Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals

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.

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