Full Description
Today, scientists are expected to be more accountable and transparent than at any other time in history. Globally, the pursuit of knowledge creation enjoys a place of distinction, and the public expects to reap considerable benefits from the innovative contributions made by researchers. It is, therefore, more important than ever that ethics, transparency, and professionalism explicitly guide research integrity.
Despite the clear importance of acquiring a fundamental understanding of clinical trials in the context of health research and innovation, medical training generally fails to cover clinical trial integrity in its curriculum, including it neither at the undergraduate nor at the postgraduate levels. This new book provides a curriculum to address this gap, offering best practice guidelines to improve the quality, openness, and trustworthiness of clinical trials and filling a current void in the market.
Key Features:
The first book on clinical trial integrity
Provides clear guidance on how to ensure probity in peer review, appraisal of trials, and investigation of complaints concerning misconduct in clinical trials
Trains and supports researchers globally on how to undertake trials with integrity
Ensures that the increasing demand for public documentation of all aspects throughout the lifecycle of a clinical trial can be met
This book is essential reading for master and doctoral students undertaking courses in clinical trials, epidemiology, and medical statistics and an invaluable reference for medical journal editors and peer reviewers, clinicians who recruit patients into trials, pharmaceutical industry professionals, patient and public representatives who engage in clinical trials, systematic reviewers, guideline writers, and funders and regulators of clinical trials.
Contents
1. Introduction
2. Randomized clinical trials
3. Integrity of trials
4. Ethics committee approval and participant consent
5. Trial planning
6. Trial oversight
7. Publishing trials responsibly
8. Authorship of trials
9. Evidence syntheses of randomized clinical trials
10. Investigating research misconduct allegations
Suggested reading
Glossary
Index
