Today scientists are expected to be more accountable and transparent than at any time in history. Globally the pursuit of knowledge creation enjoys a place of distinction, and the public expects to reap considerable benefit 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 undergraduate nor at 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 in how to undertake trials with integrity.
- Ensures the increasing demand for public documentation of all aspects throughout the lifecycle of a clinical trial can be met.
The 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, funders and regulators of clinical trials.
Today scientists are expected to be more accountable and transparent than at any time in history. Globally the pursuit of knowledge creation enjoys a place of distinction, and the public expects to reap considerable benefit from the innovative contributions made by researchers.
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
Khalid S. Khan is Beatriz Galindo Distinguished Investigator at the University of Granada, Spain, and has been Sims Black Fellow of the UK Royal College of Obstetricians and Gynaecologists, Spinoza Professor at the University of Amsterdam, the Netherlands, Fellow of the Pakistani College of Physicians and Surgeons, and Fellow of the UK Higher Education Academy.
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