes is associated with the onset of frozen shoulder. Dr Dyer was first author.

Takashima M. D., K. Grimwood, P. D. Sly, S. B. Lambert, K.J. Chappell, D. Watterson, P. Young, M. Kusel, B. Holt, P. Holt and R. S. Ware (2021). “Cord-blood respiratory syncytial virus antibodies and respiratory health in first 5 years of life.” Pediatric Pulmonology 56(12):3942-3951.

This methodological paper highlights the strengths and weaknesses of intention-to-treat and per protocol analysis frameworks. Understanding the qualities of each approach enhances the interpretability of research findings. Mari Takashima was first author.


All Publications 2024-2019


Innovative Services and Partnerships

Griffith University's Clinical Trial Unit provides state-of-the-art facilities and professional coordination services for phase I-IV clinical trials. We conduct a wide range of investigator-initiated trials across various therapeutic areas including infectious diseases, respiratory and neurological diseases.

The Griffith Randomisation Service provides automated centralised randomisation for research studies, overseen by experienced statisticians, researchers, and with the support of Griffith Information Services. The randomisation service is available for university trialists working in the academic, healthcare and industry sectors.

At the forefront of an evolving healthcare system, the Centre for Applied Health Economics (CAHE) conducts multidisciplinary research, including health economics, health services research, implementation science, and biostatistics. Our work delivers leading advice with significant policy impact. We employ innovative methods and analysis to address complex problems, providing economic and health benefits. The evidence we produce influences health policy and practice, translating into real-world improvements globally. We also contribute to the development of health systems and share knowledge and skills in health technology assessment with other countries.

The Menzies Health Institute Queensland (MHIQ) conducts lifecycle research to improve health and wellbeing. Our three programs—Disability and Rehabilitation, Healthcare Practice and Survivorship, and Infectious Diseases and Immunology—align with local and national health priorities. With a Clinical Trial Unit, Gold Coast BioBank, Centre for Applied Health Economics, and biostatistics experts, we prioritize innovation, research translation, and meaningful partnerships.

Through leadership and innovation in teaching, research and community engagement, Griffith Health helps to create sustained improvement in health and healthcare for local, national and international communities. Our degrees provide students with the theoretical guidance and practical experience necessary to ensure their success as they transition into the next generation of health professionals.

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Griffith Biostatistics, Bioinformatics, and Epidemiology (BBE)