AGITG 2019 Annual Scientific Meeting Highlights of Interest to Study Coordinators and Research Nurses

This year the AGITG Annual Scientific Meeting includes many sessions of interest to Study Coordinators and Research Nurses.

INVITED FACULTY MEMBERS OF INTEREST TO STUDY COORDINATORS AND RESEARCH NURSES INCLUDE:

Tanya Symons – T Symons Associates, Australia

Tanya Symons is a recognised and respected clinical trials consultant. Tanya established her consultancy in Australia, working for both Commonwealth and State governments. She is using her knowledge of international best practice to influence the streamlining and standardisation of research-related processes in Australia and authored the 2016 Safety Monitoring and Reporting Guidelines and its three supporting guidelines for the NHMRC. She is the GCP training provider for numerous organisations across Australia.

Doctor Matthew Burge – the Royal Brisbane and Women’s Hospital / the Prince Charles Hospital / Rockhampton Base Hospital, QLD, Australia

Dr Matt Burge is a medical oncologist with a strong interest in gastrointestinal malignancies. Dr Burge is currently staff specialist at the Royal Brisbane and Women’s Hospital, the Prince Charles Hospital and Rockhampton Base Hospital. He is also a visiting oncologist at the Mater Hospital in Rockhampton.

Dr Burge has a broad range of experience in most solid tumour types but has a particular interest in gastrointestinal malignancies. He is involved in a number of clinical trials at the Royal Brisbane Hospital across a range of malignancies. He is an active member of the AGITG and currently serves on the Lower GI Working Party.

Flynn Slattery – Animate Your Science, Adelaide, Australia

Flynn has a background in exercise science and has recently submitted his PhD thesis. His research looks at the respiratory health of professional firefighters in South Australia. Flynn now works at Animate Your Science, combining his science background with a passion for graphic design to communicate science to a broader audience.

Professor Nik Zeps – Epworth HealthCare, VIC, Australia

Dr. Zeps has been recently appointed as the inaugural Group Director of Research for Epworth HealthCare. Prior to that he was the Director of Research at St John of God HealthCare from 2012 to 2016 and head of their translational cancer research program since 2008.

He is an Adjunct Professor at the Eastern Clinical School of Monash University, in the School of Health Sciences at Curtin University and the Centre for Comparative Genomics at Murdoch University.

He was a member of the Australian Health Ethics Committee from 2006-2012 and the Research Committee of the National Health and Medical Research Council (NHMRC) of Australia from 2009-2015.

He is a board member and the chair of the Cancer Biology Group of the Clinical Oncology Society of Australia (COSA) and a member of the Scientific Advisory Committee of the Australasian Gastro-intestinal Trials Group (AGITG). He is chair of the Primary Care Collaborative Cancer Trials Group (PC4) Advisory committee and a member of the PC4 Scientific committee. His was a founding director and board member of the Australian Clinical Trials Alliance (ACTA).

He is the Australian representative on the Ethics and Policy Committee of the International Cancer Genome Consortium (ICGC) and was recently appointed Co-Chair of the Communication Committee of the ICGC-Precision Medicine initiative.

Professor John Simes – NHMRC Clinical Trials Centre, NSW, Australia

Professor Simes is a Senior Principal Research Fellow and Director of the NHMRC Clinical Trials Centre. He is a leading international researcher in clinical trials, particularly in cancer, cardiovascular disease, diabetes and neonatal medicine. He has contributed to over 300 peer-reviewed articles, with many having a significant impact on current knowledge and clinical practice.

John is a founding member of the Australian Clinical Trials Alliance (ACTA), formed in 2012 to promote effective and evidence based healthcare in Australia through investigator-initiated clinical trials.

John is a practising medical oncologist in neuro-oncology at Royal Prince Alfred Hospital and the Chris O’Brien Lifehouse, and is professor of clinical epidemiology, Faculty of Medicine, University of Sydney. He has taught medical students and postgraduate students at the University of Sydney since 1989. He was awarded the Cancer Achievement Award for lifetime achievement in oncology by the Medical Oncology Group of Australia (2010) and the Distinguished Harvard Alum Award (Biostatistics) from Harvard University (2009) in recognition of his work in research. He has recently been elected as a Fellow of the Australian Academy of Health and Medical Sciences. He is a member of research committees, trials groups and boards, including cancer cooperative groups and safety and data monitoring committees. He has recently been elected as a Fellow of the Australian Academy of Health and Medical Sciences and was named on the Clarivate Analytics 2018 Highly Cited Researchers List for 2018.

Doctor Claudia Rutherford – the Quality of Life Office, NSW, Australia

Dr Rutherford is a health psychology researcher with experience in conducting systematic reviews, multi-centre qualitative and quantitative research, mixed methods during early phase testing, development and evaluation of health-related conceptual framework and patient-reported outcome (PRO) measures, and psychometrics across multiple health conditions (including cancer). As a PRO specialist, she has a comprehensive set of methodological skills related to multi-centre research conduct and all aspects of PRO inclusion in clinical trial protocols. As part of her a Beckett fellowship, Claudia is leading a program of research aimed at implementing PROs into bowel cancer survivorship care for the purpose of detecting patient issues and ameliorating patient suffering through supportive care interventions. In her role as the Deputy Director of the Quality of Life Office, Dr Rutherford provides high quality, expert advice, training and technical support services relating to the inclusion of PRO measures into industry independent cancer clinical trials.

A/Prof Haryana Dhillon – the Centre for Medical Psychology and Evidence-based Decision-making (CeMPED) University of Sydney, Australia

Haryana is a Research Fellow in Cancer Survivorship at the Centre for Medical Psychology and Evidence-based Decision-making (CeMPED) University of Sydney. She is also a member of the Board of  the Clinical Oncological Society of Australia (COSA) and Council, and chair of the Survivorship Group of COSA.

Haryana co-leads a Cancer Survivorship Research Group based in the University of Sydney. The group is supported on peer-reviewed funding, allowing studies in cancer and cognition, physical activity in cancer populations, sleep disturbance and symptom control. She also maintains an active research interest in health literacy, communication in the cancer setting and patient education.

Grant Baker – the AGITG Consumer Advisory Panel, Australia

Grant joined the AGITG Consumer Advisory Panel in 2017. Grant has had an extensive association with GI cancer, both as a patient and a carer.

Andy Phay – the Queen Elizabeth Hospital, Adelaide, Australia

Andy worked in clinical research for 8 years in both medical oncology and malignant haematology at the Queen Elizabeth Hospital in Adelaide.

Following on from that, had some brief experience as the research manager with gastroenterology, cardiology, endocrinology and mental health at the Lyell McEwin Hospital.

More recently, has returned to cancer and is now the clinical research manager of oncology at the Lyell McEwin Hospital.

 

MEETING HIGHLIGHTS OF PARTICULAR INTEREST TO STUDY COORDINATORS AND RESEARCH NURSES INCLUDE:

TUESDAY 20 AUGUST

Study Coordinators’ Workshop:

Clinical Research is a rewarding and exciting field with a highly active global oncology community contributing to frequent advances in our understanding of cancer biology and treatment. This high volume of research necessitates that Study Coordinators/Research Nurses develop knowledge and skills in research development and conduct.

The Study Coordinator workshop provides an interesting education program covering a wide range of topics presented by highly regarded experts in the field.

These workshops present a fantastic opportunity to interact with leaders in their field, and Study Coordinators will return with a broader insight and appreciation into the world of research in oncology.

Study Coordinator Meeting 1

Co-Chairs: Ms Anne Smith & Mr Andy Phay

“Clinical research is part of an active global oncology community. Study Coordinators and Research Nurses are vital to the constant development of cancer biology and treatment, and it is essential that they develop knowledge and skills in research development and conduct. The Study Coordinator workshop covers a wide range of topics presented by experts in the field. Attendees will gain a broader insight into the world of oncology research.” – Ms Anne Smith

Good Clinical Practice/Risk Based Monitoring/NHMRC Safety Reporting Guidelines – Tanya Symons

“In 2016, the NHMRC published new guidance on ‘Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods’ that substantially changed requirements for Australian sponsors, sites and ethics committees. In 2018, the NHMRC published a suite of additional clinical trial guidance, including Guidance on Reporting Serious Breaches of GCP or the Protocol and Guidance on Risk Based Management and Monitoring of Clinical Trials.

The key aim of the session will be to summarise how these Guidance documents should be operationalised at site level and sponsor level.

The session will cover key content of these documents describing the rationale for their release, demystification of new terminology and also clarification of their interpretation.  The session will also highlight some of the change management issues that have arisen since their release and how trial Trials Coordinators can mitigate these issues.” – Tanya Symons

GI related issues, e.g. biology & pathology of GI cancer Dr Matthew Burge

______________________________________________________

Study Coordinator Meeting 2

Co-Chairs: Ms Nisha Berthon & Jones & Ms Christine Aiken

Effective Scientific Poster creation – Flynn Slattery

Site Accreditation – where is Australia up to and when can courses and programs be implemented? Prof Nik Zeps

Health services / implementation research (‘bench to bedside’/translation of research into practice) – Prof John Simes

 

A tour of the world class South Australian Health & Medical Research Institute (SAHMRI) facility and a presentation on translational research will follow.

In the evening there will be a Welcome Dinner with opportunity to network with senior AGITG members and ASM Invited Faculty.

WEDNESDAY 21 AUGUST

AGITG Early Colorectal Trials Session

  • Associate Professor Michael Jameson SPAR, A randomised, placebo-controlled phase II trial of Simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer
  • Doctor Mark Jeffery ASCOLT, Aspirin for DukesC and High-Risk Dukes B Colorectal Cancers. An International, Multi-centre, Double-Blind, Randomised Placebo Controlled Phase III Trial. Presented with ASCOLT Translational Research
  • Professor Chris Karapetis RENO, Prospective Study of “Watch and Wait” Strategy in Patients with Rectal Cancer who have Developed a Clinical Complete Response with concurrent chemo-radiotherapy: RENO (Rectal Cancer No Operation)
  • Doctor Christina Teng OXTOX, Can Oxaliplatin dose reduction and neurotoxicity be reduced with ibudilast in people with metastatic colorectal cancer – a phase II randomised study

Following the early colorectal trial updates Professor Sharlene Gill will discuss the AGITG portfolio – and how it fits into the international context.

______________________________________________________

AGITG Colorectal Trials Session

  • Associate Professor Niall Tebbutt MODULATE, Modulation of the tumour microinviroment using either vascular disrupting agents or STAT3 inhibition in order to synergise with PD1 inhibition in microsatilite stable, refactory colorectal cancer
  • Associate Professor Niall Tebbutt LIBERATE, A study evaluating liquid biopsies to profile metastatic colorectal cancer
  • Doctor Matthew Burge MONARCC, A randomised phase 2 study of panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer
  • Associate Professor Jeanne Tie DYNAMIC-Rectal, circulating tumour DNA Analysis Informing AdjuvantChemotherapy in Locally Advanced Rectal Cancer: A Multicentre Randomised Study

Presented with DYNAMIC-III, Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Randomised Study.

Following the colorectal trial updates Professor Florian Lordick will discuss the AGITG portfolio – and how it fits into the international context.

THURSDAY 22 AUGUST

A second joint session with Consumers during the ASM will cover topics such as quality of life and survivorship, exercise physiology, supportive care and patient adherence to study treatment.

Combined Consumer-Study Coordinators Session

Joint Consumer / Study Coordinator Forum

Co-Chairs: Ms Jan Mumford & Ms Anne Smith

QOL research & Survivorship (including PROs) – Dr Claudia Rutherford

Exercise physiology & Supportive Care – A/Prof Haryana Dhillon

Patient compliance with study treatments & adherence to study visit scheduleMr Grant Baker & Mr Andy Phay

FRIDAY 23 AUGUST

AGITG Upper GI Cancer Trials Session

  • Professor Desmond Yip ALT-GIST, A randomised Phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST)
  • Professor Andrew Barbour DOCTOR, A Randomised Phase II trial of pre-operative cisplatin, 5 fluorouracil anddocetaxel, +/- Radiotherapy, based on poor early response to standard chemotherapy for resectable adenocarcinoma of the oesophagus and/or gastro oesophageal junction. Presented with DOCTOR Translational Research
  • Professor Trevor Leong TOP GEAR, A randomised II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer
  • Doctor Belinda Lee DYNAMIC-Pancreas, Circulating tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study
  • Doctor Jenny ShannonACTICCA-1, Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma
  • Doctor David Wyld CONTROL NETS, Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study
  • Associate Professor Mustafa Khasraw – NABNEC, A Randomised Phase II Study Of nab-paclitaxel in Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
  • Doctor Andrew Oar – MASTERPLAN, A randomised phase II study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

 Following the Upper GI Cancer trial updates Professor James Abbruzzese will discuss the AGITG portfolio – and how it fits into the international context.