Book Information

Clinical Trials Explained

A Guide to Clinical Trials in the NHS for Healthcare Professionals

Edited by: David Kerr, Kirstine Knox (University of Oxford, Radcliffe Infirmary, Oxford), Diane Robertson (ECRI Health Technology Assessment Group, Plymouth Meeting), Derek Stewart (Gedling Primary Care Trust, Arnold) and Renee Watson (University of Oxford, Radcliffe Infirmary, Oxford)

Published by: Blackwell BMJ Books

Description

• What will happen during and after a clinical trial?
• How will a trial affect my quality of life?
• What are the benefits and risks of a trial?
• What does giving consent mean and what will it involve?
• Will I incur costs during and because of the trial?

These are the questions that should be raised every time a health care professional talks through with a patient the pros and cons of entering a clinical trial.

Clinical Trials Explained has been designed in consultation with doctors and patients who have taken part in trials, providing an essential and detailed guide to the clinical trials process. It therefore helps both clinicians and patients make well-informed decisions on whether to take part in a clinical trial.

TopTable of Contents

Chapter 1 Overview and Purpose of this Guide to Clinical Trials in the NHS
Overview and purpose of this guide
Who should use this guide to clinical trials in the NHS?

Chapter 2 Clinical Trials Explained
What are clinical trials?
Why are clinical trials needed?
Who is involved in a clinical trial?
How are clinical trials designed and approved?
Progression of a medical intervention through the clinical trial phases
Summary

Chapter 3 Clinical Trial Approval, Regulation and Funding
How are clinical trials approved and regulated?
Ethical approval
Informed consent
How are trials managed?
Who pays for a clinical trial?
Summary

Chapter 4 Understanding Clinical Trial Design and Results
Understanding randomisation and blinding in clinical trials
Understanding controls and placebos
Why are placebos used in clinical trials?
What about trials that are not controlled or blinded?
Understanding clinical trial results
Summary

Chapter 5 Questions About Clinical Trials: A Framework for Discussion
What are patients' rights?
Why do patients take part in clinical trials?
Why do patients decline to take part in a clinical trial or withdraw from a clinical trial they are involved in?
How can patients be empowered during their involvement in a
clinical trial?
Will patients involved in clinical trials need extra help and support from
their carers?
What are the likely costs of and reimbursement for patients participating
in clinical trials?
Summary

Appendix A Finding Out About Clinical Trials that are Currently or Soon to be Recruiting
Appendix B ECRI Evidence Report: Patients' Reasons for Participation in Clinical Trials and Effect of Trial Participation on Patient Outcomes
Glossary
Index

TopAbout the Author

Kirstine Knox