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Understanding Clinical Trials and Research a Guide for People Affected by Cancer

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Understanding Clinical Trials and Research a Guide for People Affected by Cancer Understanding Clinical Trials and Research A guide for people affected by cancer Practical and support information For information & support, call Understanding Clinical Trials and Research A guide for people affected by cancer First published April 2012. This edition July 2018. © Cancer Council Australia 2018. ISBN 978 1 925651 28 7 Understanding Clinical Trials and Research is reviewed approximately every 3 years. Check the publication date above to ensure this copy is up to date. Editor: Ruth Sheard. Designer: Paula Marchant. Printer: SOS Print + Media Group. Acknowledgements This edition has been developed by Cancer Council NSW on behalf of all other state and territory Cancer Councils as part of a National Cancer Information Working Group initiative. We thank the reviewers of this booklet: A/Prof Andrew Redfern, Consultant Medical Oncologist, Fiona Stanley Hospital, Clinical Academic Oncologist, The University of Western Australia, and Lead Clinician, State Breast Cancer Collaborative, WA; Christie Allan, Program Coordinator – Clinical Trials, Cancer Council Victoria; Bronwyn Chalmers, Clinical Trial Coordinator, Westmead Breast Cancer Institute, NSW; Sarah Coulson, Coordinator, Oncology Clinical Trials, Projects and Research, Tasmanian Health Service, TAS; Kate Cox, 13 11 20 Consultant, Cancer Council SA; Annette Cubitt, Clinical Trials Manager, Department of Medical Oncology, Cancer Care Services, Royal Brisbane and Women’s Hospital, QLD; Pete Currie, Consumer; Amy Ives, Clinical Trials Coordinator, Department of Medical Oncology, Cancer Care Services, Royal Brisbane and Women’s Hospital, QLD; Sabina Jelinek, Clinical Research Nurse, Murdoch Oncology Clinical Trials Unit, WA; Dr Visalini Nair-Shalliker, Research Fellow – Prostate, Cancer Council NSW; Karlie Neilson, Project Officer – Cancer Research Division, Cancer Council NSW; Prof Mark Rosenthal, Medical Oncologist, and Director, Parkville Cancer Clinical Trials Unit, VIC; Joan Torony, CEO, TROG Cancer Research, NSW; Rebecca Weselman, Senior Clinical Trials Coordinator, Oncology Clinical Trials, St John of God Murdoch Hospital, WA; John Williams, Research Governance Officer, Cancer Council NSW. This booklet is funded through the generosity of the people of Australia. Note to reader Always consult your doctor about matters that affect your health. This booklet is intended as a general introduction to the topic and should not be seen as a substitute for medical, legal or financial advice. You should obtain independent advice relevant to your specific situation from appropriate professionals, and you may wish to discuss issues raised in this book with them. All care is taken to ensure that the information in this booklet is accurate at the time of publication. Please note that information on cancer, including the diagnosis, treatment and prevention of cancer, is constantly being updated and revised by medical professionals and the research community. Cancer Council Australia and its members exclude all liability for any injury, loss or damage incurred by use of or reliance on the information provided in this booklet. Cancer Council Cancer Council is Australia’s peak non-government cancer control organisation. Through the eight state and territory Cancer Councils, we provide a broad range of programs and services to help improve the quality of life of people living with cancer, their families and friends. Cancer Councils also invest heavily in research and prevention. To make a donation and help us beat cancer, visit cancer.org.au or call your local Cancer Council. Cancer Council Australia Level 14, 477 Pitt Street, Sydney NSW 2000 Telephone 02 8063 4100 Facsimile 02 8063 4101 Email [email protected] Website cancer.org.au ABN 91 130 793 725 About this booklet Cancer research is an important part of health care. This booklet has been prepared to help you understand more about clinical research, with a focus on clinical trials. We hope this booklet helps you make an informed decision about taking part in cancer research. It provides an overview of different types of health research and outlines how to get involved in a clinical trial. It includes practical issues to consider when deciding whether to take part. We cannot give advice about whether you should join a clinical trial. You need to discuss this with your doctors. However, this information may answer some of your questions and help you think about what to ask the clinical trials team (see pages 54–55 for a question checklist). This booklet does not need to be read from cover to cover – just read the parts that are useful to you. You may also like to pass this booklet to family and friends for their information. How this booklet was developed This information was developed with help from a range of health professionals and people who have taken part in clinical trials. If you or your family have any questions, call Cancer Council 13 11 20. We can send you more information and connect you with support services in your area. You can also visit your local Cancer Council website (see back cover). Contents Key questions ................................................................... 4 What is health research? ......................................................................... 4 Why is health research important? .......................................................... 4 What are the different types of health research? .................................... 4 What is a clinical trial? ............................................................................. 8 Why participate in research? ................................................................... 8 Who can participate in research? ............................................................ 9 Where does research take place? ........................................................... 9 Is research safe? ................................................................................... 10 Who funds cancer research? ................................................................ 10 Who is the trial sponsor? ....................................................................... 11 Types of clinical research .............................................. 13 Clinical trials .......................................................................................... 13 Behavioural research ............................................................................. 14 Translational research ............................................................................ 15 Regulation of clinical research ...................................... 16 Human research ethics committee ....................................................... 17 Clinical trials explained .................................................. 21 The phases of a clinical trial .................................................................. 21 Health professionals and researchers you may see .............................. 24 Types of clinical trials ............................................................................ 26 Deciding to take part...................................................... 32 Frequently asked questions .................................................................. 33 A second opinion .................................................................................. 36 Joining a study ................................................................ 37 How to find a study ............................................................................... 37 Australian clinical trials websites ........................................................... 38 Taking part in a study ............................................................................ 40 Informed consent .................................................................................. 41 Being part of a clinical trial .................................................................... 45 Withdrawing from a study ..................................................................... 47 Finding trial results ................................................................................ 48 Seeking support ............................................................. 50 Caring for someone with cancer .................................. 53 Question checklist .......................................................... 54 Glossary .......................................................................... 56 Notes ............................................................................... 62 How you can help ........................................................... 64 Key questions Q: What is health research? A: Health research refers to the many types of scientific investigations that aim to test ideas, answer questions, improve treatment options and increase knowledge about human health. Q: Why is health research important? A: What we know about cancer changes over time as more research is done. Health research has led to the medical treatments and health programs available today. These advances have helped the five-year survival rate for all cancers to rise from 52% to 68% over the past 20 years.1 The search for better ways to prevent, diagnose and treat human diseases is ongoing. It requires the active participation of patients, carers and healthy people. Q: What are the different types of health research? A: There are three main types of health research: population research, laboratory research and clinical research (see table on pages 6–7). People affected by cancer mainly take part
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